|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Primary Purpose: Treatment |
| 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: | 610 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | August 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral exemestane once daily for up to 16-18 weeks.
|
Drug: exemestane
Given orally
|
|
Experimental: Arm II
Patients receive oral letrozole once daily for up to 16-18 weeks.
|
Drug: letrozole
Given orally
|
|
Experimental: Arm III
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 treating physician, 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, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Doctor's Hospital of Laredo | |
| Laredo, Texas, United States, 78041 | |
| Study Chair: | Matthew J. Ellis, MD, PhD, FRCP | Washington University Siteman Cancer Center |
| Investigator: | John A. Olson, MD, PhD | Duke Cancer Institute |
| Principal Investigator: | Kevin S. Hughes, MD, FACS | Massachusetts General Hospital |
More Information
| Responsible Party: | David M. Ota, American College of Surgeons Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00265759 History of Changes |
| Other Study ID Numbers: | CDR0000456382, ACOSOG-Z1031, CALGB-ACOSOG-Z1031 |
| Study First Received: | December 14, 2005 |
| Last Updated: | December 23, 2011 |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer estrogen receptor-positive breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogens Exemestane Letrozole Anastrozole Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |