Using Pyrotinib with Chemotherapy for HR+/HER2- Breast Cancer
Efficacy and Safety of Pyrotinib in Combination with Neoadjuvant Chemotherapy in Stage II-III HR+/HER2-, HER4 High Expression Breast Cancer Patients: a Phase II, Single-center, Randomized, Double-Blinded, Placebo-Controlled Trial
This study is testing if adding a new drug called Pyrotinib to standard chemotherapy can help women with certain types of breast cancer respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | Pyrotinib, chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04872985 on ClinicalTrials.gov |
What this trial studies
This Phase II trial investigates the effectiveness of Pyrotinib, a pan-ErbB receptor tyrosine kinase inhibitor, in combination with standard neoadjuvant chemotherapy for women with hormone receptor positive, HER2-negative stage II to III breast cancer. Participants will be randomly assigned to receive either Pyrotinib or a placebo alongside chemotherapy agents like Doxorubicin and Cyclophosphamide. The primary goal is to assess the rate of pathological complete response (pCR), while secondary outcomes include overall survival and toxicity assessments. The study aims to explore the potential of Pyrotinib in enhancing chemotherapy efficacy, particularly in tumors with high HER4 expression.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with hormone receptor positive, HER2-negative stage II or III breast cancer who have a high expression of HER4.
Not a fit: Patients with HER2-positive breast cancer or those who have previously received treatment for malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with HR+/HER2- breast cancer by increasing the rate of complete tumor response to neoadjuvant therapy.
How similar studies have performed: Previous studies have shown promising results with Pyrotinib in HER2-positive breast cancers, but its efficacy in HR+/HER2- cancers remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presenting with histological(by core needle biopsy or by limited incisional biopsy) proven hormone receptor positive (ER≥10% and/or PR ≥1%), HER2 negative(IHC ≤2+ and/or FISH-) , stage II/ III breast cancer. * Have clinical indication for neoadjuvant therapy. * HER4 IHC score ≥ 4. * Measurable disease (breast and/or lymph nodes). * The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1. * Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l. * Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL. * Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min. * Patients must have the ability to swallow oral medication. * Without history of any kind of treatment to known malignancy (solid tumor or hematologic). * Written informed consent. * Accessible for treatment and follow-up. Exclusion Criteria: * Evidence of stage IV breast cancer. * Contralateral invasive breast cancer or Inflammatory breast cancer. * History of non-breast malignancies (except for in situ cervical cancers, basal cell carcinoma of the skin, squamous cell carcinomas of the skin or thyroid papillary carcinoma that had received curative treatment before enrollment) within 5 years prior to randomization. * Known metastatic disease from any malignancy (solid tumor or hematologic). * Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or QTcF ≥450 msec. * Known hypersensitivity reaction to any of the components of the treatment. * Pregnancy or lactation at the time of randomization. * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Where this trial is running
Guangzhou, Guangdong
- Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Erwei Song, MD.,Phd. — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Kai Chen, MD.,PhD.
- Email: chenkai23@mail.sysu.edu.cn
- Phone: 15920164730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.