Phase 2
N=36
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Breast Cancer · Stage II Breast Cancer · Stage III Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01831076 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings — 23; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exemestane (Drug); Exemestane and tamoxifen (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings |
23; 0 | — |
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 the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.
Eligibility Criteria
Inclusion Criteria
- 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 = = 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01831076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.