NCT04540692

Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer

NEOSAMBA Clinical Trial - Stage I

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Latin American Cooperative Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Detailed description

Multicenter, phase III, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. The treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. The chemotherapy regimen will follow the institution's routine, which includes the use of CA in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. The rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel or Paclitaxel	Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
DRUG	Cyclophosphamide + Doxorrubicin	Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles

Timeline

• Start date: 2021-01-12
• Primary completion: 2026-04-01
• Completion: 2030-08-01
• First posted: 2020-09-07
• Last updated: 2024-06-04

Locations

18 sites across 1 country: Brazil