NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?
This trial is active, not recruiting.
|Treatments||fac x 3 followed by docetaxel x 3, docetaxel x 3 followed by fac x 3|
|Sponsor||Instituto Nacional de Cancer, Brazil|
|Start date||August 2010|
|End date||December 2013|
|Trial size||112 participants|
|Trial identifier||NCT01270373, Neo2010|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Pathological complete response
time frame: 6 months
time frame: 5 months
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
|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.|
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