We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351597
First Posted: May 11, 2011
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korean Breast Cancer Study Group
  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: Intervention Model: Single Group Assignment
Masking: None (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 9, 2011
First Posted: May 11, 2011
Last Update Posted: May 11, 2011
Last Verified: May 2011

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
Docetaxel
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action