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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03919253
• Other study ID #: HBBL-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 30, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2019
• Source: Hebei Medical University Fourth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival(PFS)	Baseline to measured date of progress or death from any cause	three years
Secondary	Objective response rate (ORR)	Baseline to measured stable disease	three years
Secondary	Clinical Benefit Rate (CBR)	The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks	three years
Secondary	Disease control rate(DCR)	Rate of the patients with disease control	three years
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	up to death
Secondary	Safety (number of Participants with adverse events)	Adverse events Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The number of Participants with adverse events will be recorded at each treatment visit.	three years