Phase 2
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 · Stage II Breast Cancer AJCC v6 and v7
Bottom Line
View on ClinicalTrials.gov: NCT02598557 ↗Enrolled (actual)
180
Serious AEs
0.6%
Results posted
Aug 2023
Primary outcome: Primary: Percent Change in Time of Circulating Estradiol SPE in Each Arm — -89; -85; -60 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exemestane (Drug); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other); Placebo Administration (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Therapeutic Conventional Surgery (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2019
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 | — |
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.
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.