A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
Overview
- Phase
- N/A
- Intervention
- pyrotinib combined with Capecitabine
- Conditions
- HER2-positive Breast Cancer
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 3-year IDFS
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.
Investigators
Qiang SUN
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •Female patients ≥ 18 years and ≤ 75 years old;
- •Primary invasive breast cancer confirmed by histology;
- •HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive); lymph node positive, except for T0; lymph node negative and tumor \>1cm, or tumor \> 0.5 cm and ≤ 1cm, and accompanied by any of the following high-risk factors: pathological grade 3, ER/PR negative, or \< 35 years old;
- •Having received mastectomy or breast conserving surgery, and received sentinel lymph node biopsy or axillary lymph node dissection, and within 90 days from the breast surgery;
- •With known ER/PR status of breast cancer;
- •ECOG score 0-1;
- •The patient's major organ functions meet all of the following requirements for blood tests:
- •Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
- •Platelet count (PLT) ≥ 75,000/mm3 (75×109/L);
- •Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
Exclusion Criteria
- Not provided
Arms & Interventions
cohort A
Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w
Intervention: pyrotinib combined with Capecitabine
cohort B
treatment of physician's choice
Intervention: treatment of physician's choice
Outcomes
Primary Outcomes
3-year IDFS
Time Frame: 3 Year
The 3-year IDFS (invasive disease-free survival) is defined as the time from the date of enrollment to the first occurrence of recurrent diseases. Recurrent diseases include ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, remote recurrence and death caused by any reason. The observation period is from enrollment to 3 years after enrollment.
Secondary Outcomes
- AEs and SAEs(3 Year)
- QoL(3 Year)