Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
NCT ID: NCT06405295
Last Updated: 2025-02-14
Study Results
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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ENROLLING_BY_INVITATION
600 participants
OBSERVATIONAL
2024-05-06
2029-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Capecitabine
no intervention
Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Olaparib
no intervention
Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Capecitabine and Olaparib
no intervention
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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PENG YUAN
Professor
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
Countries
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Other Identifiers
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NCC3896
Identifier Type: -
Identifier Source: org_study_id
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