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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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

Clinicaltrials.gov identifier NCT03939871

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted 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

- 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

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 History of Changes
  • Other Study ID Numbers: NCC1564
  • First Posted: May 7, 2019 Key Record Dates
  • 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