Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Carboplatin
Radiation: 3D-RT or IMRT

Registration Number: NCT01289353

Lead Sponsor: NYU Langone Health

Brief Summary: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 92

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ChemoRT	3D-RT or IMRT	Concurrent Carboplatin and Radiotherapy
ChemoRT	Carboplatin	Concurrent Carboplatin and Radiotherapy

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT	60 days post-RT

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)	6 months to 5 years post-RT
Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)	6 months to 5 year post-RT	Acute Toxicities include all Grade 1 toxicities