Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

NCT05894239 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Phesgo
  • DRUG Inavolisib
  • DRUG Taxane-based Chemotherapy
  • DRUG Optional Endocrine Therapy of Investigator's Choice

Study Locations (20)

California

  • Disney Family Cancer Center — Burbank
  • City of Hope — Corona
  • City of Hope Comprehensive Cancer Center — Duarte
  • City of Hope at Irvine Lennar — Irvine
  • Ellison Institute of Technology — Los Angeles

Texas

  • Renovatio Clinical - El Paso — El Paso
  • JPS Health Network — Fort Worth
  • Lumi Research — Kingwood
  • Renovatio Clinical — The Woodlands

Washington

  • Kadlec Clinic Hematology and Oncology — Kennewick
  • Swedish Medical Center — Seattle

Arizona

  • Banner Health MD Anderson AZ — Gilbert

District of Columbia

  • Georgetown Uni Hospital — Washington D.C.

Maryland

  • Medstar Research Institute — Hyattsville

Massachusetts

  • Dana Farber Cancer Institute — Boston

Michigan

  • Henry Ford Hospital — Detroit

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2023-09-08
Est. Completion 2032-12-28
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05894239

The ClinicalTrials.gov registry entry for NCT05894239 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05894239 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Texas, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05894239 about?

NCT05894239 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer". This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated ...

What is the current status of trial NCT05894239?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2023-09-08. Estimated completion is 2032-12-28.

What conditions does trial NCT05894239 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05894239?

The interventions under investigation include: Placebo (DRUG), Phesgo (DRUG), Inavolisib (DRUG), Taxane-based Chemotherapy (DRUG), Optional Endocrine Therapy of Investigator's Choice (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05894239?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05894239 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial