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

Metastatic Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01351597
• Other study ID #: KBCSG008
• Status: Recruiting
• Phase: Phase 2
• First received: May 9, 2011
• Last updated: May 10, 2011
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2011
• Source: Korean Breast Cancer Study Group
• Contact: Ku Sang Kim, M.D.
• Phone: 82-31-219-5200
• Email: ideakims[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Recurrent Breast Cancer

Intervention

Drug:
• docetaxel/ oxaliplatin
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

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Breast Cancer Center, Inje University Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		2 years	Yes
Secondary	progression free survival		2 years	Yes
Secondary	toxicity		2 years	Yes
Secondary	quality of life		2 years	Yes