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

H

Hebei Medical University

Status and phase

Unknown
Phase 2

Conditions

HER2-positive Breast Cancer

Treatments

Combination Product: pyrotinib maleate tablets+nab-paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT03919253
HBBL-01

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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