ER+/HER2- Early or Locally Advanced/Metastatic Breast CancerNCT07643831
Expanded Access Program to Provide Giredestrant to Participants With ER+, HER2- Early or Locally Advanced/Metastatic Breast Cancer
A study testing Giredestrant in people with ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer, run by Genentech, Inc. at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer
- What is being tested?
- Giredestrant
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
- Inclusion Criteria for Locally Advanced/Metastatic Breast Cancer (LA/mBC) Cohort:
Show all 27Show fewer
- Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Disease progression after ≥6 months on endocrine therapy (ET) plus cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in the LA/mBC setting, or recurrence while taking or within 12 months of taking combination adjuvant ET plus CDK4/6i
- Documentation of the presence of a ESR1 mutation
- General Exclusion Criteria:
- 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
- Pregnant or breastfeeding, or intending to become pregnant during the EAP or within the timeframe in which contraception is required
Who cannot join
- Current treatment or planned treatment with CDK4/6i as neoadjuvant or adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6i therapy prior to enrollment is allowed. A washout period of approximately 7 days is required between the last dose of CDK4/6i therapy and enrollment.
- History of >12 weeks of any endocrine treatment with selective ER modulator (e.g., tamoxifen), degrader, or aromatase inhibitor
- Progression on more than two prior lines of systemic ET in the locally advanced unresectable or metastatic breast cancer setting
- Prior treatment with an oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions [pleural, pericardial, peritoneal] or pulmonary lymphangitis)
- Known positive HIV status and meeting any of the following criteria: CD4+ T-cell count of <350 cells/uL; Detectable HIV viral load; History of an opportunistic infection within the past 12 months; On stable antiretroviral therapy for <4 weeks
- Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection, potentially affecting enteral absorption, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea
Trial locations and contacts
9 sites in 1 country.
Reference Study ID Number: AL46901 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
9 sites in 1 country
United States9 sites
- Available
Alaska Oncology and Hematology
Anchorage, Alaska, 99508-2959
- Available
Lynn Cancer Institute
Boca Raton, Florida, 33486-2305
- Available
San Juan Oncology Associates - Four Corners Cancer Center
Farmington, New Mexico, 87401-8900
- Available
Orange Coast Medical Center
Fountain Valley, California, 92708-6728
- Available
West Virginia University (WVU) - WVU Cancer Institute
Morgantown, West Virginia, 26506-1200
- Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914
- Available
Redlands Oncology Center for Cancer Care
Redlands, California, 92373
- Available
Northwest Medical Specialties (Tacoma)
Tacoma, Washington, 98405-5016
- Available
New England Cancer Specialists - Westbrook
Westbrook, Maine, 04092
About this study
Official title: A Multicenter, Open-Label Expanded Access Program to Provide Giredestrant to Patients With ER+, HER2- Early or Metastatic Breast Cancer
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.
- Being tested
- Giredestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiredestrantDrug
Also called GDC-9545, RO7197597, RG6171
Giredestrant 30 milligrams (mg) will be self-administered orally once a day (QD) on Days 1-28 of each 28-day cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER+/HER2- Early or Locally Advanced/Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643831
- Sponsor's protocol ID
- AL46901
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Expanded Access Program to Provide Giredestrant to Patients With ER+, HER2- Early or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07643831
- Acronym / sponsor ID
- AL46901
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (7 listed)
- Current treatment or planned treatment with CDK4/6i as neoadjuvant or adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6i therapy prior to enrollment is allowed. A washout period of approximately 7 days is required between the last dose of CDK4/6i therapy and enrollment.
- History of >12 weeks of any endocrine treatment with selective ER modulator (e.g., tamoxifen), degrader, or aromatase inhibitor
- Progression on more than two prior lines of systemic ET in the locally advanced unresectable or metastatic breast cancer setting
- Prior treatment with an oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions [pleural, pericardial, peritoneal] or pulmonary lymphangitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GiredestrantAlso: GDC-9545, RO7197597, RG6171Giredestrant 30 milligrams (mg) will be self-administered orally once a day (QD) on Days 1-28 of each 28-day cycle. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- 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.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reference Study ID Number: AL46901 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giredestrant in people with ER+/HER2- Early or Locally Advanced/Metastatic Breast Cancer, run by Genentech, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: AL46901 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.