Status:
COMPLETED
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Lead Sponsor:
University of Colorado, Denver
Conditions:
Breast Cancer
Stage II Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause ...
Detailed Description
This study will develop preliminary data regarding the efficacy and safety of exemestane in the preoperative treatment of postmenopausal women with ER+ or PR+ tumors. This trial is also designed to de...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed breast cancer
- ER positive (+)
- Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated
- Clinical stage II/III
- Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year
- Newly diagnosed
- Patients with prior non-breast malignancies are eligible if they have been disease free for \>= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization
- Serum creatinine =\< 1.5 x institutional upper limit of normal (ULN)
- Hemoglobin within normal limits for institution
- Absolute granulocyte count \>= 1500
- Platelet count \>= 100,000
- Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =\< 2.5 x ULN
- Total bilirubin \< 2 x ULN for institution
- Alkaline phosphatase \< 2 x the ULN
Exclusion
- Completely resected
- Prior hormone or chemotherapy
- Unable to take oral medication
- Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01831076
Start Date
April 1 2002
End Date
January 6 2022
Last Update
March 3 2022
Active Locations (1)
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1
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045