Recruiting

Phase 3

GiredestrantA 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

Sponsor:

Hoffmann-La Roche

Code:

NCT07827573

Conditions

Early Breast Cancer

Estrogen Receptor-Positive Breast Cancer

HER2-Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Giredestrant

Study Details

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

Study ID

NCT07827573

Start date

Dec 11, 2026

Status verified date

Oct, 2026

Completion date

Nov 30, 2032

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: Upfront Adjuvant Endocrine Therapy Population

Participants will receive giredestrant.

experimental: Cohort B: Switch Adjuvant Endocrine Therapy Population

Participants will receive giredestrant.

Interventions

Giredestrant

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

Primary outcome measure

Incidence of Participants who Have Discontinued Giredestrant for any Reason [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

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

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

Locations

CHU de Québec - Hôpital du Saint-Sacrement

Recruiting

Québec, Quebec, Canada, G1S 4L8

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.