Comparing two treatments for HER2-positive breast cancer before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a combination of albumin paclitaxel, trastuzumab, and pyrrolitinib against a standard treatment of docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer. The study aims to determine which treatment leads to a higher rate of pathologic complete response (pCR) and improved disease-free survival. Participants will be monitored for adverse reactions and overall treatment efficacy. The trial includes patients aged 18-65 with measurable HER2-positive invasive breast cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18-65 years old, ECOG 0-1 point.
2. Clinical T2-T4d, or T1c with axillary LN+.
3. HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \[FISH\] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital).
4. Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.
5. Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy:Absolute value of neutrophil count ≥ 2.0 × 109/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 109/L;Total bilirubin\<1.5 ULN (upper limit of normal value); Creatinine\<1.5 × ULN; AST/ALT \< 1.5 × ULN.
6. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%).
7. Women of childbearing age tested negative for serum pregnancy test 14 days before randomization.
8. Sign an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer.
2. Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
3. The patient has a second primary malignant tumor, except for fully treated skin cancer.
4. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
5. Serious heart disease or discomfort, including but not limited to the following diseases:Confirmed history of heart failure or systolic dysfunction (LVEF\<50%); High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate\>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block; Angina pectoris requiring treatment with anti angina drugs; Clinically significant heart valve disease; ECG shows transmural myocardial infarction; Poor control of hypertension (systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>100 mmHg).
6. Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
7. Individuals with a known history of allergies to the drug components of this protocol; Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

Where it's running

• Henan cancer hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Zhenzhen Liu — Study Principal Investigator
• Study coordinator: Zhenzhen Liu
• Email: liuzhenzhen73@126.com
• Phone: 13603862755

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can we skip radiation after lumpectomy for low-risk HER2-positive breast cancer?

  This study tests whether patients who had breast-conserving surgery and low-risk HER2-positive breast cancer can safely skip radiation therapy while receiving HER2-targeted treatment.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895511

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• ctDNA-guided sequential anti-HER2 therapy with CNS prophylaxis for HER2-positive metastatic breast cancer

  This trial will test whether using regular ctDNA blood tests to guide stepping up or down sequential anti-HER2 treatments, together with local therapies and measures to protect the brain and spinal cord, can produce long-lasting remission for people with HER2-positive stage IV breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07459673

• Neoadjuvant zanidatamab plus chemotherapy for HER2-positive early breast cancer

  This study will test if adding zanidatamab to chemotherapy given before surgery helps people with HER2-positive early-stage breast cancer.

  Recruiting at 53 sites Phase 2 Jazz Pharmaceuticals · Long Beach, California and 52 other locations · NCT07102381

• Radiology-based prediction of HER2 level and T‑DXd benefit in metastatic breast cancer

  This study tests whether patterns in CT or FDG‑PET images can show HER2 level and help predict response to trastuzumab deruxtecan for people with metastatic breast cancer.

  Recruiting Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Milan · NCT07030569

• Vaccine targeting HER2 in locally advanced breast cancer

  This trial will test a vaccine that boosts the immune system to attack HER2-positive breast cancer in adults with locally advanced or high-risk disease.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT06949410

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.