Metastatic Breast Cancer
Conditions
Brief summary
Platinum Retreated in Patients with Platinum Sensitive mTNBC
Detailed description
Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)
Interventions
DRUGVinorelbine
25 mg/m2, D1, D8
DRUGDDP
75 mg/m2, D1
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Females with age between 18 and 70 years old 2. Performance status no more than 2 3. Life expectancy longer than 3 months 4. Histological proven unresectable recurrent or advanced breast cancer 5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER \<1%, PR \<1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). 6. Patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. Platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose). 7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1) 8. Radiation therapy within 4 weeks prior to enrollment 9. All patients enrolled are required to have adequate hematologic, hepatic, and renal function 10. Be able to understand the study procedures and sign informed consent.
Exclusion criteria
1. Patients had prior treatment with vinorelbine 2. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 3. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration 4. Treatment with an investigational product within 4 weeks before the first treatment 5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction 6. Uncontrolled serious infection 7. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 6 weeks |
| Objective Response Rate (ORR) | 6 weeks |
| Overall Survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
Countries
China
Contacts
Primary ContactXichun Hu, MD, PhD
Backup ContactZhonghua Wang, MD
Outcome results
None listed