MedTrace Logo

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

NCT05306041 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Mattea Reinisch, PD Dr. med. · Universitätsmedizin Mannheim, Frauenklinik mit Brustzentrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306041 on ClinicalTrials.gov