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Active, not recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT05296798

Public ClinicalTrials.gov record NCT05296798. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 5:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05296798
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
922 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 18, 2022 (Actual)
Primary completion
Jun 15, 2028 (Estimated)
Completion
Dec 31, 2030 (Estimated)
Last update posted
Oct 2, 2026

2022 – 2030

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Arizona Clinical Research Center, Inc Tucson Arizona 85715 —
Los Angeles Hematology Oncology Medical Group Los Angeles California 90017 —
Cancer Specialists of North Florida Jacksonville Florida 32256 —
Maryland Oncology Hematology - Annapolis Annapolis Maryland 21401 —
West Cancer Center Germantown Tennessee 38138 —
Texas Oncology - DFW Dallas Texas 75246 —
Texas Oncology - El Paso El Paso Texas 79902 —
Swedish Cancer Institute - Edmonds Campus Edmonds Washington 98026 —
Swedish Cancer Institute - Issaquah Issaquah Washington 98029 —
Swedish Cancer Institute Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 188 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05296798, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 2, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05296798 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →