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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01923168
Registration number
NCT01923168
Ethics application status
Date submitted
13/08/2013
Date registered
15/08/2013
Date last updated
14/09/2018
Titles & IDs
Public title
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
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Scientific title
A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer
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Secondary ID [1]
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2013-001862-41
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Secondary ID [2]
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CBYL719A2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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0
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Condition category
Condition code
Cancer
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - alpelisib
Treatment: Drugs - buparlisib
Treatment: Drugs - Placebo
Experimental: Alpelisib + Letrozole - Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
Experimental: Buparlisib + Letrozole - Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
Placebo Comparator: Placebo + Letrozole - Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
Treatment: Drugs: alpelisib
BYL719 + Letrozole
Treatment: Drugs: buparlisib
BKM120 + Letrozole
Treatment: Drugs: Placebo
Placebo (of BYL719 or BKM120) + Letrozole
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort
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Assessment method [1]
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Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.
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Timepoint [1]
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After 24 weeks of treatment
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Primary outcome [2]
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Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort
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Assessment method [2]
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Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.
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Timepoint [2]
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After 24 weeks of treatment
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Primary outcome [3]
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Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
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Assessment method [3]
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Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.
BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to < 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline = 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.
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Timepoint [3]
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After 24 weeks of treatment
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Primary outcome [4]
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Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
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Assessment method [4]
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Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.
BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to < 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline = 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.
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Timepoint [4]
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After 24 weeks of treatment
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Secondary outcome [1]
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pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Mutant Cohort Based on ctDNA
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Assessment method [1]
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pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment
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Timepoint [1]
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After 24 weeks of treatment
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Secondary outcome [2]
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pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Wild-type Cohort Based on ctDNA
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Assessment method [2]
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pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment
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Timepoint [2]
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After 24 weeks of treatment
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Secondary outcome [3]
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Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
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Assessment method [3]
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Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.
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Timepoint [3]
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After 24 weeks of treatment
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Secondary outcome [4]
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Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
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Assessment method [4]
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Breast conserving surgery is defined as the percentage of participants with no mastectomy following completion of 24 weeks of treatment. Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.
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Timepoint [4]
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After 24 weeks of treatment
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Secondary outcome [5]
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Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR
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Assessment method [5]
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Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR
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Timepoint [5]
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Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)
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Secondary outcome [6]
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Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR
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Assessment method [6]
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Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.
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Timepoint [6]
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Baseline, Cycle 1 Day 15 (each cycle is 28 days ) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)
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Secondary outcome [7]
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Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR
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Assessment method [7]
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Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR
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Timepoint [7]
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Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)
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Secondary outcome [8]
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Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR
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Assessment method [8]
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Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR
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Timepoint [8]
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Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)
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Secondary outcome [9]
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Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort
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Assessment method [9]
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Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA mutant cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.
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Timepoint [9]
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At the time of surgery (expected after 24 weeks of treatment)
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Secondary outcome [10]
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Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort
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Assessment method [10]
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Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA wild-type cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.
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Timepoint [10]
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0
At the time of surgery (expected after 24 weeks of treatment)
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Secondary outcome [11]
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Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
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Assessment method [11]
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Summary of primary PK parameters for alpelisib plasma concentration
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Timepoint [11]
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0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [12]
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Alpelisib PK Parameter: Cmax at Cycle 1 Day 1
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Assessment method [12]
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Summary of primary PK parameters for alpelisib plasma concentration
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Timepoint [12]
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Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [13]
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Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1
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Assessment method [13]
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Summary of primary PK parameters for alpelisib plasma concentration
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Timepoint [13]
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Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [14]
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Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1
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Assessment method [14]
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Summary of primary PK parameters for alpelisib plasma concentration
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Timepoint [14]
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0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [15]
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Alpelisib PK Parameter: Cmax at Cycle 4 Day 1
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Assessment method [15]
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Summary of primary PK parameters for alpelisib plasma concentration
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Timepoint [15]
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [16]
0
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Alpelisib PK Parameter: Tmax at Cycle 4 Day 1
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Assessment method [16]
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Summary of primary PK parameters for alpelisib plasma concentration
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Timepoint [16]
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [17]
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Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
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Assessment method [17]
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Summary of primary PK parameters for Letrozole plasma concentration
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Timepoint [17]
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0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [18]
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Letrozole PK Parameter: Cmax at Cycle 1 Day 1
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Assessment method [18]
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Summary of primary PK parameters for letrozole plasma concentration
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Timepoint [18]
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Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [19]
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Letrozole PK Parameter: Tmax at Cycle 1 Day 1
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Assessment method [19]
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Summary of primary PK parameters for letrozole plasma concentration
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Timepoint [19]
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Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [20]
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Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1
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Assessment method [20]
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Summary of primary PK parameters for Letrozole plasma concentration
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Timepoint [20]
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0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [21]
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Letrozole PK Parameter: Cmax at Cycle 4 Day 1
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Assessment method [21]
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Summary of primary PK parameters for letrozole plasma concentration
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Timepoint [21]
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [22]
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Letrozole PK Parameter: Tmax at Cycle 4 Day 1
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Assessment method [22]
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Summary of primary PK parameters for letrozole plasma concentration
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Timepoint [22]
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [23]
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Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1
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Assessment method [23]
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Summary of primary PK parameters for Buparlisib plasma concentration
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Timepoint [23]
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0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [24]
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Buparlisib PK Parameter: Cmax at Cycle 1 Day 1
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Assessment method [24]
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Summary of primary PK parameters for buparlisib plasma concentration
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Timepoint [24]
0
0
Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [25]
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Buparlisib PK Parameter: Tmax at Cycle 1 Day 1
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Assessment method [25]
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Summary of primary PK parameters for buparlisib plasma concentration
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Timepoint [25]
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Cycle 1 Day 1 (each cycle is 28 days)
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Secondary outcome [26]
0
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Buparlisib PK Parameter: AUClast at Cycle 4 Day 1
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Assessment method [26]
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Summary of primary PK parameters for Buparlisib plasma concentration
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Timepoint [26]
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0
0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [27]
0
0
Buparlisb PK Parameter: Cmax at Cycle 4 Day 1
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Assessment method [27]
0
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Summary of primary PK parameters for buparlisib plasma concentration
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Timepoint [27]
0
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [28]
0
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Buparlisib PK Parameter: Tmax at Cycle 4 Day 1
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Assessment method [28]
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Summary of primary PK parameters for buparlisib plasma concentration
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Timepoint [28]
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Cycle 4 Day 1 (each cycle is 28 days)
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Eligibility
Key inclusion criteria
1. Patient is an adult, female = 18 years old at the time of informed consent
2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer
3. Patient is postmenopausal.
4. Patient has T1c-T3, any N, M0, operable breast cancer
5. Patients must have measurable disease
6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67
level.
7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local
laboratory testing
8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization
test or an IHC status of 0 or 1+ as per local laboratory testing
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient has locally recurrent or metastatic disease
2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy,
immunotherapy) or radiotherapy for current breast cancer disease before randomization.
3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes
mellitus
4. History of acute pancreatitis within 1 year of study entry
5. Uncontrolled hypertension
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/07/2017
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Sample size
Target
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Accrual to date
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Final
340
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Kingswood
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Alabama
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Country [2]
0
0
United States of America
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0
Arkansas
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0
0
United States of America
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California
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0
United States of America
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Georgia
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0
0
United States of America
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Maryland
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0
0
United States of America
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Massachusetts
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United States of America
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Minnesota
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0
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New Jersey
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0
United States of America
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North Carolina
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0
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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0
United States of America
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Virginia
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0
0
United States of America
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Washington
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0
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Austria
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Tyrol
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0
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Austria
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0
Vorarlberg
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0
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Austria
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Leoben
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0
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Austria
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Rankweil
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0
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Austria
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Salzburg
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0
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Austria
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Vienna
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0
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Austria
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Villach
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Leuven
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Belgium
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Sint Niklaas
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Brazil
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GO
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0
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Brazil
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0
Rio Grande Do Sul
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Brazil
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SP
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Bulgaria
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Shumen
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Bulgaria
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Sofia
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0
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Bulgaria
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Varna
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Canada
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British Columbia
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Canada
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Antioquia
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Berlin
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Kiel
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Germany
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Koeln
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Hong Kong
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Hong Kong SAR
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Israel
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Haifa
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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BS
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Italy
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CR
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Italy
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MC
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Italy
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MI
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Italy
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Napoli
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Japan
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Aichi
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Japan
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Hiroshima
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Niigata
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Lebanon
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Ashrafieh
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Lebanon
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Beirut
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Lebanon
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Saida
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Netherlands
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Delft
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Netherlands
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Den Haag
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Netherlands
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Leiden
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Netherlands
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Tilburg
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Spain
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Andalucia
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Spain
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Catalunya
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Pais Vasco
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Spain
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus
letrozole led to an increase in pathologic clinical response and Objective Response Rate
compared to treatment with placebo plus letrozole in patients with Breast cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01923168
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01923168
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