New daily pill could help breast cancer patients who Can't tolerate standard hormone drugs
NCT ID NCT07541079
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 9 times
Summary
This phase 3 trial is testing a daily pill called giredestrant in 300 people with ER+/HER2- early breast cancer who had to stop standard aromatase inhibitors due to side effects. The study will track how well patients stick with the treatment, their quality of life, and any side effects over up to 4.5 years. It is an open-label study, meaning everyone knows they are getting the drug, and there is no placebo or comparison group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- giredestrant (a daily oral drug)
- What this could lead to
- If it works, this could offer a well-tolerated daily pill option for people with early breast cancer who cannot take standard hormone therapy.
- What could go wrong
- This is a single-arm, open-label study with no comparison group, so results may be less reliable. Side effects or lack of benefit could still lead to stopping the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jun 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer and Leukemia Center
RECRUITINGSterling Heights, Michigan, 48314, United States
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Orange Coast Medical Center
RECRUITINGFountain Valley, California, 92708-6728, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Older women with Low-Risk breast cancer may avoid unnecessary surgery
- Could a pill replace chemo for some breast cancer patients?