Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vinorelbine
Gemcitabine
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring MBC, Vinorelbine, Carboplatin, Gemcitabine, PFS
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vinorelbine/Carboplatin
Gemcitabine/Carboplatin
Arm Description
Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; 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
NCT ID
NCT04143906
First Posted
October 27, 2019
Last Updated
October 27, 2019
Sponsor
Shandong Cancer Hospital and Institute
1. Study Identification
Unique Protocol Identification Number
NCT04143906
Brief Title
Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer
Official Title
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Carboplatin Versus Gemcitabine Plus Carboplatin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 25, 2019 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 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
Keywords
MBC, Vinorelbine, Carboplatin, Gemcitabine, PFS
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
Vinorelbine/Carboplatin
Arm Type
Experimental
Arm Description
Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Arm Title
Gemcitabine/Carboplatin
Arm Type
Experimental
Arm Description
Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
injection
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
Liang Zhang, MD
Phone
86-15165035280
Email
zhang.liang1992@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
Liang Zhang, MD
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer
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