Clinical trial · Interventional
Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy
NCT06268327CI-TRIAL-00074159not yet recruitingPhase 2 / Phase 3ClinicalTrials.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)
In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine tablets | Drug | Capecitabine | ALIAS |
| Cisplatin injection and gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cisplatin and gemicitabine
- description
- patients with triple negative breast cancer will recieve adjuvant cisplatin and gemicitabine in non pathological complete response after neo-adjuvant standard chemotherapy with dose of cisplatin 70mg/m2 at day one and gemicitabine 1000mg/m2 day one and day eight every 21 day for six cycle
- interventionNames
- Drug: Cisplatin injection and gemcitabine
- type
- EXPERIMENTAL
- label
- capecitabine
- description
- patients with triple negative breast cancer will recieve adjuvant capecitabin in non pathological complete response after neo-adjuvant standard chemotherapy with dose of capecitabine 1000-1250 mg/m2 every 21 day for six cycle
- interventionNames
- Drug: Capecitabine tablets
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 20 years and older. * Patients with no clinical/radiologic distant metastasis. * Tumor type: Invasive ductal carcinoma or invaive lobular carcinoma. * Tumor subtype: triple negative * patients had operable, primary invasive, noninflammatory early stage I-IIIB TNBC (ER and PR \<1%, HER2 score: 0 or 1) * Patients with a good performance status (0/1) * Patients with adequate hematological, cardiac, renal, and hepatic function Exclusion Criteria: * Patients who achieve pathologic complete response after neoadjuvant chemotherapy * inflammatory breast cancer * Breast cancer patients with distant metastasis * Patient with hormonal receptor positive /HER2 +ve
References
Publications (0)
Data not yet available
No reference posted for this study.