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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey American College of Surgeons |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00698971 |
Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anti-cancer drugs) is commonly given before surgery to shrink breast tumors. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.
In this research study 3 drugs called hormone therapy (a drug used to lower the level of the hormone estrogen) will be tested. The hormone therapies being tested in this study are exemestane, anastrozole, letrozole.
The purpose of this study is to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: exemestane Drug: letrozole Drug: anastrozole |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer |
Estimated Enrollment: | 375 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator
Patients receive oral exemestane once daily for 16-18 weeks.
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Drug: exemestane
Patients receive oral exemestane once daily for 16-18 weeks.
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II: Active Comparator
Patients receive oral letrozole once daily for 16-18 weeks.
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Drug: letrozole
Patients receive oral letrozole once daily for 16-18 weeks.
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III: Active Comparator
Patients receive oral anastrozole once daily for 16-18 weeks.
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Drug: anastrozole
Patients receive oral anastrozole once daily for 16-18 weeks.
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Clinically staged, as documented by the operating surgeon, as 1 of the following:
No distant metastasis (M1)
PATIENT CHARACTERISTICS:
Patient must be postmenopausal, verified by 1 of the following:
If patient is a cancer survivor, all of the following criteria must be met:
PRIOR CONCURRENT THERAPY:
Contact: Robert Wieder, MD, PHD | 9739724871 | WIEDERRO@UMDNJ.EDU |
Contact: Yasmeen S Barber, BA | 9739727789 | barberys@UMDNJ.EDU |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | Recruiting |
Newark, New Jersey, United States, 07101-1709 | |
Contact: Yasmeen S Barber, BA 973-972-7789 barberys@umdnj.edu | |
Principal Investigator: Robert Wieder, MD, PhD | |
Sub-Investigator: Lillian Pliner, MD | |
Sub-Investigator: Margarette Bryan, MD | |
Sub-Investigator: Kevin Clarke, MD | |
Sub-Investigator: Meera Hameed, MD | |
Sub-Investigator: Dolly Razdan, MD | |
Sub-Investigator: Charles Cathcart, MD |
Study Chair: | Matthew J. Ellis,, MB, PhD, FRCP | Washington University in St. Louis, Missouri |
Responsible Party: | American College of Surgeons Oncology Group ( Matthew J. Ellis, MB, PhD, FRCP, Study Chair ) |
Study ID Numbers: | 0120070323 |
Study First Received: | June 12, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00698971 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Estrogens Anastrozole Antineoplastic Agents, Hormonal Skin Diseases Breast Neoplasms |
Letrozole Exemestane Aromatase Inhibitors Breast Diseases |
Anastrozole Antineoplastic Agents, Hormonal Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Letrozole Enzyme Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Exemestane Aromatase Inhibitors Breast Diseases |