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

February 12, 2020 updated by: José Bines, Instituto Nacional de Cancer, Brazil

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20560-120
        • Hospital do Cancer III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FAC x 3 followed by Docetaxel x 3
Drug: FAC x 3 followed by Docetaxel x 3
5-Fluorouracil (500 mg/m2), Doxorubicin (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), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete response
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac toxicity
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Collaborators

Sanofi

Investigators

  • Study Chair: Jose Bines, MD, INCA Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

January 4, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neo2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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