Enrolling by invitation NCT06405295
Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: no intervention.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, BRCA Mutation, Adjuvant Drug Therapy. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
Overview
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
Interventions
- Other no intervention
Observation of the prognosis of patients with different standard treatment protocols in the clinic without intervention
Primary outcome measures
- iDFS% [Time frame: 3 years]
Secondary outcome measures (2)
- DRFS% [Time frame: 3 years]
- OS% [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06405295 · NCC3896