Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients who experience grade II-III dermatitis within 60 days post radiation treatment
up to 60 days after the end of radiation treatment
Silvia Formenti, MD
New York University School of Medicine
United States: Institutional Review Board
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