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

• Status: Recruiting
• Trial end date: 2028-09-23
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Latin American Cooperative Oncology Group
• Collaborator: Brazilian Breast Cancer Study Group (GBECAM)
• Treatments: Cyclophosphamide; Docetaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Female participants, with at least 18 years old on the day of signing the free and informed consent;

• Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative), according to TNM 8th edition; Histologically confirmed diagnosis of invasive breast carcinoma (with any histology), HER-2 negative;

• The participant (or legally acceptable representative, if applicable) provides written informed consent for the study;

• The participant must agree to use a contraceptive as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment;

• Have a functional capacity according to the Eastern Cooperative Oncology Group (ECOG) from 0 to 2. The evaluation of the ECOG must be carried out within 7 days before the inclusion date.

• Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment;

• Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study.

Exclusion Criteria:

• Individuals who do not meet the inclusion criteria above-mentioned.