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Can a drug that blocks HER proteins re-sensitize resistant breast cancer to hormone therapy?

NCT ID NCT07729046

Disease control Sponsor: University of California, San Diego 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial investigates whether adding neratinib, a drug that blocks HER2/3/4 proteins, to standard hormone therapy can improve disease control in people with metastatic ER+/HER2- breast cancer that has stopped responding to first-line endocrine therapy. Participants will receive either standard care alone or standard care plus daily neratinib. The study aims to see if the combination extends the time before the cancer progresses and to assess side effects.

What this could mean

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

Active substance
neratinib plus standard endocrine therapy
What this could lead to
If it works, this could offer a new treatment option for people with metastatic breast cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a mid-stage trial, so the added benefit is uncertain. Neratinib can cause side effects like diarrhea, and the combination may not improve outcomes for all participants.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Expected to start

Jul 2027

An estimate. Start dates often move.

Expected to finish

Jun 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Female participants only

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: 1. Female over the age of 18 at the time of study enrollment 2. Not pregnant, planning to become pregnant or breast feeding 3. Metastatic ER+/HER2- breast cancer that has progressed on 1st line therapy including endocrine therapy +/- CDK4/6 inhibitors 4. At least one metastatic lesion visible on imaging (including FDG-PET) 5. At least one metastatic lesion must be biopsied and confirmed ER+ and HER2- by immunohistochemistry within 6 months of study screening (HER2 equivocal disease will be confirmed HER2- by FISH) 6. Tumors must be MLH1-low defined by \<50% tumor cells positive for nuclear MLH1 expression on immunohistochemistry 7. Standard of care next line endocrine therapy can include any endocrine therapy 8. Performance status ECOG \> 3 9. Life expectancy \> 1 year 10. Ability to get serial imaging studies Exclusion Criteria: 1. History of concurrent use of other HER2-targeted therapy 2. Concurrent use of other targeted systemic therapy 3. History of other cancers other than non-melanoma skin cancer 4. Actionable mutations on tumor genomic sequencing will be ineligible, and those participants encouraged to proceed with the relevant targeted therapy 5. Participants where there is not at least one imaging apparent lesion that has not been treated with prior targeted therapy (for example palliative radiation or cryoablation) 6. Contraindications to Neratinib use including allergy or hypersensitivity 7. Baseline grade 3+ diarrhea

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer hormone receptor-positive breast cancer hormone-resistant breast carcinoma invasive breast carcinoma

As listed by the trial registrant

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

ER+, HER2-, metastatic breast cancer Metastatic invasive breast cancer Resistant breast cancer

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • UC San Diego Health Moores Cancer Center

    La Jolla, California, 92037, United States

More trials for these conditions

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