Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Study Overview
=================
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)

Official Title
-----------------
Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial)

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Vinorelbine
* Drug: DDP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females with age between 18 and 70 years old Performance status no more than 2 Life expectancy longer than 3 months Histological proven unresectable recurrent or advanced breast cancer 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+). 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). At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1) Radiation therapy within 4 weeks prior to enrollment All patients enrolled are required to have adequate hematologic, hepatic, and renal function Be able to understand the study procedures and sign informed consent. Exclusion Criteria: Patients had prior treatment with vinorelbine Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 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 Treatment with an investigational product within 4 weeks before the first treatment Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction Uncontrolled serious infection Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vinorelbine Plus DDP<br>Vinorelbine:25 mg/m2, D1, D8 every 21 days DDP:75 mg/m2, D1 every 21 days | Drug: Vinorelbine<br>* 25 mg/m2, D1, D8<br>* Other names: NVB;Drug: DDP<br>* 75 mg/m2, D1<br>|
| Active Comparator: Vinorelbine<br>Vinorelbine:30 mg/m2, D1, D8 every 21 days | Drug: Vinorelbine<br>* 25 mg/m2, D1, D8<br>* Other names: NVB;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | 6 weeks | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 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 |