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NCT05894239 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.

Recruiting
Registry status
Phase 3
Development phase
230
Enrollment target
20
Study locations

NCT05894239 is a Phase 3 study of Metastatic Breast Cancer that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 230 participants, above the 203-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT05894239, a Phase 3 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by Hoffmann-La Roche.

RECRUITING
Registry status
Phase 3
Development phase
230 participants
Enrollment target
20
Study locations

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

Metastatic Breast Cancer

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

909 total trials

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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, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 203-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (13% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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.

NCT05894239 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Texas, Washington.

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.

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).

Who is sponsoring clinical trial NCT05894239?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.