NCT05306041

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

A Randomized, Open-label, Phase II Trial Comparing Neoadjuvant Endocrine Therapy in Combination with Trastuzumab, Pertuzumab +/- the PI3K Inhibitor Inavolisib in Patients with HER2-positive, HR-positive, PIK3CA Mutant Early Breast Cancer-GeparPiPPa

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, prospective, randomized, open-label, parallel-group, phase II study to evaluate the potential incremental efficacy and safety of inavolisib in the neoadjuvant treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer. 170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive: Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w for 6 cycles (18 weeks) with (6cycles) or without inavolisib. Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men. In both study arms, treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient. All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Inavolisib	daily application of 9 mg (may be decreased to 6 mg and to 3 mg)
DRUG	PHESGO	fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase s.c. (PH-FDC SC) q3w beginning on day 1 of cycle 1 for 6 cycles (18 weeks)
DRUG	Endocrine therapy	Endocrine therapy per physician´s choice with either tamoxifen 20mg or an aromatase inhibitor +/- GnRH analogue for premenopausal women and men

Timeline

• Start date: 2023-01-02
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2022-03-31
• Last updated: 2025-02-17

Locations

29 sites across 2 countries: Germany, Italy