Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments fac x 3 followed by docetaxel x 3, docetaxel x 3 followed by fac x 3
Phase phase 2
Sponsor Instituto Nacional de Cancer, Brazil
Collaborator Sanofi
Start date August 2010
End date December 2013
Trial size 112 participants
Trial identifier NCT01270373, Neo2010

Summary

The purpose of this study is to evaluate the usual and the reverse sequence of an anthracycline followed by a taxane in locally advanced breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
fac x 3 followed by docetaxel x 3
5-Fluorouracil (500 mg/m2), Adriamycin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles; followed by Docetaxel 100 mg/m2 every 21 days, for 3 cycles
(Experimental)
docetaxel x 3 followed by fac x 3
Docetaxel 100 mg/m2 IV every 21 days, for 3 cycles; followed by 5-Fluorouracil (500 mg/m2), Adriamycin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles

Primary Outcomes

Measure
Pathological complete response
time frame: 6 months

Secondary Outcomes

Measure
Cardiac toxicity
time frame: 5 months

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Instituto Nacional de Cancer, Brazil.