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Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02607215
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
85
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Platinum Retreated in Patients with Platinum Sensitive mTNBC

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial)
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vinorelbine Plus DDP

Vinorelbine:25 mg/m2, D1, D8 every 21 days DDP:75 mg/m2, D1 every 21 days

Drug: Vinorelbine
25 mg/m2, D1, D8
Other Names:
  • NVB

    • Drug: DDP
    75 mg/m2, D1
    Active Comparator: Vinorelbine

    Vinorelbine:30 mg/m2, D1, D8 every 21 days

    Drug: Vinorelbine
    25 mg/m2, D1, D8
    Other Names:
  • NVB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [6 weeks]

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [6 weeks]

    2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [6 weeks]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Hospital Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Xichun Hu, MD, PhD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xichun Hu, Vice Director of department of medical oncology, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02607215
    Other Study ID Numbers:
    • Fudan BR2015-19
    First Posted:
    Nov 17, 2015
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms
    Vinorelbine

    Study Results

    No Results Posted as of Apr 20, 2022