RecruitingPhase 3NCT04540692
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
NEOSAMBA Clinical Trial - Stage I
Sponsor
Latin American Cooperative Oncology Group
Enrollment
444 participants
Start Date
Jan 12, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria7
- 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.
Interventions
DRUGDocetaxel 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
DRUGCyclophosphamide + Doxorrubicin
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT04540692
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