Preoperative treatment for HR+/HER2+ breast cancer using a combination of medications
Preoperative Treatment of HR+/HER2+Breast Cancer With Pyrrolitinib Combined With Trastuzumab and AI Efficacy and Safety of: a Single Arm Multicenter Phase II Exploratory Study
This study is testing a combination of medications before surgery to see if it can help people with HR+/HER2+ breast cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab, pyrrolitinib |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05885776 on ClinicalTrials.gov |
What this trial studies
This phase II exploratory study investigates the preoperative efficacy and safety of a combination therapy involving pyrrolitinib, trastuzumab, and aromatase inhibitors for patients with HR+/HER2+ breast cancer at stages II to IIIA. The study aims to evaluate the pathological complete response rate and other secondary endpoints such as overall response rate and disease-free survival. Participants will receive a specific regimen of medications, and the study will also explore the feasibility of neoadjuvant therapy and changes in circulating tumor DNA. The research is conducted at multiple centers to gather comprehensive data on the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 75 with stage II to IIIA invasive HR+/HER2+ breast cancer.
Not a fit: Patients with non-invasive breast cancer or those who do not meet the specific hormonal receptor and HER2 status criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the preoperative management and outcomes for patients with HR+/HER2+ breast cancer.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating HR+/HER2+ breast cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female initial treatment patients aged ≥ 18 years and ≤ 75 years old * ECOG score 0-1 * Stage II-IIIA invasive breast cancer, diameter ≥ 20mm * HER2 positive (IHC score of 3+, or 2+and ISH test positive) * ER\>10% * Doctors choose to use letrozole/anastrozole for endocrine therapy * The definition of menopause includes any of the following: (Previous bilateral oophorectomy; Age)≥ 60 years old; Age\<60 years old and without chemotherapy, tamoxifen, toremifen, or ovarian suppressionUnder normal conditions, menopause lasts for ≥ 12 months, and follicle stimulating hormone (FSH) and estradiol are within the postmenopausal range;If receiving tamoxifen or toremifen and age\<60 years, FSH and plasma estradiolWithin the postmenopausal range) * Left ventricular ejection fraction (LVEF) ≥ 50% * 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for females\<470ms； * The functional level of the main organs must meet the following requirements: blood routine: ANC ≥ 1.5 × 109/L； PLT≥90 × 109/L； Hb≥90 g/L；Blood biochemistry: TBIL ≤ 2.5 × ULN； ALT and AST ≤ 2.5 × ULN； BUN and Cr ≤ 1.5 × ULN； * For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment * Agree to abstain or use effective contraceptive methods for at least 2 months after the next administration; .Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up. Exclusion Criteria: * Stage IIIB-IV or inflammatory breast cancer * Metastatic tumor * Previous or concurrent malignant tumors, whose natural history or treatment may interfere with the safety of the research protocol Patients evaluated for sex or efficacy are not eligible to participate in this trial, but basal or squamous cell skin Except for cancer, cervical cancer in situ or bladder cancer, or the subject has no disease (other cancer) to survive At least 5 years. * Active infections that require systemic treatment * Has used any medication in this study within 14 days prior to enrollment * Major surgery (excluding biopsy) performed within 14 days before enrollment * Gastrointestinal dysfunction or diseases may seriously affect the absorption of drugs in this study (such as ulcerative Disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) or Severe damage to the ability to swallow capsules/tablets * Known history of myelodysplastic syndrome or acute myeloid leukemia * Have a history of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days * Have any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months * Within 6 years, there is a history of acute coronary syndrome (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stent implantation) or symptomatic pericarditis
Where this trial is running
Tianjin, Tianjin
- Tianjin Cancer Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: JIE GE, doctor — Tianjin Cancer Hospital
- Study coordinator: xuejing liu, postgraduate
- Email: lxj8109@126.com
- Phone: 18722010265
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.