Browse EPPT > MDA2014-04-01
Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer: A Randomized Presurgical Trial

The following datasets contain the data available for EPPT MDA2014-04-01. The description and documentation for each file is listed below. SAS7bdat and CSV versions of the actual data will be available to CDAS projects approved to use this study's data.

Analysis Datasets

Files	Description
Data Dictionary (PDF - 1.3 MB)	1. The Enhanced Person dataset contains all relevant information from every dataset received (except adverse dataset). Each record represents one participant and contains updated variable names, formats, and labels. All information coming from non-person-based datasets has been converted into a person-based format.
Data Dictionary (PDF - 47.1 KB)	2. The Adverse Events dataset contains adverse events that occurred during the study.

Raw Datasets

These 49 datasets contain the raw form data received, excluding PII.

Show these datasets

Files	Description
Data Dictionary (PDF - 52.5 KB)	1. The Adverse Events dataset contains adverse events that occurred during the study.
Data Dictionary (PDF - 44.2 KB)	2. The AE and Conmed Evaluation Form dataset contains ae and conmed evaluation form
Data Dictionary (PDF - 41.8 KB)	3. The Agent Interruption Form dataset contains agent interruption form
Data Dictionary (PDF - 57.4 KB)	4. The Alcohol Assessment Baseline dataset contains alcohol assessment - baseline
Data Dictionary (PDF - 46.6 KB)	5. The Baseline Medical/Surgical Histroy dataset contains baseline medical/surgical history body systems
Data Dictionary (PDF - 45.1 KB)	6. The Baseline Medical/Surgical Histroy Other Symptoms dataset contains baseline medical/surgical history other systems
Data Dictionary (PDF - 42.2 KB)	7. The Baseline Symptoms dataset contains baseline symptoms
Data Dictionary (PDF - 49.7 KB)	8. The Clinical Laboratory Data Blood Chemistry dataset contains clinical laboratory data blood chemistry
Data Dictionary (PDF - 46.2 KB)	9. The Clinical Laboratory Data Hematology dataset contains clinical laboratory data hematology
Data Dictionary (PDF - 44.4 KB)	10. The Clinical Laboratory Data Other Lab Tests dataset contains clinical laboratory data other lab tests
Data Dictionary (PDF - 40.0 KB)	11. The Comments dataset contains comments
Data Dictionary (PDF - 40.5 KB)	12. The Compliance Drug Labels dataset contains compliance drug labels
Data Dictionary (PDF - 44.8 KB)	13. The Concomitant Medications dataset contains concomitant medications
Data Dictionary (PDF - 54.6 KB)	14. The Demography Payment Method dataset contains registration part ii: demography participant method of payment
Data Dictionary (PDF - 54.3 KB)	15. The Demography Race dataset contains registration part ii: demography race
Data Dictionary (PDF - 55.0 KB)	16. The Drug Compliance Wallet 1 Blister 1 dataset contains drug compliance wallet 1 blister 1
Data Dictionary (PDF - 55.8 KB)	17. The Drug Compliance Wallet 1 Blister 2 dataset contains drug compliance wallet 1 blister 2
Data Dictionary (PDF - 55.0 KB)	18. The Drug Compliance Wallet 1 Blister 3 dataset contains drug compliance wallet 1 blister 3
Data Dictionary (PDF - 55.8 KB)	19. The Drug Compliance Wallet 2 Blister 1 dataset contains drug compliance wallet 2 blister 1
Data Dictionary (PDF - 55.0 KB)	20. The Drug Compliance Wallet 2 Blister 2 dataset contains drug compliance wallet 2 blister 2
Data Dictionary (PDF - 55.0 KB)	21. The Drug Compliance Wallet 2 Blister 3 dataset contains drug compliance wallet 2 blister 3
Data Dictionary (PDF - 41.3 KB)	22. The Eligibility Verification dataset contains eligibility verification
Data Dictionary (PDF - 43.8 KB)	23. The Exclusion Criteria 10a2_8_9_2017 dataset contains exclusion criteria: v10a2_8_9_2017
Data Dictionary (PDF - 43.0 KB)	24. The Exclusion Criteria 11a3_2_10_2018 dataset contains exclusion criteria: v11a3_2_10_2018
Data Dictionary (PDF - 42.6 KB)	25. The Exclusion Criteria prev10a2 dataset contains exclusion criteria: prev10a2
Data Dictionary (PDF - 43.2 KB)	26. The Inclusion Criteria 10a2_8_9_2017 dataset contains inclusion criteria: v10a2_8_9_2017
Data Dictionary (PDF - 43.1 KB)	27. The Inclusion Criteria 11a3_2_10_2018 dataset contains inclusion criteria: v11a3_2_10_2018
Data Dictionary (PDF - 42.3 KB)	28. The Inclusion Criteria prev10a2 dataset contains inclusion criteria: prev10a2
Data Dictionary (PDF - 47.1 KB)	29. The Intervention Administration dataset contains intervention administration (blinded study)
Data Dictionary (PDF - 61.8 KB)	30. The Local Breast Tissue Histology - Group dataset contains local breast tissue histology hrt group
Data Dictionary (PDF - 61.6 KB)	31. The Local Breast Tissue Histology - Her2 Amplification dataset contains local breast tissue histology hrt her2 amplification
Data Dictionary (PDF - 62.6 KB)	32. The Local Breast Tissue Histology - Her2 Receptor dataset contains local breast tissue histology hrt her2 receptor
Data Dictionary (PDF - 47.0 KB)	33. The Off Study dataset contains off study
Data Dictionary (PDF - 60.8 KB)	34. The Physical Exam Other Systems dataset contains physical exam other systems
Data Dictionary (PDF - 63.3 KB)	35. The Physical Exam System Status dataset contains physical exam body system
Data Dictionary (PDF - 45.7 KB)	36. The Pill Diary dataset contains exemestane pill diary
Data Dictionary (PDF - 47.7 KB)	37. The Quality of Life Questionnaire dataset contains the menopause-specific quality of life questionnaire
Data Dictionary (PDF - 50.0 KB)	38. The Randomization dataset contains randomization
Data Dictionary (PDF - 44.1 KB)	39. The Screening dataset contains screening
Data Dictionary (PDF - 42.1 KB)	40. The Screening Registration dataset contains screening registration (used at screening visit - european sites only)
Data Dictionary (PDF - 44.8 KB)	41. The Specimen Acquisition Blood Baseline dataset contains specimen acquisition blood (used for baseline)
Data Dictionary (PDF - 45.0 KB)	42. The Specimen Acquisition Blood Final Visit dataset contains specimen acquisition blood (used for final visit)
Data Dictionary (PDF - 44.2 KB)	43. The Specimen Acquisition Tissue dataset contains specimen acquisition tissue (used at baseline and surgery)
Data Dictionary (PDF - 52.9 KB)	44. The Specimen Shipping Form - Blood dataset contains study specimen shipping form - blood
Data Dictionary (PDF - 53.7 KB)	45. The Specimen Shipping Form - Tissue dataset contains study specimen shipping form - tissue
Data Dictionary (PDF - 48.5 KB)	46. The Telephone Contact dataset contains telephone contact
Data Dictionary (PDF - 66.2 KB)	47. The Tobacco Assessment Baseline dataset contains tobacco assessment - baseline
Data Dictionary (PDF - 38.7 KB)	48. The Unblinding dataset contains unblinding form v030719
Data Dictionary (PDF - 39.7 KB)	49. The Verification Form dataset contains verification form

Trial 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.

Participants are randomized to 1 of 3 treatment arms.

• ARM I: Participants receive exemestane orally (PO) once daily (QD) on days 1-7.
• ARM II: Participants receive exemestane PO QD on days 1, 3, and 5. Patients also receive placebo PO QD on days 2, 4, 6, and 7.
• ARM III: Participants receive exemestane PO QD on day 1 and placebo PO QD on days 2-7.

In all arms, cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Participants then undergo surgery on days 29, 36, or 43.

After completion of study treatment, patients are followed up at 20-30 days should any drug-related toxicity persists at final visit.

Target Enrollment: 300

Actual Enrollment: 230

Enrollment Statistics

Actual Registration: 230

• 180 people randomized
  • 59 in Arm I (59 out of 180 randomized): Exemestane once daily
    • 55 completed the study.
    • 2 withdrew from study.
    • 1 lost due to adverse events.
    • 1 dropped due to other reasons.
  • 58 in Arm II (58 out of 180 randomized): Exemestane three times a week
    • 56 completed the study.
    • 1 withdrew from study.
    • 1 lost due to adverse events.
  • 63 in Arm III (63 out of 180 randomized): Exemestane once weekly
    • 60 completed the study.
    • 1 withdrew from study.
    • 1 lost due to adverse events.
    • 1 dropped due to physicians decision.
• 50 people were not randomized (50 of 230 registered)

Statistical Analysis and Total Study Population Demographics:

• Age (years):
  • Mean: 64.3
  • Range: 45-82
  • Median: 64
• Height (cm):
  • Mean: 161
  • IQR: 156-165
  • Range: 146-177
  • Median: 161
• Weight (kg)
  • Mean: 76
  • IQR: 62-85
  • Range: 48-156
  • Median: 73
• Gender
  • Female: 180 (100%)

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 < 60 years old) with histologically-confirmed estrogen receptor (ER)-positive (>= 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 =< 1 (Karnofsky >= 70%)
• Leukocytes >= 3,000/microliter
• Absolute neutrophil count >= 1,500/microliter
• Platelets >= 100,000/microliter
• Total bilirubin =< 2 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN
• Serum creatinine =< 1.5 times institutional ULN
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Body mass index (BMI) < 18.5 Kg/m^2
• Previous treatment for breast cancer including chemotherapy, endocrine therapy and radiotherapy; women with prior ductal breast carcinoma in situ (DCIS) who were treated with surgery only and whose treatment ended >= 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)

Schema

The Schema is a timeline of the study. It indicates start/end points, visits expected, major testing to be done, and any other information that is crucial to understanding how the study was completed.

A total of 180 women were randomized into 1 of the 3 arms; median (IQR) age was 66 (60-71) years, 63 (60-69) years, and 65 (61-70) years in the once-daily, 3-times-weekly, and once-weekly arms, respectively. In the intention-to-treat population (n = 171), the least square mean percentage change of serum estradiol was −89%, −85%, and −60% for exemestane once daily (n = 55), 3 times weekly (n = 56), and once weekly (n = 60), respectively. The difference in estradiol percentage change between the once-daily and 3-times-weekly arms was −3.6% (P for noninferiority = .37), whereas in compliant participants (n = 153), it was 2.0% (97.5% lower confidence limit, −5.6%; P for noninferiority = .02). Among secondary end points, Ki-67 and progesterone receptor were reduced in all arms, with median absolute percentage changes of −7.5%, −5.0%, and −4.0% for Ki-67 in the once-daily, 3-times-weekly, and once-weekly arms, respectively (once daily vs 3 times weekly, P = .31; once daily vs once weekly, P = .06), and −17.0%, −9.0%, and −7.0% for progesterone receptor, respectively. Sex hormone–binding globulin and high-density lipoprotein cholesterol had a better profile among participants in the 3-times-weekly arm compared with once-daily arm. Adverse events were similar in all arms.