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

Study acronym: GeparPiPPa
StatusRecruiting
PhasePhase 2
Started2023-01-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 2026 → Jan 2027
See other at-risk trials from GBG Forschungs GmbH

Amendment history

2026-09-09
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v4
Trial sites expanded: 29 → 62 locations
Primary completion pushed: 2026-10 → 2027-01
Completion date2027-01→2027-03
2025-02-13
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations, IPDSharing v3
Study sites1→29
Eligibility criteria+270 characters
Inclusion Criteria: Written informed consent for all study procedures according [...] ncisional biopsy is not allowed. Tumor lesion in the breast with a palpable size of ≥ 2 cm or a sonographical size of ≥ 1 cm in maximum diameter. The lesion has tomust be measurable in two dimensions, preferably by sonography. Patients must be in the following stages of disease: • cT1ccT1b - cT3 regardless of nodal status In patients with multifocal or multicentric breast cancer t [...] sitive is defined according to current ASCO/CAP guidelines. PIK3CA mutational status will be determined by NGS. Formalin-fixed, paraffin-e [...] [...]
2024-02-21
Study Status v2
Re-verified, no change to tracked fields
2023-01-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03→2026-10
Completion date2026-06→2027-01
Start dateestimated 2022-06→confirmed 2023-01-02
Study sites0→1
2022-03-23
Original filing
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 Number NCT05306041
Lead Sponsor GBG Forschungs GmbH
Collaborators: Roche Pharma AG
Conditions HER2-positive Breast Cancer
Enrollment 170 participants
Start Date 2023-01-02
Primary Completion 2027-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-11