Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.
Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
Untreated, unilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed.
Tumor lesion in the breast must be measurable in two dimensions, preferably by sonography.
HR+/HER2+ disease with centrally confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value and TILs on core biopsy (target lesion). ER/PgR positive and HER2-positive is defined according to current ASCO/CAP guidelines. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy of target lesion has therefore to be sent to the GBG central pathology laboratory prior to randomization. In patients with multifocal or multicentric breast cancer, all non-target lesions must also be HR+/HER2+, as confirmed by local testing.
Patients with HER2-negative breast cancer and/or HER2-positive, HR-negative breast cancer.
Need of immediate neoadjuvant chemotherapy, e.g. inflammatory breast cancer.
Patients with definitive clinical or radiologic evidence of Stage IV cancer.
Excisional biopsy or lumpectomy and /or axillary lymph node dissection and/or sentinel lymph node biopsy performed prior to study entry (biopsy of clinical involved LN is warranted).
GBG Forschungs GmbH
Lead sponsor
Roche Pharma AG
Collaborator