Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-… (NCT02598557) | Clinical Trial Compass
CompletedPhase 2
Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer
United States, Italy180 participantsStarted 2016-12-06
Plain-language 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.
Who can participate
Age range75 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 receiv…
What they're measuring
1
Percent Change in Time of Circulating Estradiol SPE in Each Arm