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

NCT00532272 | Completed Phase 2

• 1 other identifier: NCCCTS-05-149
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  4 years

Study Arms (2)

letrozole

EXPERIMENTAL

letrozole(2.5mg orally daily)

Drug: Letrozole ,Goserelin

goserelin plus letrozole

ACTIVE COMPARATOR

goserelin (3.6mg subcutaneously every 28 days) plus letrozole(2.5mg orally daily)

Drug: Letrozole ,Goserelin

Interventions

Letrozole ,Goserelin DRUG

Letrozole 2.5mg qd. Goserlin 3.6mg monthly(premenopausal)

Also known as: Femara, Zoladex

goserelin plus letrozole; letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC)
• Positive estrogen receptor or progesterone receptor (\>grade 3/7 by modified Allred IHC score)
• Females at least 18 years of age and under 75 years
• Prior chemotherapy for adjuvant setting or metastatic disease is allowed if the number of chemotherapy is ≤ 3.
• Prior adjuvant antiestrogen therapy is allowed, provided that had not been received within 3 weeks before the entry of the study
• Prior adjuvant aromatase inhibitor therapy is allowed if the agent had not been given within one year of the entry.
• Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
• No other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in the study.
• Performance status of 0, 1 and 2 on the ECOG criteria.
• 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.
• Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible.
• Estimated life expectancy of at least 12 weeks.
• Compliant patient who can be followed-up adequately.
• 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.
• Informed consent from patient or patient's relative.

You may not qualify if:

• Previous chemotherapy more than 3 including adjuvant therapy.
• 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).

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Goserelin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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

• Jungsil Ro, MD,PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 20, 2007
• Study Start: October 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: August 1, 2010
• Last Updated: June 27, 2011

Record last verified: 2007-09

Locations

KR (1)