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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03919253
Other study ID # HBBL-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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