New drug cocktail aims to outsmart resistant breast cancer

NCT ID NCT07708194

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This clinical trial is testing a combination of three drugs—entinostat, pyrotinib, and endocrine therapy—in people with advanced triple-positive breast cancer (cancer that is both hormone receptor-positive and HER2-positive) whose disease has worsened after prior treatment with trastuzumab. The study has two parts: first, to find the safest dose of entinostat when given with the other drugs, and second, to see how well the combination works at controlling the cancer. The goal is to offer a new treatment option for this hard-to-treat form of breast cancer.

What this could mean

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

Active substance
a combination of entinostat (an HDAC inhibitor), pyrotinib (a tyrosine kinase inhibitor), and endocrine therapy
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced triple-positive breast cancer who have stopped responding to standard therapy.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits and risks are not yet fully known. The combination may cause significant side effects or may not improve outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 94 people

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

Started

Jun 2025

Expected to finish

Feb 2027

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. Age ≥ 18 and ≤ 75 years, female, premenopausal or postmenopausal. 2. Histologically confirmed HR+/HER2+ breast cancer (HER2 positive defined as IHC 3+ or FISH confirmed by the pathology department of the study center). 3. Histologically confirmed locally advanced breast cancer (not amenable to curative local therapy) or recurrent/metastatic breast cancer. 4. Prior treatment with trastuzumab and taxane-based anticancer therapy. 5. Received 1-2 prior lines of systemic anticancer therapy in the advanced setting. 6. Life expectancy ≥ 3 months. 7. At least one measurable lesion per RECIST v1.1. 8. ECOG performance status 0-2. 9. All acute toxicities from prior anticancer therapy resolved to Grade 0-1 (per NCI CTCAE v5.0), except alopecia and toxicities deemed by the investigator to pose no safety risk. 10. Adequate bone marrow function: ANC ≥ 1.5×10\^9/L, platelet ≥ 100×10\^9/L, hemoglobin ≥ 90 g/L. 11. Adequate hepatic and renal function: TBIL ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN (or ≤ 5×ULN in the presence of liver metastases); BUN and Cr ≤ 1.5×ULN with creatinine clearance ≥ 50 mL/min. 12. Voluntarily participate and sign written informed consent. - Exclusion Criteria: 1. Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction. 2. Prior treatment with any HDAC inhibitor for antitumor therapy. 3. Prior or current use of any HER2-targeted tyrosine kinase inhibitor (including lapatinib, neratinib, pyrotinib, etc.). 4. Known allergy to any component of the study drugs. 5. Other malignancy within 5 years prior to enrollment, except cured papillary thyroid carcinoma, cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin. 6. Participation in another drug clinical trial within 4 weeks prior to enrollment. 7. History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 8. Uncontrolled significant cardiovascular disease: clinically significant QTc interval prolongation or QTc \> 450 ms at screening; severe cardiac impairment (NYHA \> Class II); unstable angina or myocardial infarction within 6 months; or severe arrhythmia. 9. Pregnant or lactating women, or positive pregnancy test at baseline; or women of childbearing potential who are unwilling to use effective contraception during the study and for at least 8 weeks after the last dose. 10. Concomitant diseases that, in the investigator's judgment, could seriously endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disease, active infection). 11. Known history of neurological or psychiatric disorders, including epilepsy or dementia. 12. Active hepatitis (HBV: HBsAg positive with HBV DNA ≥ 500 IU/mL; HCV: HCV antibody positive with HCV RNA \> ULN). 13. Any condition that, in the investigator's judgment, makes the patient unsuitable for study participation. \-

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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.

  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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