Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

NCT00461344

Ductal Carcinoma

TERMINATED PHASE2

Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

NCT00191438

Breast Neoplasms

COMPLETED PHASE3

Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine

NCT00294385

Breast Cancer

COMPLETED PHASE3

Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

NCT00191243

Breast Cancer

COMPLETED PHASE2

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

NCT01351597

Recurrent Breast Cancer Metastatic Breast Cancer

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Stage II Breast Cancer Stage III

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

docetaxel/gemcitabine

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

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles

gemcitabine

Intervention Type DRUG

gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

docetaxel

docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles

Intervention Type DRUG

gemcitabine

gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Doxotel® Gemcibine®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No