A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment

NCT07827573 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: BO467752026-526742-27-00
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant. The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.

Conditions

Early Breast Cancer; Estrogen Receptor-Positive Breast Cancer; HER2-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Participants who Have Discontinued Giredestrant for any Reason

  Month 12

Secondary Outcomes (39)

• Incidence and Severity of Adverse Events (AEs)

  Up to approximately 5 years

• Treatment Adherence, as Measured by Dose Intensity

  Up to approximately 5 years

• Treatment Adherence, as Measured by Treatment Duration

  Up to approximately 5 years

• Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)

  At prespecified timepoints from Baseline until approximately 5 years

• Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES

  At prespecified timepoints from Baseline until approximately 5 years

Study Arms (2)

Cohort A: Upfront Adjuvant Endocrine Therapy Population

EXPERIMENTAL

Participants will receive giredestrant.

Drug: Giredestrant

Cohort B: Switch Adjuvant Endocrine Therapy Population

EXPERIMENTAL

Participants will receive giredestrant.

Drug: Giredestrant

Interventions

Giredestrant DRUG

Participants will receive giredestrant 30 mg orally once a day for up to 5 years.

Also known as: RO7197597, GDC-9545, RG6171

Cohort A: Upfront Adjuvant Endocrine Therapy Population; Cohort B: Switch Adjuvant Endocrine Therapy Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer
• Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy)
• Participants must have completed any prior adjuvant chemotherapy before enrollment, if given
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
• Adequate organ function
• Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist

You may not qualify if:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
• Diagnosis of inoperable locally advanced or Stage IV breast cancer
• History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
• Planned surgery during the study
• Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents
• Active cardiac disease or history of cardiac dysfunction

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

giredestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2032
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share