- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351597
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer (STORM)
May 10, 2011 updated by: Korean Breast Cancer Study Group
An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer
The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome.
This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.
Study Type
Interventional
Enrollment (Anticipated)
51
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: Ku Sang Kim, M.D.
- Phone Number: 82-31-219-5200
- Email: ideakims@gmail.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 139-707
- Recruiting
- Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
-
Contact:
- Sehwan Han, MD. PhD.
- Phone Number: 82-2-950-1018
- Email: hanse@paik.ac.kr
-
-
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
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged : 20~70 years
- WHO (ECOG) performance status 0-2
- Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- patients had previously not received chemotherapy of recurrent or metastatic lesion.
- Have given written informed consent and are available for prolonged follow-up
Exclusion Criteria:
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression breast cancer
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
- uncontrolled infection, medically uncontrollable heart disease
- other serious medical illness or prior malignancies
- Pregnant or lactating women were excluded.
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: docetaxel/ oxaliplatin
All the patients are recurrent or metastatic breast cancer.
Patients with a measurable lesion.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall response rate
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: 2 years
|
2 years
|
progression free survival
Time Frame: 2 years
|
2 years
|
toxicity
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sehwan Han, MD.PhD., Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
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
April 1, 2011
Primary Completion (Anticipated)
April 1, 2013
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
May 9, 2011
First Submitted That Met QC Criteria
May 10, 2011
First Posted (Estimate)
May 11, 2011
Study Record Updates
Last Update Posted (Estimate)
May 11, 2011
Last Update Submitted That Met QC Criteria
May 10, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBCSG008
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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