Adjuvant Drug Therapy, BRCA Mutation, Breast Carcinoma
Conditions
Brief summary
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
Interventions
OTHERno intervention
Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iDFS% | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| DRFS% | 3 years |
| OS% | 3 years |
Countries
China
Outcome results
None listed