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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLatin American Cooperative Oncology Group

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Docetaxel or Paclitaxel
  • Cyclophosphamide + Doxorrubicin

Treatment groups

444 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Latin American Cooperative Oncology Group

Lead sponsor

Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

Collaborator