Recruiting
Phase 3

Giredestrant

Sponsor:

Genentech, Inc.

Code:

NCT07541079

Conditions

Early Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Giredestrant

Study Details

Brief summary:

The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.

Conditions

Early Breast Cancer

Study ID

NCT07541079

Start date

Aug 25, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2034

Anticipated

Primary completion date

Jun 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Considered appropriate for treatment with endocrine therapy (ET)
  • Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC)
  • Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive
  • Documented HER2- tumor according to ASCO/CAP
  • Postmenopausal females at the time of signing the Informed Consent Form
  • Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months
  • Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent
  • Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment
  • Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance
  • Participant and investigator planning the first switch from an AI
  • Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and/or axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB) and/or radiotherapy
  • Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1

Exclusion Criteria:

  • Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents
  • Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease
  • Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)
  • Have active cardiac disease or history of cardiac dysfunction
  • Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \[HBV\] or hepatitis C virus \[HCV\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
  • Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Giredestrant

Interventions

Giredestrant

Participants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

Primary outcome measure

  • Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months [ Time Frame: At 12 months ]
  • Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0) [ Time Frame: From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months) ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO46747 https://forpatients.roche.com/ No attachments to email below.

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

Locations

Orange Coast Medical Center

Recruiting

Fountain Valley, California, United States, 92708-6728

Cancer and Leukemia Center

Recruiting

Sterling Heights, Michigan, United States, 48314

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Estrogen receptor positive
  • ER+
  • Human epidermal growth factor receptor 2 negative
  • HER2-

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-01.