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Goserelin/Letrozole in Premenopausal Patients vs Letrozole Alone in Postmenopausal Patients With MBC

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00532272
First received: September 19, 2007
Last updated: June 24, 2011
Last verified: September 2007
  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
Metastatic Breast Cancer
Drug: Letrozole ,Goserelin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: October 2005
Study Completion Date: August 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: letrozole
letrozole(2.5mg orally daily)
Drug: Letrozole ,Goserelin
Letrozole 2.5mg qd. Goserlin 3.6mg monthly(premenopausal)
Other Names:
  • Femara
  • Zoladex
Active Comparator: goserelin plus letrozole
goserelin (3.6mg subcutaneously every 28 days) plus letrozole(2.5mg orally daily)
Drug: Letrozole ,Goserelin
Letrozole 2.5mg qd. Goserlin 3.6mg monthly(premenopausal)
Other Names:
  • Femara
  • Zoladex

  Show Detailed Description

  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 IHC 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532272

Locations
Korea, Republic of
National Cancer Center
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

Responsible Party: CENTER FOR BREAST CANCER, NATIONAL CANCER CENTER
ClinicalTrials.gov Identifier: NCT00532272     History of Changes
Other Study ID Numbers: NCCCTS-05-149
Study First Received: September 19, 2007
Last Updated: June 24, 2011
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014