Clinical trial · Observational
Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
A Multicentre Prospective Cohort Study: Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation
NCT06405295CI-TRIAL-00086018enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Drug Therapy | — | UNRESOLVED | — |
| BRCA Mutation | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Capecitabine
- interventionNames
- Other: no intervention
- label
- Olaparib
- interventionNames
- Other: no intervention
- label
- Capecitabine and Olaparib
- interventionNames
- Other: no intervention
Primary outcomes (1)
- measure
- iDFS%
- timeFrame
- 3 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.