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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


Phase 2
20 Years
70 Years
Not Enrolling
Female
Breast Cancer Stage II, Breast Cancer Stage III

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate was assessed by pathologic examination after surgery.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Young Jin Suh, M.D. Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, the Catholic university of Korea, St. Vincent's hospital

Authority:

Korea: Food and Drug Administration

Study ID:

KBCSG009

NCT ID:

NCT01352494

Start Date:

May 2011

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • locally advanced breast cancer
  • docetaxel
  • gemcitabine
  • Breast Neoplasms

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