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A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer


N/A
25 Years
50 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer


It has been found that many breast cancers are hormone dependent and that hormonal therapy
by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has
proven beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing
hormone releasing hormone analogue, can offer efficient estrogen suppression as well. It can
induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some
studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal
hormone dependent breast cancer in both adjuvant and metastatic settings. Few data is
available on Zoladex in neoadjuvant treatment for breast cancer In our departments,
neoadjuvant CEF regimen is of general practice, and a preliminary study is designed to
investigate whether adding Zoladex into neoadjuvant CEF could further improve results in
hormone responsive breast cancer.


Inclusion Criteria:



1. Provision of informed consent

2. Pathological confirmation of breast cancer

3. Tumor stage(TNM):T2-4bN0-3M0

4. ER(+) and/or PR(+).

5. Premenopausal woman.

6. Age≥40 years

7. Measurable disease as per RECIST criteria

8. Karnofsky≥70

9. Labratory criteria:

- PLT≥100*109/L

- WBC≥4000/mm3

- HGB≥10g/dl

- ALT and AST<2*ULN

Exclusion Criteria:

1. Presence of metastatic disease.

2. Inflammatory breast cancer.

3. Bilateral breast cancer.

4. previous chemotherapy or hormonal therapyfor current breast neoplasm.

5. other malignant tumor (concurrent or previous).

6. Pregnant woman.

7. Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.

8. Any severe systemic disease contraindicating chemotherapy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: ORR(CR+PR) and PCR

Principal Investigator

ZHNAG JIN, PROFESSOR

Investigator Role:

Principal Investigator

Investigator Affiliation:

TIANJIN CANCER HOSPITAL

Authority:

China: Food and Drug Administration

Study ID:

jzhang

NCT ID:

NCT00488722

Start Date:

April 2007

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • To observe the biological changes under concurrent Zoladex and CEF as neoadjuvant regimen with respect to the ER,PR,cerbB-2 status before and after therapy
  • Breast Neoplasms

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