Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

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.

Trial Details

NCT ID
NCT05306041
Phase
PHASE2
Sponsor
GBG Forschungs GmbH
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Inavolisib
  • PHESGO
  • Endocrine therapy
Locations (sample)
  • Essen, North Rhine-Westphalia, Germany|51.45657,7.01228
  • Augsburg, Germany|48.37154,10.89851
  • Berlin, Germany|52.52437,13.41053
  • Berlin, Germany|52.52437,13.41053
  • Bielefeld, Germany|52.03333,8.53333

Key Eligibility Criteria

  • 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. Inc…
  • Tumor lesion in the breast must be measurable in two dimensions, preferably by sonography.
  • Patients must be in the following stages of disease:

For full eligibility, visit ClinicalTrials.gov.

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