Clinical trial · Interventional
Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy
A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide
- 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)
Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC4-CDDP4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- adriamycin,cytoxan, cisplatin
- description
- 4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks followed by 4 cycles of cisplatin 75 mg/m2 every 3 weeks
- interventionNames
- Drug: AC4-CDDP4
Primary outcomes (1)
- measure
- pathologic complete response (pCR) rate
- timeFrame
- up to 36 weeks
- description
- Rate of pCR (as defined by NSABP \[National Surgical Adjuvant Breast and Bowel Project\] criteria - absence of invasive disease in the breast \[ypT0\]) at the time of surgery.
Secondary outcomes (4)
- measure
- Overall response rate (ORR) by radiologic evaluation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven breast cancer 2. Age, at least 20 years 3. ER/PR/HER2 (negative/negative/negative * ER/PR negative: nuclear reaction \< 1%, Allred score 0 or 2 * HER2 negative: HER2; IHC (immunohistochemistry) 0,1+ or FISH/SISH (-) in case of IHC 2+ 4. Clinically stage II or III with histologically proven lymph-node involvement (T \>1.5 cm or lymph node \[LN\] \>1.5 cm) 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. No prior hormonal treatment, chemotherapy or radiotherapy is allowed. 7. Adequate hematologic, liver and kidney function 8. Written informed consent Exclusion Criteria: 1. Pregnancy or lactation 2. Prior chemotherapy or radiotherapy for any malignancy 3. Stage T4d; inflammatory breast cancer 4. No primary tumor (T0) 5. Documented history of cardiac disease contraindicating anthracyclines 6. Currently active infection
References
Publications (0)
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