RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Quick Facts

Study Start:2023-12-11
Study Completion:2028-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06065748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  2. * Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
  3. * Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
  4. * Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of neo/adjuvant CDK4/6i is allowed.
  5. * No prior systemic anti-cancer therapy for advanced disease
  6. * Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
  7. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  8. * For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment
  1. * Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
  2. * Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
  3. * Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  4. * Active cardiac disease or history of cardiac dysfunction
  5. * Clinically significant history of liver disease

Contacts and Locations

Study Contact

Reference Study ID Number: CO44657 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Southern Cancer Center
Daphne, Alabama, 36526
United States
TOI Clinical Research
Cerritos, California, 90703
United States
Marin Cancer Care Inc
Greenbrae, California, 94904
United States
Kaiser Permanente - Harbor City
Harbor City, California, 90710
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
USC Norris Cancer Center; Oncology/Hematology - Newport Beach Treatment Center
Newport Beach, California, 92663
United States
Sutter Health Medical Center
Sacramento, California, 95816
United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, 90502
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
MedStar Washington Hosp Center
Washington, District of Columbia, 20010
United States
Florida Cancer Specialists - Fort Myers (Gladiolus Dr)
Fort Myers, Florida, 33908
United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
United States
SCRI Florida Cancer Specialists PAN
Tallahassee, Florida, 32308
United States
Florida Cancer Specialists - Tampa
Tampa, Florida, 33603
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30329
United States
Mission Cancer + Blood - IMMC
Des Moines, Iowa, 50309
United States
New England Cancer Specialists
Scarborough, Maine, 04074
United States
Maryland Oncology Hematology
Annapolis, Maryland, 21401
United States
Frederick Health Hospital
Frederick, Maryland, 21701
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816
United States
Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504-8332
United States
Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, 17604
United States
Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit
Philadelphia, Pennsylvania, 19106
United States
WellSpan Oncology Research
York, Pennsylvania, 17403
United States
Lifespan Cancer Institute
Providence, Rhode Island, 02905
United States
Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota, 57401
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
West Cancer Center
Germantown, Tennessee, 38138
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Texas Oncology Cancer Center
Austin, Texas, 78731
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11
Study Completion Date2028-12-30

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2028-12-30

Terms related to this study

Keywords Provided by Researchers

  • oral Selective Estrogen Receptor Degrader (SERD)
  • CDK4/6 inhibitor (CDK4/6i)
  • ESR1 mutation

Additional Relevant MeSH Terms

  • Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer