Clinical trial NCT03939871: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hormone Receptor Positive Advanced Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-05-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: approximately 1.5 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: approximately 6 months
measure: Incidence and Severity of adverse events
timeFrame: approximately 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cacner Center/ Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peng Yuan
role: PRINCIPAL_INVESTIGATOR
References: