A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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);

⁃ Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min;

⁃ Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);

⁃ Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN.

∙ 9\. The participant voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-ups.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Xuefei Wang
1210548954@qq.com
861069158720
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 300
Treatments
cohort A
Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w
cohort B
treatment of physician's choice
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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