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

Phase 2

• Conditions: Recurrent Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: docetaxel/ oxaliplatin

• Registration Number: NCT01351597
• Lead Sponsor: Korean Breast Cancer Study Group

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.

Study Timeline

• Study Start: 2011-04
• Status Verified: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Last Update Submitted: 2011-05-10
• Study First Posted: 2011-05-11
• Last Update Posted: 2011-05-11
• Primary Completion: 2013-04
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel/ oxaliplatin	docetaxel/ oxaliplatin	All the patients are recurrent or metastatic breast cancer. Patients with a measurable lesion.

Primary Outcome Measures

Name	Time	Method
overall response rate	2 years

Secondary Outcome Measures

Name	Time	Method
progression free survival	2 years
toxicity	2 years
quality of life	2 years

Trial Locations

Locations (1)

Department of Surgery, Breast Cancer Center, Inje University Paik Hospital; 🇰🇷 Seoul, Korea, Republic of