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

Hormone Receptor Positive Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03939871
• Other study ID #: NCC1564
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2017
• Est. completion date: December 12, 2020

Study information

• Verified date: June 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Peng Yuan, M.D.
• Phone: 13501270834
• Email: yuanpeng01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone Receptor Positive Advanced Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	approximately 6 months
Secondary	Incidence and Severity of adverse events	hematologic toxicity,hepatotoxicity and so on	approximately 1.5 years