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

study description
Brief 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

Condition or Disease: Hormone Receptor Positive Advanced Breast Cancer
Intervention/treatment: Drug: fluvestrant + oral vinorelbine
Phase: Phase 2
Detailed Description

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.

study design
Study Type: Interventional
Estimated Enrollment : 30 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer
Actual Study Start Date: December 2017
Estimated Primary Completion Date: December 2020
Estimated Study Completion Date: December 2020

Arms and interventions
Arm Intervention/treatment
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
outcome measures
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

Eligibility Criteria
Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contact: Peng Yuan, M.D. 13501270834 yuanpeng01@hotmail.com

Contact: Xue Wang, M.D. 13811967690 wxyxyuki@163.com

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
More Information
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 :
Breast Neoplasms