Clinical trial · Interventional
Decitabine Plus Carboplatin in the Treatment of Metastatic TNBC
Decitabine Plus Carboplatin in the Treatment of Metastatic Triple Negative Breast Cancer
NCT03295552CI-TRIAL-00057581DETECTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment.
Summary
Brief summary (as posted)
To evaluate the effect of novel DNA demethylating agents in the treatment of metastatic TNBC
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DC
- description
- DNA demethylating agent decitabine plus carboplatin
- interventionNames
- Drug: Decitabine
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- At the end of Cycle 6 (each cycle is 21 days)
- description
- Partial response (PR) + complete response (CR) rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female aged between 18 years and 70 years old. * Pathologically confirmed metastatic triple negative breast cancer (TNBC). Paraffin-embedded tissue were available from metastatic or primary sites to confirm its TNBC status or for further translational research. TNBC was defined as ER-, PR-, and HER2-. * Metastatic TNBC should not be treated with more than 1-line for metastatic disease. * Patients can not be treated with carboplatin in the metastatic setting. * For patients received carboplatin treatment in the adjuvant setting, they should have at least one year disease interval between last dosage of carboplatin and trial recruiting. * Patients had at least one measurable lesion according to RECIST criteria version 1.1. * ECOG Performance Status (PS) of 0-1. * Adequate liver and renal organ function. * Dated and signed IEC/IRB-approved informed consent. Exclusion Criteria: * More than 1 one therapy for metastatic TNBC, Patients may receive bisphosphonates and other therapies to treat bone metastases. * Less than four weeks since last radiotherapy. * Pregnancy or lactation or unwillingness to use adequate method of birth control. * Active or uncontrolled infection. * Hypersensitivity to carboplatin or decitabine * Male breast cancer. * Treated with any DNA demethylating agents * Young patients with pregnancy or lactation or unwillingness to use adequate method of birth control.
References
Publications (0)
Data not yet available
No reference posted for this study.