Hormone Receptor Positive Advanced Breast Cancer
Conditions
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.
Interventions
DRUGfluvestrant + oral vinorelbine
Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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) |
| Incidence and Severity of adverse events | approximately 1.5 years | hematologic toxicity，hepatotoxicity and so on |
Countries
China
Contacts
Primary ContactPeng Yuan, M.D.
Backup ContactXue Wang, M.D.
Outcome results
None listed