Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01352494

Acronym

NeoTG

Enrollment

Registered

2011-05-12

Start date

2011-05-31

Completion date

2015-05-31

Last updated

2011-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Stage II, Breast Cancer Stage III

Keywords

locally advanced breast cancer, docetaxel, gemcitabine

Brief summary

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.

Detailed 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.

Interventions

DRUGdocetaxel

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

DRUGgemcitabine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Complete remission rate was assessed by pathologic examination after surgery.	2 years

Secondary

Measure	Time frame
Type of surgery (Breast Conserving Rate)	6 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	1 year
progression free survival	2 years
quality of life	2 years

Countries

South Korea

Contacts

Primary ContactKu Sang Kim, M.D.

ideakims@gmail.com82-31-219-5200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026