Can a Triple-Drug combo erase HER2-Positive breast tumors before surgery?
NCT ID NCT05444998
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase II trial tests whether giving a combination of inetetamab, pyrotinib, and nab-paclitaxel before surgery can eliminate cancer in women with HER2-positive early or locally advanced breast cancer. Participants receive four cycles of the drugs, then undergo surgery. The main goal is to see how many women have no invasive cancer remaining 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
- A combination of three drugs given before surgery: inetetamab (an anti-HER2 antibody), pyrotinib (a tyrosine kinase inhibitor), and nab-paclitaxel (a chemotherapy drug).
- What this could lead to
- If this combination works, it could shrink or eliminate HER2-positive breast tumors before surgery, potentially improving long-term outcomes and offering a new neoadjuvant option.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply broadly. The drug combination can cause side effects, and the trial does not yet prove long-term benefit.
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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
-
20 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Dec 2023
- 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
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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. female treatment-naive patients aged ≥ 18 years and ≤ 75 years; 2. ECOG score 0 \~ 1; 3. HER2-positive breast cancer confirmed by pathological examination, defined as an immunohistochemical (IHC) score of 3 + in \> 10% of immunoreactive cells or HER2 gene amplification by in situ hybridization (ISH) results (HER2 gene signal to centromere 17 signal ratio ≥ 2.0 or HER2 gene copy number ≥ 6). 4. known hormone receptor status (ER and PgR); 5. The functional level of major organs must meet the following requirements (no blood transfusion, no leukocyte-elevating and platelet-elevating drugs are used 2 before screening): 1\) Blood routine neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L; 2) Blood biochemical total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) echocardiography score (LVEF) ≥ 55%; 4) 12 ECG Fridericia-corrected QT interval (QTcF) \< 470 msec; 6. For premenopausal or non-surgically sterile female patients: agree to abstain from sexual intercourse or use effective contraceptive methods during treatment and for at least 7 months after the last dose of the study treatment. 7\. Voluntarily join this study, sign the informed consent form, have good compliance and are willing to cooperate with the follow-up. Exclusion Criteria: 1. stage IV (metastatic) breast cancer; 2. inflammatory breast cancer; 3. Previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors; 4. concurrent anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 5. Patients who have undergone major surgical procedures unrelated to breast cancer before enrollment, or have not fully recovered from such surgical procedures; 6. severe heart disease or discomfort 7. inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption; 8. known to have a history of allergy to the drug components of this protocol: a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 7 months after the study; 10\. suffering from serious concomitant diseases or other diseases that will interfere with the planned treatment of concomitant diseases, or any other conditions that the investigator believes that the patient is not suitable for this study
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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.
Contacts and locations
Locations
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First Affiliated Hospital of Fourth military medical universit
Xi'an, Shannxi, 710032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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