New drug cocktail aims to outsmart resistant breast cancer
NCT ID NCT07708194
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Other studies related to the condition(s) this trial covers.
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- Mind and body: does resilience leave a molecular mark in breast cancer?
- Which pain block works better for breast surgery?
- Can a Triple-Drug combo erase HER2-Positive breast tumors before surgery?
- Bacteria inside tumors may hold the key to breast cancer treatment
- Can a newer drug ease the bone pain of chemotherapy support?