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A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer (STORM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Korean Breast Cancer Study Group.
Recruitment status was:  Recruiting
Information provided by:
Korean Breast Cancer Study Group Identifier:
First received: May 9, 2011
Last updated: May 10, 2011
Last verified: May 2011
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.

Condition Intervention Phase
Recurrent Breast Cancer
Metastatic Breast Cancer
Drug: docetaxel/ oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • overall response rate [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 2 years ]
  • toxicity [ Time Frame: 2 years ]
  • quality of life [ Time Frame: 2 years ]

Estimated Enrollment: 51
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: docetaxel/ oxaliplatin
All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
Drug: docetaxel/ oxaliplatin
  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
Other Names:
  • Detaxel®
  • oxalitin®

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.

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women aged : 20~70 years
  2. WHO (ECOG) performance status 0-2
  3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
  4. patients had previously not received chemotherapy of recurrent or metastatic lesion.
  5. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

  1. Patients with previous chemotherapy for recurrent breast cancer
  2. Breast cancer recurrence within 12 months after taxane treatment
  3. Her-2/neu expression breast cancer
  4. 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.
  5. Brain metastasis
  6. uncontrolled infection, medically uncontrollable heart disease
  7. other serious medical illness or prior malignancies
  8. Pregnant or lactating women were excluded.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01351597

Contact: Ku Sang Kim, M.D. 82-31-219-5200

Korea, Republic of
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Sehwan Han, MD. PhD.    82-2-950-1018   
Sponsors and Collaborators
Korean Breast Cancer Study Group
Principal Investigator: Sehwan Han, MD.PhD. Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
  More Information

Responsible Party: Sehwan Han, Department of Surgery, Breast Cancer Center, Inje University Paik Hospital Identifier: NCT01351597     History of Changes
Other Study ID Numbers: KBCSG008
Study First Received: May 9, 2011
Last Updated: May 10, 2011

Keywords provided by Korean Breast Cancer Study Group:
recurrent breast cancer
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017