Platinum Rechallenge in Patients With Platinum-sensitive mTNBC
NCT ID: NCT02607215
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
84 participants
INTERVENTIONAL
2015-11-30
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vinorelbine Plus DDP
Vinorelbine:25 mg/m2, D1, D8 every 21 days
DDP:75 mg/m2, D1 every 21 days
Vinorelbine
25 mg/m2, D1, D8
DDP
75 mg/m2, D1
Vinorelbine
Vinorelbine:30 mg/m2, D1, D8 every 21 days
Vinorelbine
25 mg/m2, D1, D8
Interventions
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Vinorelbine
25 mg/m2, D1, D8
DDP
75 mg/m2, D1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xichun Hu
Vice Director of department of medical oncology
Principal Investigators
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Xichun Hu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Fudan BR2015-19
Identifier Type: -
Identifier Source: org_study_id
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