The NeoTHERa phase II randomized trial is actively enrolling patients with HER2-amplified/positive early breast cancer to compare pathological complete response rates between docetaxel/trastuzumab/pertuzumab (THP) and docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP) neoadjuvant regimens.
The University of Kansas Medical Center is conducting NeoTHERa, a randomized phase II trial evaluating whether the addition of carboplatin to a docetaxel, trastuzumab, and pertuzumab backbone improves pathological complete response (pCR) rates in the neoadjuvant setting for HER2-amplified or HER2-positive early breast cancer. The trial is currently recruiting.
The two arms under investigation—THP (docetaxel, trastuzumab, pertuzumab) and TCHP (docetaxel, carboplatin, trastuzumab, pertuzumab)—reflect an ongoing clinical question regarding the incremental benefit of platinum-based chemotherapy in HER2-targeted neoadjuvant regimens. Both trastuzumab and pertuzumab biosimilars are permitted, broadening eligibility and reflecting current formulary realities.
Achievement of pCR following neoadjuvant therapy in HER2-positive breast cancer is an established surrogate associated with improved event-free and overall survival. Defining whether carboplatin adds meaningful pCR benefit over a dual HER2 blockade backbone without platinum—while potentially increasing hematologic toxicity—has direct implications for treatment selection and de-escalation strategies in this population.
Key points
- NeoTHERa is a randomized phase II trial comparing THP versus TCHP as neoadjuvant therapy in HER2-amplified/positive early breast cancer
- Primary endpoint is pathological complete response (pCR) rate
- The trial directly addresses whether carboplatin adds benefit to dual HER2 blockade with trastuzumab and pertuzumab
- Biosimilars of trastuzumab and pertuzumab are permitted in both arms
- Trial is currently recruiting at the University of Kansas Medical Center (NCT07220135)
Why it matters
Determining whether carboplatin meaningfully increases pCR rates when added to docetaxel plus dual HER2 blockade could refine neoadjuvant regimen selection, balancing efficacy against platinum-associated toxicity in HER2-positive early breast cancer.