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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 because the information has not been verified recently.
Verified May 2011 by Korean Breast Cancer Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01351597
First received: May 9, 2011
Last updated: May 10, 2011
Last verified: May 2011

May 9, 2011
May 10, 2011
April 2011
April 2013   (final data collection date for primary outcome measure)
overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01351597 on ClinicalTrials.gov Archive Site
  • progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Breast Cancer
  • Metastatic Breast Cancer
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®
Experimental: docetaxel/ oxaliplatin
All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
Intervention: Drug: docetaxel/ oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
September 2013
April 2013   (final data collection date for primary outcome measure)

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.
Female
20 Years to 70 Years
No
Contact: Ku Sang Kim, M.D. 82-31-219-5200 ideakims@gmail.com
Korea, Republic of
 
NCT01351597
KBCSG008
Yes
Sehwan Han, Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Korean Breast Cancer Study Group
Not Provided
Principal Investigator: Sehwan Han, MD.PhD. Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
Korean Breast Cancer Study Group
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP