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Daily pill giredestrant put to the test for sticking with breast cancer treatment

NCT ID NCT07827573

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are studying giredestrant, an experimental daily pill, in people with estrogen receptor-positive, HER2-negative early breast cancer. The trial enrolls about 1,500 participants, including some who switch to giredestrant after other treatments. It tracks how many people stay on the drug, side effects, and patient-reported outcomes like joint pain. The goal is to see whether giredestrant is tolerable and easy to take over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
giredestrant, an experimental daily pill that blocks estrogen
What this could lead to
If giredestrant proves tolerable and easy to take, it could offer a daily pill option for people with ER-positive early breast cancer, including those switching from other endocrine therapies.
What could go wrong
The study measures adherence and side effects, not whether the drug prevents cancer from returning. People may still stop the pill because of joint pain or other side effects, and the results may not apply to everyone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer * Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy) * Participants must have completed any prior adjuvant chemotherapy before enrollment, if given * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2 * Adequate organ function * Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required * Diagnosis of inoperable locally advanced or Stage IV breast cancer * History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS) * Planned surgery during the study * Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents * Active cardiac disease or history of cardiac dysfunction

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early breast cancer Estrogen-receptor-positive breast cancer HER2-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.