Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer (NeoTG)

Korean Breast Cancer Study Group

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer Stage II; Breast Cancer Stage III

Treatments: Drug: gemcitabine; Drug: docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01352494

KBCSG009

Details and patient eligibility

About

The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.

Full description

Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.

Enrollment: 99 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged : 20~70 years
2. World Health Organization (WHO) (Eastern Cooperative Oncology Group [ECOG]) performance status 0-2
3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
4. 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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99 participants in 1 patient group

docetaxel/gemcitabine

Experimental group

Description:

All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion)

Treatment:

Drug: docetaxel

Drug: gemcitabine