Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
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.
Radiation: 3D-RT or IMRT
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)|
- 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 ] [ Designated as safety issue: Yes ]
- Proportion of patients who experience acute toxicities [ Time Frame: baseline, weekly during the 3-week radiation therapy, and 3 weeks after RT ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- recurrence free survival [ Time Frame: every year post treatment up to 10 years ] [ Designated as safety issue: No ]This is an exploratory outcome
- overall survival [ Time Frame: every year post treatment up to 10 years ] [ Designated as safety issue: No ]This is an exploratory outcome
- Quality of Life [ Time Frame: at baseline, last week of RT, 45-60 days from RT start and 2 yrs ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2021|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Concurrent Carboplatin and Radiotherapy
IV, weekly for 6 weeks, AUC of 2.0
Other Name: ParaplatinRadiation: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289353
|Contact: Silvia Formenti, MDfirstname.lastname@example.org|
|Contact: Ravindran Kathirithamby||212-731-5335||Ravindran.Kathirithamby@nyumc.org|
|United States, New York|
|NYU Cancer Center||Recruiting|
|New York, New York, United States, 10016|
|Principal Investigator: Yelena Novik, MD|
|Principal Investigator: Silvia Formenti, MD|
|Sub-Investigator: James Speyer, MD|
|Sub-Investigator: Sylvia Adams, MD|
|Sub-Investigator: Stella Lymberis, MD|
|Sub-Investigator: Nelly Huppert, MD|
|Sub-Investigator: Brian Yeh, M.D.|
|Principal Investigator:||Silvia Formenti, MD||New York University School of Medicine|