NCT01270373

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

Randomized Phase II Trial of the Sequences of Anthracyline and Taxane in Locally Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Instituto Nacional de Cancer, Brazil · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2020-04-01
• Completion: 2020-06-01
• First posted: 2011-01-05
• Last updated: 2020-02-17

Locations

1 site across 1 country: Brazil