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

This study is currently recruiting participants.
Verified May 2011 by Korean Breast Cancer Study Group
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
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351597

Contacts
Contact: Ku Sang Kim, M.D. 82-31-219-5200 ideakims@gmail.com

Locations
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     hanse@paik.ac.kr    
Sponsors and Collaborators
Korean Breast Cancer Study Group
Investigators
Principal Investigator: Sehwan Han, MD.PhD. Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
  More Information

No publications provided

Responsible Party: Sehwan Han, Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
ClinicalTrials.gov Identifier: NCT01351597     History of Changes
Other Study ID Numbers: KBCSG008
Study First Received: May 9, 2011
Last Updated: May 10, 2011
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Oxaliplatin
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013