This phase II trial compares the use of trastuzumab, pertuzumab and docetaxel (THP) to trastuzumab, pertuzumab, docetaxel and carboplatin (TCHP) for the treatment of stage II-III, HER2 positive breast cancer. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some tumor cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. THP may be as effective as TCHP for the treatment of stage II-III HER2 positive breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT07220135.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer CenterStatus: Active
Contact: Yiduo Hu
Phone: 913-588-6029
PRIMARY OBJECTIVE:
I. To evaluate the pathologic complete response (pCR) rate with two neoadjuvant regimens (docetaxel + carboplatin + trastuzumab (H)/pertuzumab (P) and docetaxel +H/P) in HER2 positive breast cancer.
SECONDARY OBJECTIVES:
I. Determine residual cancer burden (RCB) 0+1 rate.
II. Assess the toxicity and tolerability of each regimen.
III. Assess pCR and RCB by HER2DX pCR score status.
IV. 3- and 5-year recurrence-free, event-free, and overall survival (to be completed with the PRO-HER2 registry study).
EXPLORATORY OBJECTIVES:
I. Correlation of imaging response with pathologic response.
II. Blood/plasma/tissue collection for future correlative studies.
III. Correlation of HER2DX test scores and other tissue and blood biomarkers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive carboplatin intravenously (IV), docetaxel IV, trastuzumab IV or subcutaneously (SC) and pertuzumab IV or SC on day 1 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography or multigated acquisition (MUGA) scan and mammogram during screening, as well as magnetic resonance imaging (MRI) or ultrasound and blood sample collection throughout the study.
ARM B: Patients receive docetaxel IV, trastuzumab IV or SC and pertuzumab IV or SC on day 1 of each cycle. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography or MUGA scan and mammogram during screening, as well as MRI or ultrasound and blood sample collection throughout the study.
After completion of study intervention and all local and systemic treatment for breast cancer (surgery, chemotherapy, or radiation, whichever comes last), patients are followed up every 6 months until 5 years post-diagnosis.
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorYiduo Hu
