Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
- Conditions
- Breast CarcinomaBRCA MutationAdjuvant Drug Therapy
- Registration Number
- NCT06405295
- Brief Summary
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 600
Inclusion Criteria
- ECOG score 0-1
- TNBC
- BRCA1/2 mutation
- No distant metastases assessed by imaging after surgical treatment
- Breast cancer that is non-pCR after neoadjuvant therapy, or postoperative pathology suggestive of ≥pT2, or ≥pN1
- Have completed postoperative adjuvant chemotherapy and/or radiotherapy
- No major organ dysfunction
Exclusion Criteria
- Patients who are unable to take oral medication, or who refuse this medication regimen
- Already enrolled in another study, or less than or equal to 4 weeks from discontinuation of another medication
- Presence of severe dysfunction of vital organs
- Patients with other malignancies (with the exception of cured non-melanoma skin cancers, carcinoma in situ of the cervix and other tumours that have been cured for at least 5 years)
- Acute infectious disease or active chronic infectious disease
- History of uncontrolled epilepsy, central nervous system disease or mental disorder
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iDFS% 3 years
- Secondary Outcome Measures
Name Time Method DRFS% 3 years OS% 3 years
Trial Locations
- Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences🇨🇳Beijing, Beijing, China