- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341911
Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast Cancer (TNBC) (TNBC)
April 19, 2022 updated by: Xichun Hu, Fudan University
A Phase II, Single-center, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Carboplatin (GC) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer
Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast Cancer (TNBC)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A Phase II, Single-center, Open-Label, Randomized Study of Gemcitabine Plus Cisplatin (GP) Versus Gemcitabine Plus Carboplatin (GC) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xichun Hu, MD, PhD
- Phone Number: 5006 64175590
- Email: huxicun@gmail.com
Study Contact Backup
- Name: Biyun Wang, MD
- Phone Number: 5000 64175590
- Email: pro_wangbiyun@163.com
Study Locations
-
-
-
Shanghai, China, 200032
- Recruiting
- Fudan University Cancer Hospital
-
Contact:
- Biyun Wang, MD
- Phone Number: 5000 64175590
- Email: pro_wangbiyun@163.com
-
Contact:
- Xichun Hu, MD,PhD
- Phone Number: 5006 64175590
- Email: huxicun@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histological proven unresectable recurrent or advanced breast cancer, including de novo stage IV disease.
- 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+). For those with Her2 (1+), FISH test might be considered by the investigator.
- No prior chemotherapy for metastatic breast cancer is permitted. Prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
- At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
- Performance status no more than 1
- All patients enrolled are required to have adequate hematologic, hepatic, and renal function
- Life expectancy longer than 12 weeks
- No serious medical history of heart, lung, liver and kidney
- Be able to understand the study procedures and sign informed consent.
- Patients with good compliance
Exclusion Criteria:
- Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
- Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
- Treatment with an investigational product within 4 weeks before the first treatment
- 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
- Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
- Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
- Uncontrolled serious infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine,cisplatin
GP (gemcitabine and cisplatin combination)
|
Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
Other Names:
|
Active Comparator: Gemcitabine,carboplatin
GC (gemcitabine and carboplatin combination)
|
Gemcitabine 1000 mg/m2, IV drip 30 minutes, D1, D8 Carboplatin AUC 2, IV drip 120 minutes, D1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS (Progression Free Survival)
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate (ORR)
Time Frame: 6 weeks
|
6 weeks
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 weeks
|
6 weeks
|
Overall Survival (OS)
Time Frame: 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
January 13, 2015
First Submitted That Met QC Criteria
January 14, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
April 20, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Carboplatin
- Cisplatin
Other Study ID Numbers
- Fudan BR2015-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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