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Phase 2 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 · Stage II Breast Cancer AJCC v6 and v7

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

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

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)
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.

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