Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Carcinoma; Adjuvant Drug Therapy; BRCA Mutation
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Early-stage triple-negative breast cancer with BRCA1/2 mutations treated at multiple hospitals in China with postoperative sequential treatment with capecitabine or olaparib or a combination of both drugs

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Capecitabine	Other: no intervention; Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Olaparib	Other: no intervention; Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Capecitabine and Olaparib	Other: no intervention; Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
iDFS%	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
DRFS%	3 years
OS%	3 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Peng Yuan

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC3896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No