Spots Global Cancer Trial Database for Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
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Trial Identification
Brief Title: Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer
Official Title: A Feasibility Study of De-escalation of Chemotherapy in Patients With Early-Stage HER2 Positive Breast Cancer
Study ID: NCT04419181
Conditions
Study Description
Brief Summary: The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.
Detailed Description: Assess the feasibility of four cycles of neoadjuvant Docetaxel Carboplatin Trastuzumab and Pertuzumab (TCHP) in women with early-stage (local/locally advanced) HER2+ breast cancer with a selective escalation of targeted HER2 directed therapy in the high risk group in the adjuvant setting. Participants with any residual disease after four cycles of TCHP will receive Trastuzumab Emtansine (TDM1) plus Pertuzumab while those with complete pathological response will receive Trastuzumab in the adjuvant settings.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Rochester Medical Center, Rochester, New York, United States
Contact Details
Name: Ajay Dhakal, MBBS
Affiliation: University of Rochester
Role: PRINCIPAL_INVESTIGATOR
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