Clinical trial NCT01270373: NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?
Official title: Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: neoadjuvant therapy
drug therapy
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Sanofi
First posted: 2011-01-05
Enrollment: 112
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathological complete response
timeFrame: 6 months
Secondary outcomes:
measure: Cardiac toxicity
timeFrame: 5 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital do Cancer III
Study officials:
affiliation: INCA Brazil
name: Jose Bines, MD
role: STUDY_CHAIR
References:
citation: Bines J, Small IA, Sarmento R, Kestelman F, Silva S, Rodrigues FR, Faroni L, Goncalves A, Ebecken E, Maroun P, Millen E, Bonamino M. Does the Sequence of Anthracycline and Taxane Matter? The NeoSAMBA Trial. Oncologist. 2020 Sep;25(9):758-764. doi: 10.1634/theoncologist.2019-0805. Epub 2020 Jun 23.