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A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Node Positive Breast Cancer

Thank you

Trial Information

A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer


Inclusion Criteria:



- Patient with histologically proven breast cancer

- Surgical resection performed with clear margins (R0 resection)

- At least 1 histologically proven involved axillary node

- ER + or ER-

- Interval between surgery (2nd surgical procedure in case of multiple procedures) and
randomization inferior to 60 days

- Aged over 18 years, and more than 10-year life expectancy

- ECOG performance status 0-1

- Signed informed consent form prior to randomization

Exclusion Criteria:

- Bilateral breast cancer

- Inflammatory breast cancer

- Personal history of breast cancer

- Immunohistochemical only node involvement

- Intraductal breast cancer

- Distant metastases

- Contraindication to any drug contained in the chemotherapy regimens

- Any serious active disease or co-morbid medical condition including recent history of
severe sepsis and digestive inflammatory disease

- Poor renal function (creatinin level > 120 micromol/L), poor hepatic function (total
bilirubin level > 1 UNL), transaminases > 2.5 UNL)

- Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L;
Hemoglobin < 10 G/dL

- Poor contractile cardiac function (LVEF < 50%)

- Coronary disease

- Any history of cancer during the last 5 years, with the exception of basal cell
carcinomas or stage 0 (in situ) cervical carcinoma

- Pregnancy or breast feeding

- Absence of contraception in non menopausal women

- Adult patient unable to give informed consent because of intellectual impairment

- Concomitant participation to another trial

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Pascal Piedbois, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Association Europeenne de Recherche en Oncologie

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AERO-B03

NCT ID:

NCT00189670

Start Date:

Completion Date:

Related Keywords:

  • Node Positive Breast Cancer
  • Breast Neoplasms

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