Phase II Study of Early Clinical Response to Predict Surgery Outcome in Early Stage Breast Cancer Receiving Neoadjuvant Chemotherapy

What this Trial Is About

Researchers are studying whether the amount a breast tumor shrinks during chemotherapy before surgery can predict the amount of tumor left at surgery in patients with early breast cancer. This study focuses on three breast cancer subtypes triple-negative breast cancer TNBC, HER2-positive, and high-risk estrogen receptor-positive breast cancer. The goal is to find early signs of how well the tumor responds to treatment to help tailor therapy in the future and avoid ineffective treatments. Participants receive standard chemotherapy regimens over about 20 weeks, including combinations of drugs such as paclitaxel, carboplatin, doxorubicin, cyclophosphamide, trastuzumab, pertuzumab, and pembrolizumab depending on cancer subtype. Some participants with TNBC will have extra research procedures like biopsies and MRI scans before and after the first cycle of treatment to study tumor changes. Treatment includes four cycles of one drug combination followed by four cycles of another. Participants will have tumor size measured by imaging and physical exam at baseline and after treatment cycles to track response. Surgery is performed after treatment to assess the remaining tumor. Researchers will compare early tumor shrinkage to the final pathological response at surgery. Safety, organ function, and heart health are monitored throughout. The study duration is about 20 weeks until surgery, with assessments planned to evaluate how early clinical changes relate to final outcomes.

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer