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

Korean Breast Cancer Study Group

Status and phase: Unknown; Phase 2

Conditions: Metastatic Breast Cancer; Recurrent Breast Cancer

Treatments: Drug: docetaxel/ oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01351597

KBCSG008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

docetaxel/ oxaliplatin

Experimental group

Description:

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

Treatment:

Drug: docetaxel/ oxaliplatin