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

NCT01270373 | Unknown Phase 2

• 1 other identifier: Neo2010
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

neoadjuvant therapy; drug therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  6 months

Secondary Outcomes (1)

• Cardiac toxicity

  5 months

Study Arms (2)

FAC x 3 followed by Docetaxel x 3

ACTIVE COMPARATOR

Drug: FAC x 3 followed by Docetaxel x 3

Docetaxel x 3 followed by FAC x 3

EXPERIMENTAL

Drug: Docetaxel x 3 followed by FAC x 3

Interventions

FAC x 3 followed by Docetaxel x 3 DRUG

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

FAC x 3 followed by Docetaxel x 3

Docetaxel x 3 followed by FAC x 3 DRUG

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

Docetaxel x 3 followed by FAC x 3

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead
• Sanofi: collaborator

Study Sites (1)

Hospital do Cancer III

Rio de Janeiro, 20560-120, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32476183 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jose Bines, MD

  INCA Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: August 1, 2010
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

BR (1)