A Phase 1 interventional study of Radiation Therapy and Cisplatin in Breast Cancer, sponsored by Dana-Farber Cancer Institute. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment
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
This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 55 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cisplatin concurrently with radiation therapy
Radiation: Radiation Therapy · Drug: Cisplatin
Once daily, Monday - Friday for six weeks
Intravenously, once weekly for six weeks
Also known as: CDDP
Safety of Cisplatin w/ Radiation
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.
Time frame: 2 years
Local recurrence at 5 years
To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.
Time frame: 5 years
Long term toxicity
To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
Time frame: 2 years
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Dana-Farber Cancer Institute