Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer
ETNA
2 other identifiers
interventional
632
6 countries
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Apr 2013
Longer than P75 for phase_3 breast-cancer
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMarch 7, 2024
March 1, 2024
3.4 years
March 25, 2013
March 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pathologic Complete Response (pCR)
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.
At the time of surgery: 40 months after the randomization of the first patient
Secondary Outcomes (7)
clinical Overall Response (cOR)
At the time of surgery: 40 months after the randomization of the first patient
Event Free Survival (EFS)
5 years after the first patient in and 10 years after randomization of last patient in
Distant Event Free Survival (DEFS)
5 years after the first patient in and 10 years after randomization of last patient in
Local Event Free Survival
5 years after the first patient in and 10 years after randomization of last patient in
Regional Event Free Survival
5 years after the first patient in and 10 years after randomization of last patient in
- +2 more secondary outcomes
Study Arms (2)
Paclitaxel
ACTIVE COMPARATORPaclitaxel 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
Abraxane
EXPERIMENTALAbraxane 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 500, Australia
Peter McCallum Cancer Centre
East Melbourne, Victoria, 8006, Australia
Peter MacCallum Cancer Centre Department of Surgical Oncology
East Melbourne, Victoria, 8600, Australia
Eastern Health Breast Cancer Research - Maroondah Breast Clinic
Ringwood East, Victoria, 3135, Australia
Eastern Health Breast Cancer Research Maroondah Breast Clinic
Ringwood East, Victoria, 3135, Australia
Mount Hospital - Breast Clinical Trials Unit
Perth, Western Australia, 6000, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Klinikum Augsburg International Patient Service
Augsburg, 86156, Germany
Frauenarzt-Zentrum-Zehlendorf
Berlin, 14169, Germany
Augusta-Kranken-Anstalt gGmbH Klinik für Hämatologie, Onkologie & Palliativmedizin
Bochum, 44791, Germany
St.Elisabeth-Krankenhaus Brustzentrum
Cologne, 50935, Germany
Universitätsklinikum Erlangen - Frauenklinik - Poliklinik
Erlangen, 91054, Germany
Agaplesion Markus Hospital - Frankfurt
Frankfurt, 60389, Germany
Bethanien-Krankenhaus Onkologisches Zentrum
Frankfurt, 60389, Germany
Mammazentrum - Hamburg am Krankenhaus Jerusalem
Hamburg, 20357, Germany
Gynäkologisch-Onkologische Praxis
Hanover, 30177, Germany
Interdisciplinary Oncology Center
Munich, 80336, Germany
Praxis Gynäkologie Arabella
Munich, 81925, Germany
Onkologische Schwerpunktpraxis
Speyer, 67346, Germany
Cliniche Gavazzeni - Humanitas Gavazzeni
Bergamo, BG, 24125, Italy
Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Cona, Ferrara, 44124, Italy
IST San Martino
Genova, GE, 16132, Italy
A.O. San Gerardo
Monza, MB, 20050, Italy
A.O. Ospedale Civile di Legnano
Legnano, MI, 20025, Italy
Ospedale San Raffaele
Milan, MI, 20132, Italy
Fondazione IRCCS Istituto nazionale dei tumori
Milan, MI, 20133, Italy
A.O. Ospedale Luigi Sacco
Milan, MI, 20160, Italy
A.O. Ospedale Niguarda Ca' Granda
Milan, MI, 20162, Italy
ULSS 15 Alta Padovana
Camposampiero, PD, 35012, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, RE, 42123, Italy
Ospedale Santa Maria della Misericordia
Udine, UD, 33100, Italy
Azienda ULSS 6 di Vicenza
Vicenza, VI, 36100, Italy
NN Petrov Research Institute of Oncology
Saint Petersburg, Russia
National Cancer Centre Singapore
Singapore, 169610, Singapore
Hospital Clinico Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Miguel Servet University Hospital
Zaragoza, Aragon, 50009, Spain
Hospital Son Llàtzer Palma de Mallorca
Palma de Mallorca, Balearic Islands, 2002, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Hospital Universitario Fundacion Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Centro Oncologico de Galicia
A Coruña, 15009, Spain
Hospital Teresa Herrera (Chuac)
A Coruña, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, 05004, Spain
Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic i Provencial
Barcelona, 08036, Spain
Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Onkologikoa
Donostia / San Sebastian, 20014, Spain
Complejo Hospitalario de Jaen
Jaén, 23007, Spain
Hospital Universitari Arnau de Vilanove de Lleida
Lleida, 25198, Spain
Gregorio Maraňón Hospital
Madrid, 28009, Spain
Hospital La Paz
Madrid, 28046, Spain
MD Anderson Cancer Center Madrid
Madrid, Spain
J.M. Morales Meseguer, Universitary Hospital Marques in los Velez
Murcia, 30080, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Donostia
San Sebastián, 20080, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen Macarena
Seville, 41071, Spain
Hospital Virgen de la Salud
Toledo, Spain
Instituto Valenciano Oncologia
Valencia, 46009, Spain
Hospital Clinico Universita Valencia
Valencia, Spain
Related Publications (1)
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.
PMID: 29327055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luca Gianni, MD
San Raffaele Hospital, Milan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2013
First Posted
April 2, 2013
Study Start
April 1, 2013
Primary Completion
September 1, 2016
Study Completion
March 1, 2023
Last Updated
March 7, 2024
Record last verified: 2024-03