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

• Status: Recruiting
• Trial end date: 2020-12-12
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Hormones; Vinorelbine

Criteria

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.