Cisplatin + RT for Triple Negative Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Triple negative, Stage II, Stage III
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
Sites / Locations
- Massachusetts General Hospital
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Dana-Farber at Milford
- Dana Farber at South Shore Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cisplatin + Radiation Therapy
Arm Description
Cisplatin concurrently with radiation therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Long term toxicity
To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
Full Information
NCT ID
NCT01674842
First Posted
August 23, 2012
Last Updated
August 23, 2021
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01674842
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
June 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Triple negative, Stage II, Stage III
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cisplatin + Radiation Therapy
Arm Type
Experimental
Arm Description
Cisplatin concurrently with radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Once daily, Monday - Friday for six weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
Intravenously, once weekly for six weeks
Primary Outcome Measure Information:
Title
Safety of Cisplatin w/ Radiation
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Local recurrence at 5 years
Description
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
Title
Long term toxicity
Description
To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer R Bellon, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber at Milford
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Dana Farber at South Shore Hospital
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33713742
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.
Results Reference
derived
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Cisplatin + RT for Triple Negative Breast Cancer
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