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

Primary Purpose

Recurrent Breast Cancer, Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
docetaxel/ oxaliplatin
Sponsored by
Korean Breast Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Breast Cancer focused on measuring recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery, Breast Cancer Center, Inje University Paik HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

docetaxel/ oxaliplatin

Arm Description

All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

progression free survival
toxicity
quality of life

Full Information

First Posted
May 9, 2011
Last Updated
May 10, 2011
Sponsor
Korean Breast Cancer Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01351597
Brief Title
A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
Acronym
STORM
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Korean Breast Cancer Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Breast Cancer, Metastatic Breast Cancer
Keywords
recurrent breast cancer, metastatic breast cancer, docetaxel, oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
docetaxel/ oxaliplatin
Arm Type
Experimental
Arm Description
All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.
Intervention Type
Drug
Intervention Name(s)
docetaxel/ oxaliplatin
Other Intervention Name(s)
Detaxel®, oxalitin®
Intervention Description
docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
2 years
Title
toxicity
Time Frame
2 years
Title
quality of life
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ku Sang Kim, M.D.
Phone
82-31-219-5200
Email
ideakims@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sehwan Han, MD.PhD.
Organizational Affiliation
Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sehwan Han, MD. PhD.
Phone
82-2-950-1018
Email
hanse@paik.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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