Text Size

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: FAC x 3 followed by Docetaxel x 3
Drug: Docetaxel x 3 followed by FAC x 3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cancer, Brazil:

Primary Outcome Measures:
  • Pathological complete response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac toxicity [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FAC x 3 followed by Docetaxel x 3 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
Experimental: Docetaxel x 3 followed by FAC x 3 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

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270373

Locations
Brazil
Hospital do Cancer III
Rio de Janeiro, Brazil, 20560-120
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Sanofi
Investigators
Study Chair: Jose Bines, MD INCA Brazil
  More Information

No publications provided

Responsible Party: José Bines, MD, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT01270373     History of Changes
Other Study ID Numbers: Neo2010
Study First Received: January 4, 2011
Last Updated: March 18, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto Nacional de Cancer, Brazil:
neoadjuvant therapy
drug therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013