Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Observational
Started
2024-05-06
Last updated
2025-02-14
Condition(s) studied
Breast CarcinomaBRCA MutationAdjuvant Drug Therapy
Investigational drug(s) / intervention(s)
no intervention
no intervention: Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Study summary
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
iDFS% — 3 years
Trial sites (1)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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