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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

NCT ID: NCT00488722

Last Updated: 2007-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Zoladex

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University

OTHER

Sponsor Role lead

Principal Investigators

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ZHNAG JIN, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

Tianjin Cancer Hospital

ZHANG JIN, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

TAINJIN CANCER HOSPITAL

Locations

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Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ZHANG SHENG, DOCTOR

Role: CONTACT

86-022-23340123 ext. 2901

Facility Contacts

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ZHANG SHENG, DOCTOR

Role: primary

86-022-23340123 ext. 2901

ZHANG SHENG, DORTOR

Role: backup

86-022-23340123 ext. 2901

References

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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.

Reference Type DERIVED
PMID: 21380781 (View on PubMed)

Other Identifiers

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jzhang

Identifier Type: -

Identifier Source: org_study_id