This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

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

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

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

Locations

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

Investigators

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