Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/28/2018 |
| Start Date: | December 2010 |
| End Date: | December 2020 |
Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)
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.
chemotherapy and radiotherapy in breast cancer patients after breast surgery.
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.
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.
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
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