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

NCT03939871 | Unknown Phase 2

• 1 other identifier: NCC1564
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hormone Receptor Positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  approximately 1.5 years

Secondary Outcomes (2)

• Objective response rate (ORR)

  approximately 6 months

• Incidence and Severity of adverse events

  approximately 1.5 years

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

fluvestrant + oral vinorelbine DRUG

Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity

Also known as: there is no other intervention name

Single arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Peng Yuan

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

13501270834; yuanpeng01@hotmail.com

Xue Wang, M.D.

CONTACT

13811967690; wxyxyuki@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: December 12, 2017
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

CN (1)