A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

Study Overview
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Brief Summary
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This is a single-center phase II study designed to evaluated the efficacy and safety of fulvestrant in combination with oral vinorelbine in hormone receptor-positive advanced breast cancer

Detailed Description
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This is a single-group, single-center phase II trial. Patients with hormone-receptor-positive, Her2-negative recurrent or metastatic breast cancer who had not previously received any systemic antitumor therapy for advanced disease were treated with fulvestrant combined with oral vinorelbine as a first-line regimen. Key issues to be addressed in this study: to observe and evaluate the efficacy and safety of fulvestrant combined with oral vinorelbine in the treatment of hormone-receptor-positive and HER2-negative advanced breast cancer. Thirty patients are planned to be enrolled.

Official Title
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Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

Conditions
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Hormone Receptor Positive Advanced Breast Cancer

Intervention / Treatment
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* Drug: fluvestrant + oral vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 year-old women; Pathologically or cytologically confirmed breast cancer; Hormone receptor-positive ECOG score: 0-1, expected survival time ≥ 3months; Recurrence after adjuvant therapy or metastatic breast cancer and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer. Patients must have measurable disease according to RECIST criteria Version 1.1. Bone metastases lesions were excluded. The patients have adequate hematologic and organ function. Exclusion Criteria: Patients with symptomatic brain metastases. Patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug. Received ≥1 standard chemotherapy regimen (excluding endocrine therapy) for advanced breast cancer. Participation in other clinical trials within 4 weeks before enrollment. Severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ECG, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension. Severe or uncontrolled infection. Any factors that affect the oral administration and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); Active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin). Patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation. Need to concurrent other cancer therapy(other than palliative care for non-target lesions). Other ineligible conditions according to the researcher's judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Fluvestrant in combination with oral Vinorelbine Fluvestrant: administered at a dose of 0.5g once im every 28 days. Vinorelbine: administered at a dose of 60mg/kg once a week for 3 weeks p.o. every 28 days. | Drug: fluvestrant + oral vinorelbine<br>* Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity<br>* Other names: there is no other intervention name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause | approximately 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The ORR will be calculated as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR) | approximately 6 months | 
| Incidence and Severity of adverse events | hematologic toxicity，hepatotoxicity and so on | approximately 1.5 years |