Mode
Text Size
Log in / Sign up
Phase 2 Completed N=180 Randomized Double-blind Prevention

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

Back to search