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ACTIVE NOT RECRUITING Phase 3

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

NCT05296798 · View on ClinicalTrials.gov ↗

Study Summary

This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.

Interventions

  • DRUG Docetaxel
  • DRUG Paclitaxel
  • DRUG Phesgo
  • DRUG Giredestrant
  • DRUG LHRH Agonist

Study Locations (20)

Texas

  • CHRISTUS Spohn Cancer Center - Shoreline — Corpus Christi
  • Texas Oncology - DFW — Dallas
  • Texas Oncology - El Paso — El Paso
  • CHRISTUS St. Michael Health System — Texarkana

Michigan

  • St. Joseph Mercy Hospital — Ann Arbor
  • Henry Ford Hospital — Detroit
  • St. Joseph Mercy Oakland — Pontiac

Washington

  • Swedish Cancer Institute - Edmonds Campus — Edmonds
  • Swedish Cancer Institute - Issaquah — Issaquah
  • Swedish Cancer Institute — Seattle

New York

  • Queens Hospital Cancer Center — Jamaica
  • Clinical Research Alliance — Westbury

Arizona

  • Arizona Clinical Research Center, Inc — Tucson

California

  • Los Angeles Hematology Oncology Medical Group — Los Angeles

Florida

  • Cancer Specialists of North Florida — Jacksonville

Illinois

  • Carle Cancer Center — Urbana

Trial Details

FieldValue
Enrollment Target 922 participants
Start Date 2022-07-18
Est. Completion 2030-12-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05296798

The ClinicalTrials.gov registry entry for NCT05296798 describes a study currently listed as active not 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 922 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 Locally Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel 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: NCT05296798 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, Michigan, 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 NCT05296798 about?

NCT05296798 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)". This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (...

What is the current status of trial NCT05296798?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 922 participants. The study started on 2022-07-18. Estimated completion is 2030-12-31.

What conditions does trial NCT05296798 study?

This clinical trial studies the following conditions: Locally Advanced or 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 NCT05296798?

The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Phesgo (DRUG), Giredestrant (DRUG), LHRH Agonist (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05296798?

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 NCT05296798 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. 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