Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer

NCT07643831 | Unknown

• 1 other identifier: AL46901
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this expanded access program (EAP) is to provide early access to giredestrant for participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC) or locally advanced/metastatic breast cancer (LA/mBC) prior to commercial availability in the United States.

Conditions

ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer

Interventions

Giredestrant DRUG

Giredestrant 30 milligrams (mg) will be self-administered orally once a day (QD) on Days 1-28 of each 28-day cycle.

Also known as: GDC-9545, RO7197597, RG6171

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented ER-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Allison et al 2020), defined as ≥1% of tumor cells stained positive, as documented through local laboratory testing of a primary disease specimen
• Documented HER2-negative tumor according to ASCO/CAP guidelines (Wolff et al. 2023), as documented through local laboratory testing of a primary disease specimen
• Adequate hematologic and organ function at screening
• Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to CTCAE v6.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, or other toxicities not considered a safety risk for the participant per treating physician's judgment)
• Agreement to adhere to the contraception requirements
• For women: postmenopausal, premenopausal, or perimenopausal status, defined as follows:
• Postmenopausal status, as defined by at least one of the following criteria: Amenorrhea for ≥12 continuous months with no identified cause other than menopause. If clinically justified or if there is any doubt of postmenopausal state, a high blood follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in participants who are not using hormonal contraception or hormonal replacement therapy. Further guidance for these exceptional circumstances is provided in "Recommendations related to contraception and pregnancy testing in clinical trials" (CTFG 2020). Documented bilateral oophorectomy (≥14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline), hysterectomy, or bilateral salpingectomy.
• Premenopausal or perimenopausal status, as defined by not meeting the above criteria for postmenopausal status.
• Ability to swallow capsules or tablets intact, without chewing or crushing
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Definitive surgery of primary breast tumor(s) and axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB)
• For individuals who have received neoadjuvant chemotherapy and/or had definitive breast cancer surgery and no prior endocrine therapy: surgery must have been performed within 12 months prior to enrollment
• For individuals who have received adjuvant chemotherapy: adjuvant chemotherapy must have been completed prior to enrollment. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and enrollment in EAP.
• Stage I, II, or III breast cancer, with medium or high risk of recurrence
• Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent

You may not qualify if:

• Previous enrollment in Roche- or Genentech-sponsored study of giredestrant
• Current participation in any ongoing Roche- or Genentech-sponsored clinical study of giredestrant
• Eligible for participation in any ongoing Roche- or Genentech-sponsored clinical study of giredestrant
• Inability to comply with EAP and follow-up procedures
• Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of EAP treatment
• Treatment with any investigational therapy within 28 days prior to initiation of EAP treatment
• Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 21 days prior to initiation of EAP treatment
• History of any other malignancy other than breast cancer within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer, or other non-breast cancers at very low risk of recurrence per treating physician's judgment
• Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if have been definitively treated with local therapy (e.g., radiotherapy, surgery), are clinically stable, and have not been treated with anticonvulsants or corticosteroids within 2 weeks prior to initiation of EAP treatment
• Active cardiac disease or history of cardiac dysfunction
• Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (ex: hepatitis B \[HBV\] or hepatitis C \[HCV\]) virus, current alcohol abuse or cirrhosis
• Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
• Serious infection requiring oral or IV antibiotics, or other clinically significant infection, within 14 days prior to initiation of EAP treatment
• Any serious medical condition or abnormality in clinical laboratory tests that, in the treating physician's judgment, precludes the participant's safe participation in and completion of the EAP
• Known allergy or hypersensitivity to any of the EAP drugs or any of their excipients

Sponsors & Collaborators

• Genentech, Inc.: 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

Central Study Contacts

Reference Study ID Number: AL46901 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: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06