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New cocktail of drugs aims to keep HER2+ breast cancer in check

NCT ID NCT07610720

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial is testing whether adding the drug dalpiciclib to standard anti-HER2 and hormone therapy can help keep advanced breast cancer from growing. It involves 57 women with HR+/HER2+ metastatic breast cancer whose disease has not worsened after initial treatment. The study measures how long participants live without their cancer progressing.

What this could mean

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

Active substance
Dalpiciclib (a CDK4/6 inhibitor) combined with trastuzumab, pertuzumab, pyrotinib, and endocrine therapy (letrozole, anastrozole, exemestane, or fulvestrant)
What this could lead to
If successful, this could offer a new first-line maintenance treatment option to delay cancer progression in people with HR+/HER2+ metastatic breast cancer.
What could go wrong
This is a small Phase 2 trial with only 57 participants, so results may not apply to everyone. Side effects from the drug combination, such as diarrhea, are possible.

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 57 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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 to 75 years

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. Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer. 2. Hormone receptor (HR)-positive and HER2-positive. 3. Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy. 4. ECOG Performance Status: 0-1. Exclusion Criteria: 1. Symptomatic active brain metastases or extensive leptomeningeal metastases. 2. History of Grade 3 or 4 allergic reaction related to the study drugs. 3. Currently receiving other anti-tumor therapies.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma triple-positive breast carcinoma

As listed by the trial registrant

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

Advanced/metastatic breast cancer HER2-positive metastatic 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

  • Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District

    RECRUITING

    Guangdong, GUANGZHOU, 510060, China

More trials for these conditions

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