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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012025 |
Purpose
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells.
PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: fulvestrant |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy |
| Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years or until disease progression. After disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 41-94 patients will be accrued for this study within 10 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast
At least 1 measurable lesion
Nonmeasurable disease includes the following:
Disease progression after prior third-generation aromatase inhibitor (e.g., anastrozole, exemestane, letrozole, or vorozole)
Failed no more than 1 prior additive hormonal therapy (e.g., aromatase inhibitor with or without tamoxifen)
Evidence of hormone sensitivity as defined by:
Postmenopausal as defined by one of the following:
Hormone receptor status:
Estrogen-receptor and/or progesterone-receptor positive
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 25 Study Locations| Study Chair: | James N. Ingle, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000068473, NCCTG-N0032 |
| Study First Received: | March 3, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012025 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Estrogens Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Hormones Recurrence Estrogen Receptor Modulators Aromatase Inhibitors Breast Diseases |
|
Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |