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

NCT04540692

Active Not RecruitingPhase 3

Sponsor: Latin American Cooperative Oncology Group

Conditions: Breast Cancer

Interventions: Docetaxel or Paclitaxel, Cyclophosphamide + Doxorrubicin

Countries: Brazil

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (16)
  • Cachoeiro de Itapemirim, Espírito Santo, Brazil
  • Salvador, Estado de Bahia, Brazil
  • Goiânia, Goiás, Brazil
  • Curitiba, Paraná, Brazil
  • Curitiba, Paraná, Brazil
  • Curitiba, Paraná, Brazil
  • Recife, Pernambuco, Brazil
  • Rio de Janeiro, Rio de Janeiro, Brazil
  • Volta Redonda, Rio de Janeiro, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Florianópolis, Santa Catarina, Brazil
  • Barretos, São Paulo, Brazil
  • Botucatu, São Paulo, Brazil
  • Campinas, São Paulo, Brazil
  • Jales, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil