A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
STORM
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
1 other identifier
interventional
51
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 11, 2011
May 1, 2011
2 years
May 9, 2011
May 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
2 years
Secondary Outcomes (3)
progression free survival
2 years
toxicity
2 years
quality of life
2 years
Study Arms (1)
docetaxel/ oxaliplatin
EXPERIMENTALAll the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
Interventions
1. docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks 2. oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Seoul, 139-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sehwan Han, MD.PhD.
Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 11, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2013
Study Completion
September 1, 2013
Last Updated
May 11, 2011
Record last verified: 2011-05