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NCT05296798 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Locally Advanced or Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 922
- Enrollment target
- 20
- Study locations
NCT05296798 is a Phase 3 study of Locally Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 922 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT05296798, a Phase 3 study of Locally Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 922 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 922 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
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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, categorized as Phase 3. 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 909 total studies on file at ClinicalTrials.gov.
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.
NCT05296798 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, Michigan, Washington.
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.
What interventions are being tested in trial NCT05296798?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Phesgo (DRUG), Giredestrant (DRUG), LHRH Agonist (DRUG).
Who is sponsoring clinical trial NCT05296798?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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