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| Sponsor: | American College of Surgeons |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00265759 |
Purpose
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: anastrozole Drug: exemestane Drug: letrozole |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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: | 567 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | August 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral exemestane once daily for up to 16-18 weeks.
|
Drug: exemestane
Given orally
|
|
Arm II: Experimental
Patients receive oral letrozole once daily for up to 16-18 weeks.
|
Drug: letrozole
Given orally
|
|
Arm III: Experimental
Patients receive oral anastrozole once daily for up to 16-18 weeks.
|
Drug: anastrozole
Given orally
|
Show Detailed Description
Eligibility| 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)
Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8
PATIENT CHARACTERISTICS:
Patient must be postmenopausal, verified by 1 of the following:
No other malignancies within the past 5 years, except for successfully treated cervical carcinoma in situ; lobular carcinoma in situ of the breast; contralateral ductal carcinoma in situ that was treated with mastectomy or lumpectomy with radiotherapy (without tamoxifen); or non-melanoma skin cancer with no evidence of recurrence
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Indiana | |
| Community Hospital | Recruiting |
| Munster, Indiana, United States, 46321 | |
| Contact: Erwin L. Robin, MD 219-836-2860 | |
| United States, Iowa | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| United States, Maryland | |
| Cancer Institute at St. Joseph Medical Center | Recruiting |
| Towson, Maryland, United States, 21204 | |
| Contact: Michael J. Schultz 410-337-1000 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Matthew J. Ellis, MD, PhD, FRCP 314-747-7502 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| Contact: James A. Reilly, MD 402-354-8163 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| United States, New Mexico | |
| Hematology Oncology Associates, PC | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| Contact: Anne M. Wallace, MD 858-822-6193 | |
| New Mexico Cancer Care Associates | Recruiting |
| Santa Fe, New Mexico, United States, 87505 | |
| Contact: Clinical Trials Office - New Mexico Cancer Care Associates 505-955-7910 | |
| New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87109 | |
| Contact: Richard O. Giudice 505-842-8171 | |
| Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | Recruiting |
| Albuquerque, New Mexico, United States, 87110 | |
| Contact: Anne M. Wallace, MD 858-822-6193 | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, Ohio | |
| McDowell Cancer Center at Akron General Medical Center | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Daniel P. Guyton, MD 330-344-6234 | |
| United States, Pennsylvania | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Recruiting |
| Allentown, Pennsylvania, United States, 18105 | |
| Contact: Paul J. Mosca 610-402-0500 | |
| York Cancer Center at Apple Hill Medical Center | Recruiting |
| York, Pennsylvania, United States, 17405 | |
| Contact: Thomas L. Bauer, MD 302-623-4530 | |
| United States, Texas | |
| Dallas Surgical Group | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Peter D. Beitsch, MD, FACS 972-566-8039 | |
| Doctor's Hospital of Laredo | Recruiting |
| Laredo, Texas, United States, 78041 | |
| Contact: Gary W. Unzeitig, MD 956-726-3691 | |
| United States, Wisconsin | |
| Franciscan Skemp Healthcare - La Crosse Campus | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Mary Kathleen Christian 608-785-0940 | |
| Study Chair: | Matthew J. Ellis, MD, PhD, FRCP | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| Investigator: | John A. Olson, MD, PhD | Duke University |
| Principal Investigator: | Kevin S. Hughes, MD, FACS | Massachusetts General Hospital |
More Information
| Responsible Party: | American College of Surgeons Oncology Group ( David M. Ota ) |
| Study ID Numbers: | CDR0000456382, ACOSOG-Z1031, CALGB-ACOSOG-Z1031 |
| Study First Received: | December 14, 2005 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00265759 History of Changes |
| Health Authority: | Unspecified |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer estrogen receptor-positive breast cancer |
|
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 |