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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03939871
Recruitment Status : Unknown
Verified June 2020 by Peng Yuan, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 7, 2019
Last Update Posted : June 23, 2020
Information provided by (Responsible Party):
Peng Yuan, Chinese Academy of Medical Sciences

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 Intervention/treatment Phase
Hormone Receptor Positive Advanced Breast Cancer Drug: fluvestrant + oral vinorelbine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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 12, 2017
Estimated Primary Completion Date : December 12, 2020
Estimated Study Completion Date : December 12, 2020

Resource links provided by the National Library of Medicine

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
Other Name: there is no other intervention name

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03939871

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Contact: Peng Yuan, M.D. 13501270834
Contact: Xue Wang, M.D. 13811967690

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China, Beijing
National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100021
Contact: Peng Yuan    010-87787240   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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Principal Investigator: Peng Yuan Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Peng Yuan, Principal Investigator, Chinese Academy of Medical Sciences Identifier: NCT03939871    
Other Study ID Numbers: NCC1564
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action