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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Tianjin Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT00488722
First received: June 19, 2007
Last updated: June 25, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Drug: Zoladex

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tianjin Medical University:

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

Secondary Outcome Measures:
  • To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: CBR, downstaging rates in tumor size and axillary lymph node -To evaluate the safety of concurrent Zoladex and CEF as neoadjuvant regimen

Study Start Date: April 2007
Estimated Study Completion Date: March 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488722

Contacts
Contact: ZHANG SHENG, DOCTOR 86-022-23340123 ext 2901

Locations
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: ZHANG SHENG, DOCTOR     86-022-23340123 ext 2901        
Contact: ZHANG SHENG, DORTOR     86-022-23340123 ext 2901        
Principal Investigator: ZHANG JIN, PROFESSOR            
Sponsors and Collaborators
Tianjin Medical University
Investigators
Principal Investigator: ZHNAG JIN, PROFESSOR TIANJIN CANCER HOSPITAL
Principal Investigator: ZHANG JIN, PROFESSOR TAINJIN CANCER HOSPITAL
  More Information

No publications provided by Tianjin Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00488722     History of Changes
Other Study ID Numbers: jzhang
Study First Received: June 19, 2007
Last Updated: June 25, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013