New drug cocktail aims to wipe out Triple-Positive breast tumors before surgery
NCT ID NCT07299890
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a combination of four drugs (trastuzumab, pertuzumab, palbociclib, and exemestane) given before surgery to 90 people with early-stage triple-positive breast cancer. The goal is to see if this treatment can completely eliminate cancer cells in the breast and lymph nodes. Participants will receive the drugs for a set period before surgery, and researchers will monitor how well the tumors respond and any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 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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Anyone
- 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: * The patient must meet all of the following criteria to be included in the study: 1. The tumor stage must be in accordance with the 8th edition of the AJCC standard, being stage II-III for the initial diagnosis; 2. Pre-menopausal or perimenopausal patients (if this is the case, combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or post-menopausal patients; 3. All patients must have been pathologically confirmed as HR+/HER2 receptor positive. The estrogen receptor (ER) is positive (\>10%), the progesterone receptor (PR) is positive (\>1%), and the HER2 receptor is positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guideline standards. The immunohistochemistry (IHC) score is 3+ or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate ≥ 2.0); 4. Age 18-75 years (inclusive of 18 and 75), female; 5. ECOG score 0-1; 6. Expected survival time ≥ 12 weeks; 7. According to the RECIST 1.1 standard, there must be at least one measurable lesion; 8. The functional level of organs must meet the following requirements: (a) Blood routine: ANC ≥ 1.5×109/L; PLT ≥ 90×109/L; Hb ≥ 90g/L; (b) Blood biochemistry: TBIL ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; BUN and Cr ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL/min; (c) Cardiac echocardiography: Left ventricular ejection fraction ≥ 50%: 9. The subject voluntarily joins this study, signs the informed consent, has good compliance and is willing to cooperate with follow-up. Exclusion Criteria: * If the patient meets any of the following conditions, they will not be eligible: 1. Has received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. Is concurrently receiving other anti-tumor drug treatments; 3. Stage IV breast cancer; 4. Breast cancer without pathological tissue diagnosis; 5. Has had other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin; 6. Patients with severe dysfunction of important organs such as heart, liver, and kidney; 7. Unable to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting the administration and absorption of the drugs; 8. Participated in other drug clinical trials within 4 weeks before enrollment; 9. Has a history of immunodeficiency diseases, including positive HIV test, HCV, active viral hepatitis or other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 10. Has a known history of allergic reaction to the components of this drug regimen; 11. Has had any heart diseases, including: requiring drug treatment or clinically significant arrhythmia; myocardial infarction; heart failure; any other heart diseases judged by the researcher as unsuitable for participation in this trial; 12. Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results; 13. According to the investigator's judgment, there are serious accompanying diseases that endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.); 14. Has a clear history of neurological or mental disorders, including epilepsy or dementia; 15. The investigator considers that the patient is not suitable for participating in this study in any other circumstances.
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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 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
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