Clinical trial · Interventional
Cisplatin + RT for Triple Negative Breast Cancer
A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
- 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)
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy
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 |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin + Radiation Therapy
- description
- Cisplatin concurrently with radiation therapy
- interventionNames
- Radiation: Radiation Therapy
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Safety of Cisplatin w/ Radiation
- timeFrame
- 2 years
- description
- To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.
Secondary outcomes (2)
- measure
- Local recurrence at 5 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary tumor is triple negative breast cancer * Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins * Pathologic or clinical stage II or III disease * At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks) Exclusion Criteria: * Pregnant or breastfeeding * Prior radiation to breast or ipsilateral regional nodes * Ongoing therapy with other investigational agents * Hormonal therapy * Significant co-morbidity * Pathologic complete response following preoperative chemotherapy * Biopsy proven metastatic disease
References
Publications (1)
- DERIVEDBellon JR, Chen YH, Rees R, Taghian AG, Wong JS, Punglia RS, Shiloh RY, Warren LEG, Krishnan MS, Phillips J, Pretz J, Jimenez R, Macausland S, Pashtan I, Andrews C, Isakoff SJ, Winer EP, Tolaney SM. A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer. Int J Radiat Oncol Biol Phys. 2021 Sep 1;111(1):45-52. doi: 10.1016/j.ijrobp.2021.03.002. Epub 2021 Mar 10. PMID 33713742