Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study

NCT ID: NCT03919253

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2022-04-30

Brief Summary

This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced breast cancer.

Conditions

HER2-positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pyrotinib maleate tablets+nab-paclitaxel

pyrotinib maleate tablets: 400mg orally once daily continunously; nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.

Group Type: EXPERIMENTAL

pyrotinib maleate tablets+nab-paclitaxel

Intervention Type: COMBINATION_PRODUCT

pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.

Interventions

pyrotinib maleate tablets+nab-paclitaxel

pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 1. Age: 18-70 years old，female; 2. Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization) 3. Imaging examination confirmed recurrent/metastatic breast cancer； 4. Patients must have previous treatment with trastuzumab more than 9 weeks; 5. Untreated for metastatic/metastatic disease (except for endocrinotherapy); 6. Patients with at least one measurable lesions by RECIST version 1.1； 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2； 8. Life expectancy greater than or equal to 3 months; 9. Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2*ULN, but ≤5*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50% 10. Doctors believe that treatment can bring benefits to patients； 11. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria

• 1. A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction); 2. Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ); 3. History of psychiatric drugs abuse or patients with mental disorders; 4. Pregnant or lactating women; 5. Less than 4 weeks from the last clinical trial 6. The researchers think inappropriate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HBBL-01

Identifier Type: -

Identifier Source: org_study_id