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Can a drug combo replace chemo before breast cancer surgery?

NCT ID NCT07795424

Disease control Sponsor: Shengjing Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase II trial tests whether a combination of culmerciclib, letrozole, trastuzumab, and pertuzumab can shrink tumors before surgery in people with HR-positive, HER2-positive early or locally advanced breast cancer. About 33 participants who have not had prior treatment will receive the drugs for five cycles, then undergo surgery. The main goal is to see how many achieve a pathological complete response, meaning no cancer remains in the breast or lymph nodes at the time of surgery.

What this could mean

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

Active substance
culmerciclib (a CDK4/6 inhibitor) combined with letrozole, trastuzumab, and pertuzumab
What this could lead to
If it works, this could offer a chemotherapy-free option to shrink tumors before surgery, potentially reducing the need for chemo and its side effects.
What could go wrong
This is a small, early-phase study with only 33 participants, so results may not apply broadly. The combination may not be effective enough or could cause unexpected side effects.

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 33 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 70 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: * Histologically confirmed HR-positive (ER \>=50%, PR \>=10%) and HER2-positive (IHC 3+ or ISH+) breast cancer; * Clinical stage II-III (AJCC 8th edition); * Treatment-naive: no prior systemic anti-tumor therapy for breast cancer; * ECOG performance status 0-1; * Adequate organ function; * Signed informed consent. Exclusion Criteria: * Distant metastasis (stage IV disease); * Prior chemotherapy, endocrine therapy, or anti-HER2 therapy for the current breast cancer; * Severe cardiac dysfunction or left ventricular ejection fraction (LVEF) below the institutional lower limit of normal; * Pregnancy or lactation; * Any other condition that, in the investigator's opinion, makes the patient unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-positive breast carcinoma

As listed by the trial registrant

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

Breast cancer HR positive, HER2 positive 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

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042, China

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