NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
José Bines, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier:
NCT01270373
First received: January 4, 2011
Last updated: March 18, 2013
Last verified: March 2013

January 4, 2011
March 18, 2013
August 2010
December 2013   (final data collection date for primary outcome measure)
Pathological complete response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Pathological complete response [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01270373 on ClinicalTrials.gov Archive Site
Cardiac toxicity [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Dose intensity [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Cardiac toxicity [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?
Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: 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
  • Drug: 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
  • Active Comparator: FAC x 3 followed by Docetaxel x 3
    Intervention: Drug: FAC x 3 followed by Docetaxel x 3
  • Experimental: Docetaxel x 3 followed by FAC x 3
    Intervention: Drug: Docetaxel x 3 followed by FAC x 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
112
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01270373
Neo2010
No
José Bines, Instituto Nacional de Cancer, Brazil
Instituto Nacional de Cancer, Brazil
Sanofi
Study Chair: Jose Bines, MD INCA Brazil
Instituto Nacional de Cancer, Brazil
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP