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Breast CancerPhase 3ETNANCT01822314

Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer

A Phase 3 study testing Abraxane and Paclitaxel in people with Breast Cancer, run by Fondazione Michelangelo at 67 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Abraxane and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
632 participants
Where
67 sitesin 6 countries
Study dates
Apr 2013to Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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)

Trial locations and contacts

67 sites in 6 countries.

67 sites in 6 countries

Spain30 sites

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Hospital Teresa Herrera (Chuac)

    A Coruña

  • Hospital Universitario Fundacion Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05004

  • Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic i Provencial

    Barcelona, 08036

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Onkologikoa

    Donostia / San Sebastian, 20014

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Universitari Arnau de Vilanove de Lleida

    Lleida, 25198

  • Gregorio Maraňón Hospital

    Madrid, 28009

  • Hospital La Paz

    Madrid, 28046

  • MD Anderson Cancer Center Madrid

    Madrid

  • J.M. Morales Meseguer, Universitary Hospital Marques in los Velez

    Murcia, 30080

  • Hospital Son Llàtzer Palma de Mallorca

    Palma de Mallorca, Balearic Islands, 2002

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Universitario Donostia

    San Sebastián, 20080

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41071

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Virgen de la Salud

    Toledo

  • Instituto Valenciano Oncologia

    Valencia, 46009

  • Hospital Clinico Universita Valencia

    Valencia

  • Hospital Clinico Lozano Blesa

    Zaragoza, Aragon, 50009

  • Miguel Servet University Hospital

    Zaragoza, Aragon, 50009

Other trials in Spain

Italy15 sites

  • Cliniche Gavazzeni - Humanitas Gavazzeni

    Bergamo, BG, 24125

  • Policlinico Sant'Orsola Malpighi

    Bologna, BO, 40138

  • ULSS 15 Alta Padovana

    Camposampiero, PD, 35012

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

    Cona, Ferrara, 44124

  • IST San Martino

    Genova, GE, 16132

  • A.O. Ospedale Civile di Legnano

    Legnano, MI, 20025

  • Ospedale San Raffaele

    Milan, MI, 20132

  • Fondazione IRCCS Istituto nazionale dei tumori

    Milan, MI, 20133

  • A.O. Ospedale Luigi Sacco

    Milan, MI, 20160

  • A.O. Ospedale Niguarda Ca' Granda

    Milan, MI, 20162

  • A.O. San Gerardo

    Monza, MB, 20050

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV, 27100

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, RE, 42123

  • Ospedale Santa Maria della Misericordia

    Udine, UD, 33100

  • Azienda ULSS 6 di Vicenza

    Vicenza, VI, 36100

Other trials in Italy

Germany12 sites

  • Klinikum Augsburg International Patient Service

    Augsburg, 86156

  • Frauenarzt-Zentrum-Zehlendorf

    Berlin, 14169

  • Augusta-Kranken-Anstalt gGmbH Klinik für Hämatologie, Onkologie & Palliativmedizin

    Bochum, 44791

  • St.Elisabeth-Krankenhaus Brustzentrum

    Cologne, 50935

  • Universitätsklinikum Erlangen - Frauenklinik - Poliklinik

    Erlangen, 91054

  • Agaplesion Markus Hospital - Frankfurt

    Frankfurt, 60389

  • Bethanien-Krankenhaus Onkologisches Zentrum

    Frankfurt, 60389

  • Mammazentrum - Hamburg am Krankenhaus Jerusalem

    Hamburg, 20357

  • Gynäkologisch-Onkologische Praxis

    Hanover, 30177

  • Interdisciplinary Oncology Center

    Munich, 80336

  • Praxis Gynäkologie Arabella

    Munich, 81925

  • Onkologische Schwerpunktpraxis

    Speyer, 67346

Other trials in Germany

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Adelaide Hospital

    Adelaide, South Australia, 500

  • Peter McCallum Cancer Centre

    East Melbourne, Victoria, 8006

  • Peter MacCallum Cancer Centre Department of Surgical Oncology

    East Melbourne, Victoria, 8600

  • Mount Hospital - Breast Clinical Trials Unit

    Perth, Western Australia, 6000

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Eastern Health Breast Cancer Research - Maroondah Breast Clinic

    Ringwood East, Victoria, 3135

  • Eastern Health Breast Cancer Research Maroondah Breast Clinic

    Ringwood East, Victoria, 3135

Other trials in Australia

Russia1 site

  • NN Petrov Research Institute of Oncology

    Saint Petersburg

Other trials in Russia

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer " ETNA (Evaluating Treatment With Neoadjuvant Abraxane)

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.

Read the detailed description

In this study, eligible and consenting patients will be randomized to receive either 4 cycles of weekly abraxane (nab-paclitaxel) followed by 4 cycles of an anthracycline-containing regimen or 4 cycles of weekly paclitaxel followed by 4 cycles of an anthracycline-containing regimen.The anthracycline regimen (AC, EC or FEC) will be chosen by the investigator at the participating sites.

Before randomization patients will be stratified according to Disease stage [operable (tumor stage: T2N0-1; T3N0) and locally advanced (T3N1;T4, any N2-3)] and Tumor subtype [luminal B intermediate (HER2 negative, ER or PGR positive, Ki67 from 14% to 20%) vs luminal B high (HER2 negative, ER or PGR positive, Ki67 >20%) vs triple negative tumors (HER2 negative, ER negative and PgR negative, Ki67 any value)]. Tumor subtype will be confirmed at two selected referral laboratories.

Neoadjuvant chemotherapy will be followed by definite surgery and irradiation as per international and local guidelines.

During neoadjuvant chemotherapy patients will be assessed for safety and efficacy as detailed in the protocol.

After definite surgery patients will be followed for approximately 10 years according to local procedures

Conditions
Breast Cancer
Being tested
Abraxane, Paclitaxel
Keywords
breast, cancer, unilateral, non metastatic, HER2 negative
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbraxaneDrug

    Also called Nab-paclitaxel

    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

  • PaclitaxelDrug

    Also called No specific brand name

    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

Study groups in NCT01822314
Study groupRoleWhat they receive
PaclitaxelActive 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
Receives: Drug: Paclitaxel
AbraxaneExperimentalAbraxane 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
Receives: Drug: Abraxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At the time of surgery: 40 months after the randomization of the first patient

Secondary outcomes (7)

  1. clinical Overall Response (cOR)

    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

    Measured: At the time of surgery: 40 months after the randomization of the first patient

  2. Event Free Survival (EFS)

    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

    Measured: 5 years after the first patient in and 10 years after randomization of last patient in

  3. Distant Event Free Survival (DEFS)

    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

    Measured: 5 years after the first patient in and 10 years after randomization of last patient in

  4. Local Event Free Survival

    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

    Measured: 5 years after the first patient in and 10 years after randomization of last patient in

  5. Regional Event Free Survival

    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.

    Measured: 5 years after the first patient in and 10 years after randomization of last patient in

  6. Overall Survival (OS)

    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.

    Measured: 13 years from the date of first patient in

  7. Safety and Tolerability

    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.

    Measured: Each participant will be followed for the duration of treatment period, approximately 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionSep 2016
  4. Study completionMar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
632 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01822314
Sponsor's protocol ID
FM-12-B01
Other IDs
2012-003481-41
Acronym
ETNA
Status last verified
Mar 2024
First submitted
25 Mar 2013
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 29327055

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abraxane and Paclitaxel in people with Breast Cancer, run by Fondazione Michelangelo at 67 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Spain, Italy, Germany, Australia, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic Complete Response (pCR) (time frame: At the time of surgery: 40 months after the randomization of the first patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01822314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

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