Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

• Conditions: Breast Carcinoma; BRCA Mutation; Adjuvant Drug Therapy
• Interventions: Other: no intervention

• Registration Number: NCT06405295
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Study Start: 2024-05-06
• Study First Posted: 2024-05-08
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2029-03-01
• Study Completion: 2029-05-01

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

Arm && Interventions

Group	Intervention	Description
Capecitabine	no intervention	-
Olaparib	no intervention	-
Capecitabine and Olaparib	no intervention	-

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