May 7, 2019
June 23, 2020
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
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.
|Experimental: Single arm
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
Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity
- 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.
- 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
- 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
- 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
- Other ineligible conditions according to the researcher's judgment.
Contact: Peng Yuan, M.D. 13501270834 email@example.com
Contact: Xue Wang, M.D. 13811967690 firstname.lastname@example.org
National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Chinese Academy of Medical Sciences
Principal Investigator: Peng Yuan Cancer Institute and Hospital, Chinese Academy of Medical Sciences