Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Instituto Nacional de Cancer, Brazil
With
Sanofi
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.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?
