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
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring neoadjuvant therapy, drug therapy
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
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
NCT ID
NCT01270373
First Posted
January 4, 2011
Last Updated
February 12, 2020
Sponsor
Instituto Nacional de Cancer, Brazil
Collaborators
Sanofi
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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