Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Adjuvant Drug Therapy; BRCA Mutation; Breast Carcinoma

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06405295

NCC3896

Details and patient eligibility

About

Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 3 patient groups

Capecitabine

Treatment:

Other: no intervention

Olaparib

Treatment:

Other: no intervention

Capecitabine and Olaparib

Treatment:

Other: no intervention