MedTrace Logo

A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC

NCT07245797 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-11-24

No results posted yet for this study

Summary

The study consists of a screening period of 28 days, a treatment period. Local or central testing of PIK3CA mutation in blood or tumor tissue must be performed using an approved polymerase chain reaction (PCR)-based or next generation sequencing (NGS) assay at a clinical laboratory. Patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 1:1 ratio to receive:

Neoadjuvant treatment with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous (PH-FDC SC) formulation q3w and nab-paclitaxel (125 mg/m2 on days 1, 8, and 15) in 3-week cycle for total 6 cycles

* with inavolisib (6 cycles) or
* without inavolisib. 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

Interventions

DRUG

fixed-dose combination of pertuzumab and trastuzumab as subcutaneousformulation q3w and nab-paclitaxel in 3-week cycle for total 6 cycles with inavolisib (6 cycles) or without inavolisib.

fixed-dose combination of pertuzumab and trastuzumab as subcutaneousformulation q3w and nab-paclitaxel in 3-week cycle for total 6 cycles with inavolisib (6 cycles) or without inavolisib.

Sponsors & Collaborators

  • Zhimin Shao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-12-15
Completion
2027-02-23

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 NCT07245797 on ClinicalTrials.gov