Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

NCT ID: NCT06405295

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-06

Study Completion Date

2029-05-01

Brief Summary

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

Detailed Description

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Conditions

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Breast Carcinoma BRCA Mutation Adjuvant Drug Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Capecitabine

no intervention

Intervention Type OTHER

Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention

Olaparib

no intervention

Intervention Type OTHER

Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention

Capecitabine and Olaparib

no intervention

Intervention Type OTHER

Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention

Interventions

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no intervention

Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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PENG YUAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Yuan

Role: PRINCIPAL_INVESTIGATOR

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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NCC3896

Identifier Type: -

Identifier Source: org_study_id

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