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Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer

Phase 2
Open (Enrolling)
Breast Cancer

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Trial Information

Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer

Anthracylines and taxanes are the most active chemotherapy agents in the treatment of breast
cancer. The usual sequence of an anthracycline followed by a taxane is due to the timing of
their discovery and introduction in the treatment armamentarium. More recent evidence
suggests that there is pre clinical as well as clinical rational for the reverse sequence.

The neoadjuvant approach allows quick evaluation of these different treatment strategies. At
the same time, the study will collect tissue biopsies and blood at different time points in
order to evaluate predictive biomarkers.

Inclusion Criteria:

1. Stage IIB to IIIB HER-2 negative breast cancer

2. ECOG performance status ≤ 2

3. Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0
(CTCAE v 3.0)

4. Adequate hematologic function with:

- Absolute neutrophil count (ANC) >1500/μL

- Platelets ≥100,000/μL

- Hemoglobin ≥ 9 g/dL

5. Adequate hepatic and renal function with:

- Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x
institutional ULN

- Alkaline phosphatase ≤2.5 x institutional ULN

- Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min

6. Adequate cardiac function

- Left ventricular ejection fraction (LVEF) within institutional normal range

7. Knowledge of the investigational nature of the study and ability to provide consent
for study participation

Exclusion criteria

1. Pregnancy

2. Bilateral, synchronous breast cancer

3. Previous diagnosis of breast or other cancer

4. Any other disease(s), psychiatric condition, metabolic dysfunction, that
contraindicates the use of study drugs or that would make the patient inappropriate
for this study

Type of Study:


Study Design:

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

Outcome Measure:

Pathological complete response

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jose Bines, MD

Investigator Role:

Study Chair

Investigator Affiliation:

INCA Brazil


Brazil: Ministry of Health

Study ID:




Start Date:

August 2010

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • neoadjuvant therapy
  • drug therapy
  • Breast Neoplasms