This trial is active, not recruiting.

Condition breast cancer
Treatments carboplatin, 3d-rt or imrt
Phase phase 1/phase 2
Sponsor New York University School of Medicine
Start date December 2010
End date June 2015
Trial size 39 participants
Trial identifier NCT01289353, S10-01969


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Concurrent Carboplatin and Radiotherapy
carboplatin Paraplatin
IV, weekly for 6 weeks, AUC of 2.0
3d-rt or imrt
From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy

Primary Outcomes

The proportion of patients who experience grade II-III dermatitis within 60 days post radiation treatment
time frame: up to 60 days after the end of radiation treatment

Secondary Outcomes

Proportion of patients who experience acute toxicities
time frame: baseline, weekly during the 3-week radiation therapy, and 3 weeks after RT
proportion of patients who experience grade 2 or higher late toxicities after 60 days post radiation treatment
time frame: 60 days to 5 years post radiation treatment
recurrence free survival
time frame: every year post treatment up to 10 years
overall survival
time frame: every year post treatment up to 10 years
Quality of Life
time frame: at baseline, last week of RT, 45-60 days from RT start and 2 yrs

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)
Principal investigator Carmen Perez, MD
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 information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.