|A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer|
|Clinicaltrials.gov identifier||recruitment status||First Posted||Last update posted|
|NCT03939871||Recruiting||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
|Condition or Disease:||Hormone Receptor Positive Advanced Breast Cancer|
|Intervention/treatment:||Drug: fluvestrant + oral vinorelbine|
This is a single-group, single-center phase II trial. Patients with
|Arms and interventions|
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
|Primary Outcome Measures:||
1. Progression-free survival (PFS) [ Time Frame: approximately 1.5 years ]
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
|Secondary Outcome Measures:||
1. Objective response rate (ORR) [ Time Frame: approximately 6 months ]
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)
2. Incidence and Severity of adverse events [ Time Frame: approximately 1.5 years ]
hematologic toxicity，hepatotoxicity and so on
|Ages Eligible for Study:||18 to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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 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.
|Contacts and Locations|
Contact: Peng Yuan, M.D. 13501270834 email@example.com
Contact: Xue Wang, M.D. 13811967690 firstname.lastname@example.org
|China, Beijing||National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College||Beijing|
|Sponsors and Collaborators|
|Chinese Academy of Medical Sciences|
|Principal Investigator :||Peng Yuan||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Responsible Party :||Chinese Academy of Medical Sciences|
|ClinicalTrials.gov Identifier :||NCT03939871|
|Other Study ID Numbers :||NCC1564|
|First Posted :||May 7, 2019|
|Last Update Posted :||June 23, 2020|
|Last Verified :||June 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Additional relevant MeSH terms :||