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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Giredestrant
  • Drug: 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).

Recruiting Locations

Orange Coast Medical Center
Fountain Valley, California 92708-6728

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.