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Goserelin Plus Letrozole in Premenopausal Patients Versus Letrozole Alone in Postmenopausal Patients With Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Center, Korea, September 2007
First Received: September 19, 2007   No Changes Posted
Sponsored by: National Cancer Center, Korea
Information provided by: National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00532272
  Purpose

Primary objective is to evaluate the response rates and clinical benefits of letrozole + goserelin in premenopausal patients versus letrozole alone in postmenopausal patients with metastatic breast cancer as first line hormonal therapy


Condition Intervention Phase
Breast Cancer
Metastatic
Drug: Letrozole
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Goserelin Letrozole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Phase II Non-Randomized, Parallel Group Study of Goserelin or Leuprorelin Plus Letrozole in Premenopausal Patients Versus Letrozole Alone in Postmenopausal Patients With Metastatic Breast Cancer

Further study details as provided by National Cancer Center, Korea:

Estimated Enrollment: 70
Study Start Date: October 2005
Estimated Study Completion Date: October 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC)
  2. Positive estrogen receptor or progesterone receptor (>grade 3/7 by modified Allred score)
  3. Females at least 18 years of age and under 75 years
  4. Prior chemotherapy for adjuvant setting or metastatic disease is allowed if the number of chemotherapy is ≤ 3.
  5. Prior adjuvant antiestrogen therapy is allowed, provided that had not been received within 3 weeks before the entry of the study
  6. Prior adjuvant aromatase inhibitor therapy is allowed if the agent had not been given within one year of the entry.
  7. Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
  8. No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in the study.
  9. Performance status of 0, 1 and 2 on the ECOG criteria.
  10. Clinically measurable disease, defined as unidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by x-ray, CT scan, MRI, or physical examination.
  11. Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible.
  12. Estimated life expectancy of at least 12 weeks.
  13. Compliant patient who can be followed-up adequately.
  14. Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic (bilirubin level 1.8 mg/dL, AST, ALT 2.0xULN, albumin 2.5 g/dL), and renal (creatinine concentration 1.5 mg/dL) function.
  15. Informed consent from patient or patient's relative.
  16. Childbearing women should use non-hormonal contraceptive method.

Exclusion Criteria:

  1. Previous chemotherapy more than 3 including adjuvant therapy.
  2. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532272

Contacts
Contact: Jungsil Ro, MD, PhD 82-31-920-1610 jungsro@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jungsil Ro, MD,PhD National Cancer Center, Korea
  More Information

No publications provided

Study ID Numbers: NCCCTS-05-149
Study First Received: September 19, 2007
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00532272     History of Changes
Health Authority: South Korea: Institutional Review Board

Study placed in the following topic categories:
Skin Diseases
Goserelin
Breast Neoplasms
Letrozole
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Breast Neoplasms
Enzyme Inhibitors
Letrozole
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009