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RECRUITING Phase 3

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

NCT06065748 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Interventions

  • DRUG Fulvestrant
  • DRUG Palbociclib
  • DRUG Abemaciclib
  • DRUG Ribociclib
  • DRUG Giredestrant

Study Locations (20)

California

  • Sutter Auburn Faith Hospital — Auburn
  • La Hematology Oncology Medical Group — Glendale
  • Marin Cancer Care Inc — Greenbrae
  • Kaiser Permanente - Harbor City — Harbor City
  • USC Norris Comprehensive Cancer Center — Los Angeles
  • USC Norris Cancer Center — Newport Beach
  • Sutter Medical Group, Roseville Clinic — Roseville
  • Sutter Health Medical Center — Sacramento
  • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente — Torrance

Florida

  • AdventHealth Altamonte — Altamonte Springs
  • Florida Cancer Specialists - Broadway — Fort Myers
  • Cancer Specialists of North Florida — Jacksonville
  • Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg) — St. Petersburg
  • Comprehensive Hematology Oncology — St. Petersburg
  • Florida Cancer Specialists - EAST - SCRI - PPDS — West Palm Beach

District of Columbia

  • Georgetown University Medical Center — Washington D.C.
  • MedStar Washington Hosp Center — Washington D.C.

Alabama

  • Southern Cancer Center — Daphne

Colorado

  • Rocky Mountain Cancer Centers — Littleton

Georgia

  • Grady Health System — Atlanta

Trial Details

FieldValue
Enrollment Target 1,050 participants
Start Date 2023-12-11
Est. Completion 2029-02-12
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 NCT06065748

The ClinicalTrials.gov registry entry for NCT06065748 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 1,050 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 Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Fulvestrant 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: NCT06065748 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, District of Columbia. 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 NCT06065748 about?

NCT06065748 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)". This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen recepto...

What is the current status of trial NCT06065748?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,050 participants. The study started on 2023-12-11. Estimated completion is 2029-02-12.

What conditions does trial NCT06065748 study?

This clinical trial studies the following conditions: Estrogen Receptor-Positive, HER2-Negative Advanced 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 NCT06065748?

The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), Giredestrant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06065748?

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 NCT06065748 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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