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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
FAC x 3 followed by Docetaxel x 3
Docetaxel x 3 followed by FAC x 3
Sponsored by
Instituto Nacional de Cancer, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring neoadjuvant therapy, drug therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital do Cancer III

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FAC x 3 followed by Docetaxel x 3

Docetaxel x 3 followed by FAC x 3

Arm Description

Outcomes

Primary Outcome Measures

Pathological complete response

Secondary Outcome Measures

Cardiac toxicity

Full Information

First Posted
January 4, 2011
Last Updated
February 12, 2020
Sponsor
Instituto Nacional de Cancer, Brazil
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01270373
Brief Title
NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?
Acronym
NeoSAMBA
Official Title
Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancer, Brazil
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
neoadjuvant therapy, drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAC x 3 followed by Docetaxel x 3
Arm Type
Active Comparator
Arm Title
Docetaxel x 3 followed by FAC x 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FAC x 3 followed by Docetaxel x 3
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel x 3 followed by FAC x 3
Intervention Description
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
Primary Outcome Measure Information:
Title
Pathological complete response
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cardiac toxicity
Time Frame
5 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage IIB to IIIB HER-2 negative breast cancer ECOG performance status ≤ 2 Neuropathy grade <1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0) Adequate hematologic function with: Absolute neutrophil count (ANC) >1500/μL Platelets ≥100,000/μL Hemoglobin ≥ 9 g/dL 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 Adequate cardiac function Left ventricular ejection fraction (LVEF) within institutional normal range Knowledge of the investigational nature of the study and ability to provide consent for study participation Exclusion criteria Pregnancy Bilateral, synchronous breast cancer Previous diagnosis of breast or other cancer 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Bines, MD
Organizational Affiliation
INCA Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital do Cancer III
City
Rio de Janeiro
ZIP/Postal Code
20560-120
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32476183
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.
Results Reference
derived

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

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