Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03916744
Registration number
NCT03916744
Ethics application status
Date submitted
10/04/2019
Date registered
16/04/2019
Titles & IDs
Public title
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
Query!
Scientific title
A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
Query!
Secondary ID [1]
0
0
2018-003798-85
Query!
Secondary ID [2]
0
0
GO40987
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Giredestrant
Treatment: Surgery - Surgery
Experimental: Giredestrant 10 mg -
Experimental: Giredestrant 30 mg -
Experimental: Giredestrant 100 mg -
Treatment: Drugs: Giredestrant
Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).
Treatment: Surgery: Surgery
Breast cancer surgery will take place on Day 15 (+/-2 days).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples
Query!
Assessment method [1]
0
0
The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the proportion of nuclei staining Ki67-positive (Ki67+) in the tumor biopsy sample taken post-treatment (at surgery) relative to that in the pre-treatment sample (at baseline).
Query!
Timepoint [1]
0
0
Baseline and Surgery (Day 15)
Query!
Primary outcome [2]
0
0
Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples
Query!
Assessment method [2]
0
0
The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the percentage of nuclei staining Ki67-positive (Ki67+) in the pre- and post-treatment tumor biopsy samples (taken at baseline and surgery, respectively) and the absolute difference in the percentage of Ki67+ nuclei between the two samples (calculated as surgery minus baseline).
Query!
Timepoint [2]
0
0
Baseline and Surgery (Day 15)
Query!
Secondary outcome [1]
0
0
Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
Query!
Assessment method [1]
0
0
All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. Investigators used their knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an AE was considered to be related to the study drug.
Query!
Timepoint [1]
0
0
From Baseline to Day 43
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Abnormal Vital Signs During Treatment
Query!
Assessment method [2]
0
0
Vital signs, which included diastolic and systolic blood pressure, pulse rate, and body temperature, were measured while the participant was sitting and according to institutional practices. Any of the vital signs that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). A vital sign result had to be reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Query!
Timepoint [2]
0
0
Baseline, Days 1, 8, and 15
Query!
Secondary outcome [3]
0
0
Change From Baseline in Pulse Rate
Query!
Assessment method [3]
0
0
Pulse rate was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Query!
Timepoint [3]
0
0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Query!
Secondary outcome [4]
0
0
Change From Baseline in Systolic Blood Pressure
Query!
Assessment method [4]
0
0
Systolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Query!
Timepoint [4]
0
0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Query!
Secondary outcome [5]
0
0
Change From Baseline in Diastolic Blood Pressure
Query!
Assessment method [5]
0
0
Diastolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Query!
Timepoint [5]
0
0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Query!
Secondary outcome [6]
0
0
Change From Baseline in Body Temperature
Query!
Assessment method [6]
0
0
Body temperature was measured according to institutional practice. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug.
Query!
Timepoint [6]
0
0
Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43)
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline
Query!
Assessment method [7]
0
0
Laboratory parameters for hematology will be measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Query!
Timepoint [7]
0
0
Baseline, Days 1, 8, and 15
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline
Query!
Assessment method [8]
0
0
Laboratory parameters for blood chemistry and coagulation were measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase
Query!
Timepoint [8]
0
0
Baseline, Days 1, 8, and 15
Query!
Secondary outcome [9]
0
0
Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment
Query!
Assessment method [9]
0
0
Electrocardiogram (ECG) recordings were performed after the participant had been resting in a supine position for at least 10 minutes. ECG parameters included heart rate, PR and QRS durations, and QT and QTcF intervals. Per the protocol, ECG readings post-treatment were limited to those for whom it was clinically indicated. Any of the ECG parameters that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). An ECG test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment.
Query!
Timepoint [9]
0
0
Baseline, Days 1, 8, and 15
Query!
Secondary outcome [10]
0
0
Plasma Concentration of Giredestrant at Steady State by Dose Level
Query!
Assessment method [10]
0
0
Plasma samples were obtained on the day of surgery (Day 15), or prior to biopsy on Day 14.
Query!
Timepoint [10]
0
0
Predose on day of surgery (Day 15), or prior to biopsy (Day 14)
Query!
Eligibility
Key inclusion criteria
* Ability to comply with the study protocol, in the investigator's judgment
* Histologically confirmed invasive breast carcinoma, with all of the following characteristics: Primary tumor greater than or equal to (=)1.5 centimeters (cm) in largest diameter by ultrasound; Stage I-III operable breast cancer; Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice.
* ER-positive tumor and HER2-negative breast cancer as per local laboratory testing
* Postmenopausal status
* Breast cancer eligible for primary surgery
* Submission of a representative tumor tissue specimen
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (=)1
* Adequate organ function
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Diagnosis of inflammatory breast cancer
* Diagnosis of bilateral breast cancer
* Concurrent use of hormone replacement therapies
* Previous systemic or local treatment for the primary breast cancer currently under investigation
* Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
* Current treatment with any systemic anti-cancer therapies
* Major surgery within 4 weeks prior to enrollment
* Radiation therapy within 2 weeks prior to enrollment
* Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
* Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
* Known HIV infection
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
* History of allergy to giredestrant or any of its excipients
* Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytic drugs
* History of documented hemorrhagic diathesis or coagulopathy
* History or presence of symptomatic bradycardia or sick sinus syndrome
* Baseline heart rate =55 beats per minute (bpm) prior to enrollment
* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
* QT interval corrected through use of Fridericia's formula (QTcF) >470 milliseconds demonstrated by at least two ECGs >30 minutes apart
* History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
* Current treatment with medications that are well known to prolong the QT interval
* History or presence of uncontrolled hypothyroidism
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/07/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
25/05/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
75
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
St Vincent's Hospital Sydney - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Sunshine Hospital - St Albans
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
3021 - St Albans
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Massachusetts
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
New York
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Auderghem
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Edegem
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Namur
Query!
Country [7]
0
0
Spain
Query!
State/province [7]
0
0
Guipuzcoa
Query!
Country [8]
0
0
Spain
Query!
State/province [8]
0
0
Barcelona
Query!
Country [9]
0
0
Spain
Query!
State/province [9]
0
0
Madrid
Query!
Country [10]
0
0
Spain
Query!
State/province [10]
0
0
Valencia
Query!
Country [11]
0
0
United Kingdom
Query!
State/province [11]
0
0
London
Query!
Country [12]
0
0
United Kingdom
Query!
State/province [12]
0
0
Truro
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Genentech, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03916744
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/44/NCT03916744/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/44/NCT03916744/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03916744