Description:
The purpose of this study is to determine the safety and effectiveness of a combination of
chemotherapy and radiotherapy in breast cancer patients after breast surgery.
Title
- Brief Title: Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
- Official Title: Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)
Clinical Trial IDs
- ORG STUDY ID:
10-01969
- NCT ID:
NCT01289353
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Carboplatin | Paraplatin | ChemoRT |
Purpose
The purpose of this study is to determine the safety and effectiveness of a combination of
chemotherapy and radiotherapy in breast cancer patients after breast surgery.
Detailed Description
Preliminary experience in the neo-adjuvant setting of Locally Advanced Breast Cancer (LABC)
has recently demonstrated that hormone receptors negative patients have approximately 50%
chance to achieve a pathological response after concurrent chemo-radiation. In a
multi-institutional collaboration of 105 patients it was found that triple negative (TN)
tumor carriers achieved pathological response in 54% of the cases and that the response
reflected on 5-year disease free survival and overall survival. Our group has speculated that
these effects on the risk of distant recurrence could depend on the recovery of antitumor
immunity among the patients achieving pathological response, after tumor cell death induced
by concurrent chemo-radiation.
The investigators are proposing a novel study that translates these findings to the adjuvant
setting of TN tumors. TN breast cancer is a more aggressive form of the disease often
coinciding with basal-like tumors. BRCA mutated-cancer is more frequently TN.
The current protocol converges the experience NYU has developed in accelerated prone breast
radiotherapy with encouraging finding from the use of concurrent chemoradiation in LABC.
The investigators will study the feasibility of combining weekly carboplatin with concurrent
3-weeks prone breast radiotherapy in the adjuvant setting of 35 women with TN tumors, after
segmental mastectomy and nodal assessment. Primary endpoint of the study is acute toxicity of
the combined regimen, with a target of < 25% of grade II-III dermatitis.
Trial Arms
Name | Type | Description | Interventions |
---|
ChemoRT | Experimental | Concurrent Carboplatin and Radiotherapy | |
Eligibility Criteria
Inclusion Criteria:
- Age older than 18
- Pre- or post-menopausal women with Stage I and II breast cancer, triple negative
tumors
- Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
- Status post segmental mastectomy, after sentinel node biopsy and/or axillary node
dissection (Tumors < 5 mm in size do not require nodal assessment) or after mastectomy
- No previous chemotherapy
- Patient needs to be able to understand and demonstrate willingness to sign a written
informed consent document
Exclusion Criteria:
- Previous radiation therapy to the ipsilateral breast
- Active connective tissue disorders, such as lupus or scleroderma
- Pregnant or lactating women
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT |
Time Frame: | 60 days post-RT |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) |
Time Frame: | 6 months to 5 year post-RT |
Safety Issue: | |
Description: | Acute Toxicities include all Grade 1 toxicities |
Measure: | Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT) |
Time Frame: | 6 months to 5 years post-RT |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | NYU Langone Health |
Trial Keywords
- triple negative
- breast cancer
- adjuvant therapy
- Carboplatin
- chemotherapy
- radiation therapy
- chemo-radiotherapy
- accelerated radiotherapy
Last Updated
January 12, 2021