- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01928680
Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer
February 4, 2015 updated by: Li Qiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase II Study of Capecitabine and Cisplatin in Anthracycline and Taxanes-pretreated Metastatic Triple Negative Breast Cancer Patients
It is a phase II trial to explore the efficacy and safety of cisplatin plus capecitabine in anthracycline and taxane-pretreated metastatic triple negative breast cancer patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Cisplatin contained regimens have been demonstrated to be effective in metastatic triple negative breast cancer patients in some phase II clinical trials.
Meanwhile, Capecitabine is also a highly effective choice for metastatic breast cancer with considerable duration of response.
Combination of cisplatin and capecitabine have been proved effective in metastatic breast cancer in several phase II trials.
This study is aimed to investigate the efficacy and safety of this combination in triple negative breast cancer patients.
Study Type
Interventional
Enrollment (Actual)
33
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 Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Cancer Hospital, ChineseAMS
-
-
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:
- Written and signed informed consent prior to beginning specific protocol procedures.
- Pathologically confirmed Estrogen Receptor(ER), Progesterone Receptor(PR) and Human Epidermal growth factor Receptor HER-2) negative ("triple negative") breast cancer and documented metastatic or locally advanced disease.
Measurable disease - with at least 1 lesion measurable by radiological method
- KPS>=70
- 18 to 70 years old women
- Previously treated with an anthracycline and a taxane
- Hormone therapy for early-stage or metastatic breast cancer was permitted if hormonal receptor positive.
- Treatment with Herceptin for early-stage or metastatic breast cancer is permitted if HER2 positive
Laboratory requirements:
- Hematology Absolute neutrophil count>=1,500 /μl; Platelets>=100,000 /μl; Hemoglobin>=10 g/dl
- Liver function Total bilirubin<=2 times ULN ASAT (SGOT) and ALAT (SGPT)<=2.5 times UNL without liver metastasis or <=5.0 times if liver metastasis Glucose<=200 mg/dL
- Renal function Serum creatinine<=140 mol/l
- Life expectancy of at least 12 weeks
- Patients must be accessible for treatment and follow-up.
- Patients should have recovered from the acute reversible effects of prior treatment. This generally means at least 3 weeks should have elapsed since prior chemotherapy, adjuvant or Neoadjuvant treatment. and at least 4 weeks since prior (radical) radiotherapy or major surgery
Exclusion Criteria:
- Women who are pregnant or breast feeding
- History of brain and/or leptomeningeal metastases
- Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
- Psychiatric disorders or other conditions which would prevent pt. compliance
- Other serious illness or medical condition:
- Congestive heart failure, or unstable angina pectoris, previous history of myocardial infarction within 6 month prior to study entry, uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia of seizures that would prohibit the understanding and giving of informed consent.
- Active uncontrolled infection.
- Unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of Corticosteroids.
- Inability to take and/or absorb oral medicine
- Prior treatment with capecitabine and/or cisplatin
- Concurrent treatment with other experimental drugs, or participation in another clinical trial with any investigational drug within 30 days prior to study entry
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cisplatin/Capecitabine
Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial. |
Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Response Rate
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: 2 years
|
2 years
|
|
Overall Survival
Time Frame: 3 years
|
3 years
|
|
Number and Severity of Adverse Events of Patients Enrolled in This Trial
Time Frame: 1 year
|
Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Binghe Xu, MD, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
November 1, 2012
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
August 26, 2013
First Posted (Estimate)
August 27, 2013
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 4, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LQ0001
- CAMS-LQ0001 (Other Identifier: cams)
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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