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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01822314
Registration number
NCT01822314
Ethics application status
Date submitted
25/03/2013
Date registered
2/04/2013
Date last updated
7/03/2024
Titles & IDs
Public title
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer
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Scientific title
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer " ETNA (Evaluating Treatment With Neoadjuvant Abraxane)
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Secondary ID [1]
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2012-003481-41
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Secondary ID [2]
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FM-12-B01
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Universal Trial Number (UTN)
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Trial acronym
ETNA
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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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Condition category
Condition code
Cancer
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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 - Abraxane
Treatment: Drugs - Paclitaxel
Active comparator: Paclitaxel - Paclitaxel will be given on week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles.
AC or EC or FEC will then be given on day 1 every 3 weeks for 4 cycles
Experimental: Abraxane - Abraxane will be given at the dosage of 125 mg/m2 on week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles.
AC or EC or FEC will then be given on day 1 every 3 weeks for 4 cycles
Treatment: Drugs: Abraxane
Abraxane at the dosage of 125 mg/m2 will be delivered over 30 minutes on week 1, 2 and 3 followed by 1 week rest. week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
Treatment: Drugs: Paclitaxel
Paclitaxel at the dosage of 90 mg/m2 diluted in 250 mL of water for injection (WFI) over 1 hour given week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
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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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pathologic Complete Response (pCR)
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Assessment method [1]
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To compare the rate of pathologic Complete Response (pCR, absence of invasive disease in breast and nodes (ypT0/ypTis, ypN0)) for abraxane (Abraxane®, abraxane) vs paclitaxel.
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Timepoint [1]
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At the time of surgery: 40 months after the randomization of the first patient
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Secondary outcome [1]
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clinical Overall Response (cOR)
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Assessment method [1]
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To compare the rate of clinical overall response (cOR) after the first 4 cycles of abraxane vs paclitaxel and to compare the rate of cOR after the entire preoperative chemotherapy (i.e. before surgery) in the study arms of abraxane vs paclitaxel
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Timepoint [1]
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At the time of surgery: 40 months after the randomization of the first patient
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Secondary outcome [2]
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Event Free Survival (EFS)
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Assessment method [2]
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To compare the Event Free Survival (EFS, i.e. disease progression while on primary therapy or disease recurrence after surgery) in the study arms of abraxane vs paclitaxel
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Timepoint [2]
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5 years after the first patient in and 10 years after randomization of last patient in
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Secondary outcome [3]
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Distant Event Free Survival (DEFS)
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Assessment method [3]
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The distant event free survival (DEFS) is defined as the time from randomization to the first date of distant metastasis while on primary therapy or distant recurrence after surgery or death due to any cause. Patients who terminate the study without evidence of any of the above events will be censored at the date of their last follow-up tumor assessment
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Timepoint [3]
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5 years after the first patient in and 10 years after randomization of last patient in
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Secondary outcome [4]
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Local Event Free Survival
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Assessment method [4]
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The local event free survival (LEFS) is defined as the time from randomization to the first date of local progression while on primary therapy or local recurrence after surgery. Rules for censoring and methods of analysis will be the same as defined for EFS
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Timepoint [4]
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5 years after the first patient in and 10 years after randomization of last patient in
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Secondary outcome [5]
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Regional Event Free Survival
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Assessment method [5]
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The regional event free survival (REFS) is defined as the time from randomization to the first date of regional progression while on primary therapy or regional recurrence after surgery. Rules for censoring and methods of analysis will be the same as defined for EFS.
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Timepoint [5]
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5 years after the first patient in and 10 years after randomization of last patient in
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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The overall survival (OS) is defined as the time from randomization to the date of death. Patients alive at the end of study will be censored at their last contact date.
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Timepoint [6]
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13 years from the date of first patient in
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Secondary outcome [7]
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Safety and Tolerability
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Assessment method [7]
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Patients will be assessed for adverse events by clinical examination, questioning for symptoms of toxicity, laboratory assessments, vital signs, ECG and LVEF.
Neurological toxicity and other toxicities will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0.
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Timepoint [7]
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Each participant will be followed for the duration of treatment period, approximately 9 months
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Eligibility
Key inclusion criteria
* Female patients aged 18 years or older
* Histologically confirmed invasive unilateral breast cancer
* HER2-negative disease
* Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PgR]), tumor grade and, if institutional standard permits, known Ki67 value
* Available paraffin-embedded tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, hormone receptor status, Ki67 value and biomarker evaluation is mandatory
* One of the following clinical stages:
* T2, T3, T4 disease, triple negative (HER2, ER, PgR)
* T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumor grade (G II-III)
* ECOG performance status 0 or 1
* Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
* Willing and able to comply with the protocol
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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
* Synchronous contralateral breast cancer or presence of metastatic disease (M1). Exception: contralateral insitu ductal cancer
* Surgical axillary staging procedure prior to study entry. Exceptions: 1) Fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted
* Pregnant or lactating women.
* Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, for example abstinence, an intra-uterine device, or double barrier method of contraception
* Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
* Previous investigational treatment for any condition within 4 weeks of randomization date
* Patients on therapy with a strong CYP3A4 inhibitor and on therapy with Warfarin (Coumadin)
* Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible.
* Pre-existing motor or sensory neuropathy of grade > 1 for any reason
* Patients with a history of hypersensitivity due to drugs containing polyoxyethylene castor oil (Cremophor EL) (e.g., ciclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc.)
* Other serious illness or medical condition including: history of documented congestive cardiac failure; angina pectoris requiring anti-anginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
* Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs
* Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus
* Hematology and biochemistry tests within normla limits
* Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA)
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/04/2013
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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
1/03/2023
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Sample size
Target
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Accrual to date
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Final
632
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Peter McCallum Cancer Centre - East Melbourne
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre Department of Surgical Oncology - East Melbourne
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Recruitment hospital [4]
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Eastern Health Breast Cancer Research - Maroondah Breast Clinic - Ringwood East
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Recruitment hospital [5]
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Eastern Health Breast Cancer Research Maroondah Breast Clinic - Ringwood East
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Recruitment hospital [6]
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Mount Hospital - Breast Clinical Trials Unit - Perth
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Recruitment hospital [7]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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500 - Adelaide
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Recruitment postcode(s) [3]
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8006 - East Melbourne
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Recruitment postcode(s) [4]
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8600 - East Melbourne
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Recruitment postcode(s) [5]
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3135 - Ringwood East
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Recruitment postcode(s) [6]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Köln
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Germany
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Munich
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Germany
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Speyer
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Italy
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BG
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Italy
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BO
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Italy
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Ferrara
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Italy
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GE
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Italy
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MB
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Italy
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MI
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Italy
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PD
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Italy
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PV
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Italy
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RE
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Italy
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UD
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Italy
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VI
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Aragon
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Baleares
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Barcelona
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Madrid
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Tenerife
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Spain
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A Coruña
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Spain
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Alicante
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Spain
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Badalona
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Caceres
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Córdoba
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Donostia
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Jaen
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La Coruna
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Lleida
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Spain
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Murcia
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Salamanca
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Spain
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San Sebastián
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Spain
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Sevilla
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Toledo
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Valencia
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Ávila
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Funding & Sponsors
Primary sponsor type
Other
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Name
Fondazione Michelangelo
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery.
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Trial website
https://clinicaltrials.gov/study/NCT01822314
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Trial related presentations / publications
Gianni L, Mansutti M, Anton A, Calvo L, Bisagni G, Bermejo B, Semiglazov V, Thill M, Chacon JI, Chan A, Morales S, Alvarez I, Plazaola A, Zambetti M, Redfern AD, Dittrich C, Dent RA, Magazzu D, De Fato R, Valagussa P, Tusquets I. Comparing Neoadjuvant Nab-paclitaxel vs Paclitaxel Both Followed by Anthracycline Regimens in Women With ERBB2/HER2-Negative Breast Cancer-The Evaluating Treatment With Neoadjuvant Abraxane (ETNA) Trial: A Randomized Phase 3 Clinical Trial. JAMA Oncol. 2018 Mar 1;4(3):302-308. doi: 10.1001/jamaoncol.2017.4612.
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Public notes
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Contacts
Principal investigator
Name
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Luca Gianni, MD
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Address
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San Raffaele Hospital, Milan
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01822314
Download to PDF