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

NCT01270373 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-02-17

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Jose Bines, MD · INCA Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2020-04-30
Completion
2020-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01270373 on ClinicalTrials.gov