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

NCT00488722 | Unknown DMC

• 1 other identifier: jzhang
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

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

Outcome Measures

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

Interventions

Zoladex DRUG

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of informed consent
• Pathological confirmation of breast cancer
• Tumor stage(TNM):T2-4bN0-3M0
• ER(+) and/or PR(+).
• Premenopausal woman.
• Age≥40 years
• Measurable disease as per RECIST criteria
• Karnofsky≥70
• Labratory criteria:
• PLT≥100\*109/L
• WBC≥4000/mm3
• HGB≥10g/dl
• ALT and AST\<2\*ULN

You may not qualify if:

• Presence of metastatic disease.
• Inflammatory breast cancer.
• Bilateral breast cancer.
• previous chemotherapy or hormonal therapyfor current breast neoplasm.
• other malignant tumor (concurrent or previous).
• Pregnant woman.
• Hypersensitive to any drug in CEF regimen or any ingredient of Zoladex.
• Any severe systemic disease contraindicating chemotherapy.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 21380781 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• ZHNAG JIN, PROFESSOR

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

• ZHANG JIN, PROFESSOR

  TAINJIN CANCER HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHANG SHENG, DOCTOR

CONTACT

86-022-23340123

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: April 1, 2007
• Study Completion: March 1, 2009
• Last Updated: June 26, 2007

Record last verified: 2007-04

Locations

CN (1)