Clinical trial NCT01674842: Cisplatin + RT for Triple Negative Breast Cancer
Official title: A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Triple negative
Stage II
Stage III
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of Cisplatin w/ Radiation
timeFrame: 2 years
Secondary outcomes:
measure: Local recurrence at 5 years
timeFrame: 5 years
measure: Long term toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber at Milford
state: Massachusetts
city: Weymouth
country: United States
facility: Dana Farber at South Shore Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer R Bellon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellon 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.