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

Primary Purpose

Hormone Receptor Positive Advanced Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fluvestrant + oral vinorelbine
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Receptor Positive Advanced Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
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

Objective response rate (ORR)
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
hematologic toxicity，hepatotoxicity and so on

Full Information

First Posted
May 4, 2019
Last Updated
June 21, 2020
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03939871
Brief Title
A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer
Official Title
Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
December 12, 2020 (Anticipated)
Study Completion Date
December 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Receptor Positive Advanced Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
fluvestrant + oral vinorelbine
Other Intervention Name(s)
there is no other intervention name
Intervention Description
Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Time Frame
approximately 1.5 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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)
Time Frame
approximately 6 months
Title
Incidence and Severity of adverse events
Description
hematologic toxicity，hepatotoxicity and so on
Time Frame
approximately 1.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Yuan, M.D.
Phone
13501270834
Email
yuanpeng01@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xue Wang, M.D.
Phone
13811967690
Email
wxyxyuki@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Yuan
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yuan
Phone
010-87787240
Email
yuanpeng01@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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