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
Information source: Tianjin Medical University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Zoladex (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Tianjin Medical University Official(s) and/or principal investigator(s):
ZHNAG JIN, PROFESSOR, Principal Investigator, Affiliation: TIANJIN CANCER HOSPITAL
ZHANG JIN, PROFESSOR, Principal Investigator, Affiliation: TAINJIN CANCER HOSPITAL
Overall contact:
ZHANG SHENG, DOCTOR, Phone: 86-022-23340123, Ext: 2901
Summary
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: ORR(CR+PR) and PCR
Secondary outcome: 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
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
Minimum age: 25 Years.
Maximum age: 50 Years.
Gender(s): Female.
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.
Locations and Contacts
ZHANG SHENG, DOCTOR, Phone: 86-022-23340123, Ext: 2901
Tianjin Cancer Hospital, Tianjin, Tianjin 300060, China; Recruiting
ZHANG SHENG, DOCTOR, Phone: 86-022-23340123, Ext: 2901
ZHANG SHENG, DORTOR, Phone: 86-022-23340123, Ext: 2901
ZHANG JIN, PROFESSOR, Principal Investigator
Additional Information
Starting date: April 2007
Last updated: June 25, 2007
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