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

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Inclusion Criteria:

- Female patients aged 18 years or older

- Histologically confirmed invasive unilateral breast cancer

- HER2-negative disease (defined as 0-1+ by immunohistochemistry or 2+ by
immunohistochemistry without HER2 amplification by either FISH, CISH, or other
amplification tests done locally)

- 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

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. Documentation of a negative pregnancy test must be
available for premenopausal women with intact reproductive organs and for women less
than one year after the last menstrual cycle

- 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

- Patients on therapy with a strong CYP3A4 inhibitor and on therapy with Warfarin

- 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

- Any of the following abnormal baseline hematological values:

1. Absolute Neutrophil Count (ANC) < 1.5 x 10^9/L

2. Platelet count < 100 x 10^9/L

3. Hemoglobin (Hb) < 10 g/dL

- Any of the following abnormal baseline laboratory tests

1. Serum total bilirubin > 1.5 x ULN (upper limit of normal) (except for patients
with clearly documented Gilbert's syndrome)

2. Alanine transaminase (ALT) or aspartate transaminase (AST)> 1.25 x ULN

3. Alkaline phosphatase > 2.5 x ULN

4. Serum creatinine > 1.5 x ULN

- Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or
multi-gated scintigraphic scan (MUGA)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic Complete Response (pCR)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Luca Gianni, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele Hospital, Milan


Italy: The Italian Medicines Agency

Study ID:




Start Date:

April 2013

Completion Date:

October 2025

Related Keywords:

  • Breast Cancer
  • breast
  • cancer
  • unilateral
  • non metastatic
  • HER2 negative
  • Breast Neoplasms