Clin2
NCT05306041Possibly a fitRecruiting

Pre-surgery hormone therapy with or without PI3K inhibitor

HER2-positive Breast Cancer

Treatments studied

Part of Cancer clinical trials.

This trial tests whether giving hormone-blocking treatment before surgery works better when combined with an added targeted drug for certain breast cancers. It may help shrink the tumor and improve outcomes for people whose tumors have specific hormone and genetic features.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
170 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have a new, untreated breast tumor on one side that was confirmed by core biopsy (not fine-needle aspiration).
  • Your tumor can be measured on scans, and it is in a certain early stage (cT1b to cT3) regardless of lymph node status.
  • Your tumor is ER-positive and HER2-positive, and it has a PIK3CA mutation confirmed by a central lab; testing also checks PR, Ki-67, and tumor-infiltrating lymphocytes.
  • You must be able to have heart tests (ECG and heart ultrasound) showing good heart pumping (LVEF above 55%) within 3 months.
  • Your blood counts and liver function must meet lab limits, and your HbA1c must be under 6.5% (blood sugar control).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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