Breast Cancer
Conditions
Keywords
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
Brief 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.
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.
Interventions
DRUGZoladex
Sponsors
Tianjin Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of concurrent Zoladex and CEF as neoadjuvant regimen in terms of: ORR(CR+PR) and PCR | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactZHANG SHENG, DOCTOR
Outcome results
None listed