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Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vinorelbine
Gemcitabine
Cisplatin
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed metastatic breast cancer
  • All patients were required to give written informed consent
  • To have received a previous treatment with anthracyclines and taxanes
  • Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
  • At least 4 weeks since the last previous antineoplastic treatment
  • Patients must have recovered from all previous toxicities
  • Karnofsky Performance status >= 70%
  • Adequate hematological, renal, cardiac and hepatic function
  • Life expectancy of at least 12 weeks
  • Patients able to comply and to receive an adequate follow-up

Exclusion Criteria:

  • Only bone metastases
  • Active infection
  • Previous treatment with one of the study drugs
  • Application of other cytotoxic chemotherapy
  • Insufficient renal function (creatinine clearance < 60ml/min)
  • Clinically unstable brain metastasis
  • Pregnancy or lactation
  • Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
  • Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
  • Males
  • Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A

    B

    Arm Description

    Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks

    Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks

    Outcomes

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Overall Survival
    Clinical Benefit Rate
    Duration of response
    Incidence of Treatment-Emergent Adverse Events
    Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS). All patients who received at least one dose of study treatment will be included in the safety analysis.

    Full Information

    First Posted
    August 22, 2015
    Last Updated
    September 5, 2015
    Sponsor
    Shandong Cancer Hospital and Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02544243
    Brief Title
    Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer
    Official Title
    Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong Cancer Hospital and Institute

    4. Oversight

    5. Study Description

    Brief Summary
    Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Vinorelbine
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
    Secondary Outcome Measure Information:
    Title
    Overall Survival
    Time Frame
    Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
    Title
    Clinical Benefit Rate
    Time Frame
    Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
    Title
    Duration of response
    Time Frame
    Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS). All patients who received at least one dose of study treatment will be included in the safety analysis.
    Time Frame
    Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed metastatic breast cancer All patients were required to give written informed consent To have received a previous treatment with anthracyclines and taxanes Previous radiotherapy is allowed, whenever the radiated area is not the only disease location At least 4 weeks since the last previous antineoplastic treatment Patients must have recovered from all previous toxicities Karnofsky Performance status >= 70% Adequate hematological, renal, cardiac and hepatic function Life expectancy of at least 12 weeks Patients able to comply and to receive an adequate follow-up Exclusion Criteria: Only bone metastases Active infection Previous treatment with one of the study drugs Application of other cytotoxic chemotherapy Insufficient renal function (creatinine clearance < 60ml/min) Clinically unstable brain metastasis Pregnancy or lactation Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin) Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted Males Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiyong Yu, PhD
    Phone
    86-13355312277
    Email
    drzhiyongyu@aliyun.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xinzhao Wang, MD
    Phone
    86-15154156639
    Email
    08wangxinzhao@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhiyong Yu, PhD
    Organizational Affiliation
    Shandong Cancer Hospital and Institute
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Xinzhao Wang, MD
    Organizational Affiliation
    Shandong Cancer Hospital and Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

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