CClinicalTrials.gg
Status unknownNCT00488722Updated Jun 26, 2007

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

An interventional study of Zoladex in Breast Cancer, sponsored by Tianjin Medical University. Status unknown at 1 site in China. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2007-06-26.

Sponsored by Tianjin Medical University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Allocation
Non-randomized
Ages
25 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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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
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 46 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugZoladex
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Tianjin Cancer Hospital
    Tianjin, Tianjin 300060, China
    • ZHANG SHENG, DOCTOR · Contact · 86-022-23340123
    • ZHANG SHENG, DORTOR · Contact · 86-022-23340123
    • ZHANG JIN, PROFESSOR · Principal investigator
    Recruiting
08

References and documents

Publications

  • Zhang S, Zhang C, Liu J, Qin L, Cui S, Zhang J. A Phase II trial of Zoladex combined with CEF chemotherapy as neoadjuvant therapy in premenopausal women with hormone-responsive, operable breast cancer. Med Oncol. 2012 Jun;29(2):479-85. doi: 10.1007/s12032-011-9883-2. Epub 2011 Mar 6. PubMed 21380781 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00488722
Lead sponsor
Tianjin Medical University
First posted
Jun 20, 2007
Start date
Apr 2007
Completion
Mar 2009
Last update
Jun 26, 2007

Study contacts

ZHANG SHENG, DOCTOR
Contact
86-022-23340123 ext. 2901
ZHNAG JIN, PROFESSOR
principal investigator · Tianjin Cancer Hospital
ZHANG JIN, PROFESSOR
principal investigator · TAINJIN CANCER HOSPITAL

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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