Phase 2
Completed N=180
Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer
Stage 0 Breast Cancer AJCC v6 and v7 · Stage I Breast Cancer AJCC v7 · Stage IA Breast Cancer AJCC v7 · Stage IB Breast Cancer AJCC v7
Source: ClinicalTrials.gov NCT02598557 ↗
Enrolled (actual)
180
Serious AEs
0.6%
Results posted
Aug 2023
Primary outcomePrimary: Percent Change in Time of Circulating Estradiol SPE in Each Arm — -89; -85; -60 percent change
Summary
This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Time of Circulating Estradiol SPE in Each Arm |
-89; -85; -60 | — |
| SECONDARY Percent Change in Time of Circulating Estradiol LLE in Each Arm |
-96; -91; -72 | — |
| SECONDARY Percent Change of Circulating Estrone SPE |
-93; -89; -73 | — |
| SECONDARY Percent Change of Circulating Estrone LLE |
-99; -96; -78 | — |
| SECONDARY Percent Change of Circulating Total Estrone |
-95; -94; -76 | — |
| SECONDARY Percent Change of Circulating Estrone Sulfate |
-96; -95; -75 | — |
| SECONDARY Percent Change of Circulating Androstenedione |
0; 11; 11 | — |
| SECONDARY Percent Change of Circulating Testosterone |
-19; 0; 0 | — |
| SECONDARY Percent Change of Circulating Testosterone CLIA |
10; 0; 6 | — |
| SECONDARY Percent Change of Circulating SHBG |
-29; -15; -5.5 | — |
| SECONDARY Percent Change of Circulating Total Cholesterol |
-4; -5; -1 | — |
| SECONDARY Percent Change of Circulating HDL Cholesterol |
-14; -3; -2 | — |
| SECONDARY Percent Change of Circulating LDL Cholesterol |
-1; 0; 0 | — |
| SECONDARY Percent Change of Circulating Triglycerides |
-7; -1; 5 | — |
| SECONDARY Percent Change of Circulating Insulin |
3; 9; 4 | — |
| SECONDARY Percent Change of Serum Glucose |
-1; 1; -2 | — |
| SECONDARY Percent Change of HOMA IR |
8; 15; 6 | — |
| SECONDARY Percent Change of Circulating Adiponectin |
-12; -3; -1 | — |
| SECONDARY Percent Change of Circulating Leptin |
-16; -5; -4 | — |
| SECONDARY Exemestane Blood Concentration at Surgery |
3217; 513; 24 | — |
| SECONDARY 17-OH Exemestane Blood Concentration at Surgery |
1069; 196; 4 | — |
| SECONDARY Change of ER Expression (Cancer Tissue), Central Review |
0; 0; 0 | — |
| SECONDARY Change of PgR Expression (Cancer Tissue), Central Review |
-17; -9; -7 | — |
| SECONDARY Change of Ki67% Expression (Cancer Tissue), Central Review |
-7.5; -5; -4 | — |
| SECONDARY Change of Ki67% Expression (Adjacent Non Cancer Tissue), Central Review |
0; 0; 0 | — |
| SECONDARY Estradiol Tissue Concentration at Surgery |
15.5; 17.1; 128.8; 15.5; 15.5; 15.5 | — |
| SECONDARY Estrone Tissue Concentration at Surgery |
8.7; 28.1; 138.9; 17.4; 37.8; 140.5 | — |
| SECONDARY Androstenedione Tissue Concentration at Surgery |
6864; 5314; 5564; 10251; 12366; 10580 | — |
| SECONDARY Testosterone Tissue Concentration at Surgery |
395; 396; 453; 436; 464; 399 | — |
| SECONDARY Exemestane Tissue Concentration at Surgery |
3807; 44; 44; 17485; 435; 44 | — |
| SECONDARY 17 OH Exemestane Tissue Concentration at Surgery |
338; 65; 65; 1343; 65; 65 | — |
| SECONDARY Change in MenQoL Questionnaire Score |
0.41; 0.28; 0.51; -0.19; 0.06; -0.06 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women (postmenopausal: age >= 60 years, or amenorrhea >= 12 months, or bilateral oophorectomy, or - in women with hysterectomy only - follicle stimulating hormone [FSH] in the menopausal levels as per local institutional guidelines if = 10%) primary breast cancer stage cT0-2, cN0-1, Mx; women with larger tumors who refuse chemotherapy (chemo) and/or endocrine neoadjuvant therapy can be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status = = 70%)
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 100,000/microliter
- Total bilirubin = = 2 years prior to enrollment are eligible for the trial
- Women who are planned to receive neoadjuvant therapy
- Participants may not be receiving investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Other co-existing invasive malignancies (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization
- History of severe osteoporosis (T score =< -4 either spine or hip), or presence of vertebral fracture
- Use of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
- Use of any chemopreventive agents (selective estrogen receptor modulators [SERM]) in the last 3 months
- Concomitant use of CYP3A4 inducer medication (rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's wort)
Data sourced from ClinicalTrials.gov (NCT02598557). 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. Informational only — not medical advice.