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出境医 / 临床实验 / A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

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

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 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.
Study Design
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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
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
Other Name: there is no other intervention name
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
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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
Criteria

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

Contacts
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Contact: Peng Yuan, M.D. 13501270834 yuanpeng01@hotmail.com
Contact: Xue Wang, M.D. 13811967690 wxyxyuki@163.com

Locations
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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    yuanpeng01@hotmail.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Peng Yuan Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tracking Information
First Submitted Date  ICMJE May 4, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE December 12, 2017
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2020)
  • 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)
  • Incidence and Severity of adverse events [ Time Frame: approximately 1.5 years ]
    hematologic toxicity，hepatotoxicity and so on
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
  • 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)
  • Incidence and Severity of adverse events [ Time Frame: approximately 1.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer
Official Title  ICMJE Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hormone Receptor Positive Advanced Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: fluvestrant + oral vinorelbine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 12, 2020
Estimated Primary Completion Date December 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peng Yuan, M.D. 13501270834 yuanpeng01@hotmail.com
Contact: Xue Wang, M.D. 13811967690 wxyxyuki@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939871
Other Study ID Numbers  ICMJE NCC1564
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peng Yuan, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peng Yuan Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Chinese Academy of Medical Sciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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