Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

February 12, 2025 updated by: PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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%
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Peng Yuan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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