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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Novartis |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00549822 |
The purpose of this research study is to study the effects of using aromatase inhibitor (AI) therapy intermittently on participants with breast cancer. AIs are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have become resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy, and that increasing estrogen levels even slightly by stopping AI therapy may inhibit the breast cancer cells.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Clinical Trial of Intermittent Letrozole Therapy in Postmenopausal Women With CA 15-3 Positive, Hormone Receptor Positive, Metastatic Breast Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paula D Ryan, MD, Phd | 617-726-5046 | pdryan@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Paula D. Ryan, MD, PhD | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Leroy Parker, MD |
Principal Investigator: | Paula D. Ryan, MD, PhD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Paula Ryan, MD, PhD ) |
Study ID Numbers: | 07-109 |
Study First Received: | October 24, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00549822 |
Health Authority: | United States: Institutional Review Board |
aromatase inhibitor CA 15-3 Hormone receptor positive |
Skin Diseases Breast Neoplasms Letrozole Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |