HR+/HER2+(Human epidermal growth factor receptor 2 positive and hormone receptor positive)metastatic breast cancer is a special subtype of HER2+breast cancer. Conventional guidelines recommend chemotherapy combined with trastuzumab targeted therapy for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Pyrotinib is a new class I small molecule Tyrosine kinase inhibitors(TKI) drug with high efficacy and low toxicity after the progress of trastuzumab therapy. Fulvestrant is the most preferred single-drug therapy for HR + metastatic breast cancer recommended unanimously by the guidelines, and fulvestrant and small molecule TKI have synergistic effects. Therefore, we envisage that fulvestrant combined with Pyrotinib in the treatment of HR+/HER2+ metastatic breast cancer in clinical practice has the advantages of improving efficacy and survival. To this end, we intend to conduct a prospective, multi-center, phase II clinical trial to evaluate the efficacy and safety of erlotinib in combination with fulvestrant in patients with human epidermal growth factor receptor 2 (HER2) positive,hormone receptor-positive metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Pyrotinib 400 mg once daily; Fulvestrant 500 mg administered on days 0, 14 (plus or minus 3 days), 28 (plus or minus 3 days), and every 28 (plus or minus 3 days) days
Sun Yat-Sen University Cancer Center
Guangyuan, China
NOT_YET_RECRUITINGSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
RECRUITINGProgression Free Survival (PFS)
From enrollment to progression or death (for any reason)
Time frame: Estimated 12 months
Objective Response Rate (ORR)
Ratio of CR and PR in all subjects
Time frame: Estimated 12 months
Clinical Benefit rate (CBR)
Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects
Time frame: Estimated 12 months
Overall Survival (OS)
From enrollment to death (for any reason)
Time frame: Estimated 24 months
Adverse Events and Serious Adverse Events
Safety
Time frame: From informed consent through 28 days following treatment completion
Efficacy correlation biomarkers
Next Generation Gene Sequencing(NGS) detection of tissue specimens to obtain information on drug sensitivity-related biomarkers , eg, PIK3CA, PTEN, TMB,ESR1,ESR2
Time frame: Estimated 12 months
the quality of life
All patients need to fill in the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer.
Time frame: Estimated 24 months
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