Actively Recruiting
Adjuvant Pyrotinib and Capecitabine for HER2 Positive Microinvasive Breast Cancer
Led by Fudan University · Updated on 2024-03-22
1008
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best adjuvant therapy for women with HER2-positive microinvasive breast cancer, a very early stage of breast cancer where invasive tumors are less than 1 mm in size and lymph nodes are negative. Current guidelines recommend chemotherapy plus targeted therapy for larger or lymph node-positive tumors, but there is limited data for patients with microinvasion. This Phase 2 trial aims to assess the effectiveness and safety of oral capecitabine combined with pyrotinib as an adjuvant treatment for this specific patient group. Participants are randomly assigned to one of two groups. The experimental group receives oral pyrotinib 400 mg once daily and capecitabine 500 mg three times daily for six months. Both groups may also receive endocrine therapy if their tumors are hormone receptor-positive, with medications like tamoxifen or aromatase inhibitors taken for five years. Radiation therapy will be given after chemotherapy if needed. The trial compares this combination therapy to a group receiving no additional chemotherapy or targeted therapy, following surgery. During the study, participants will be monitored for up to five years to assess invasive disease-free survival as the primary outcome. Researchers will also evaluate distant disease-free survival and overall survival. Follow-up includes regular assessments to track treatment adherence, side effects, and long-term outcomes. Participants must be women aged 18 to 70 with specific tumor characteristics and good organ function to take part in this trial.
CONDITIONS
Brief Title
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Early breast cancer after surgery with invasive tumors no larger than 1 mm and no lymph node involvement (T1micN0)
- HER2-positive tumor confirmed by immunohistochemistry (3+) or FISH amplification
- Hormone receptor status defined by ER and PR expression levels
- Both lesions HER2-positive if multiple invasive lesions present
- ECOG performance status of 0 or 1
- No major organ dysfunction
- Blood counts and hemoglobin within specified limits
- Liver function within specified limits
- Renal function with creatinine clearance ≥ 50 mL/min
- Normal cardiac function with ECG and LVEF > 50%
- Effective contraception during treatment for women of childbearing age
- No history of other cancers in past 5 years
- Signed informed consent
- Ability to comply with follow-up and study requirements
You will not qualify if you...
- Invasive tumor larger than 1 mm or positive axillary lymph nodes
- HER2-negative status or no FISH amplification
- Prior neoadjuvant or systemic therapy before enrollment
- History of other malignant tumors except certain cured skin or cervical cancers
- Any metastasis
- Pregnant or lactating women or ineffective contraception in women of childbearing age
- Participation in other clinical trials
- Severe organ dysfunction or uncontrolled cardiovascular, cerebrovascular, or metabolic diseases
- Severe or uncontrolled infections
- History of substance abuse or mental disorders impairing participation
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Half a year
Participants receive Pyrotinib and Capecitabine for half a year. Endocrine drugs are given to hormone receptor-positive patients after chemotherapy. Radiation therapy may start if necessary after chemotherapy.
Regular visits during treatment for medication administration and monitoring
Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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