Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer
7 other identifiers
interventional
180
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedStudy Start
First participant enrolled
December 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedResults Posted
Study results publicly available
August 22, 2023
CompletedAugust 22, 2023
August 1, 2023
2.8 years
November 5, 2015
March 31, 2023
August 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Time of Circulating Estradiol SPE in Each Arm
LS means of percent change
baseline and 4-6 weeks
Secondary Outcomes (31)
Percent Change in Time of Circulating Estradiol LLE in Each Arm
baseline and 4-6 weeks
Percent Change of Circulating Estrone SPE
baseline and 4-6 weeks
Percent Change of Circulating Estrone LLE
baseline and 4-6 weeks
Percent Change of Circulating Total Estrone
baseline and 4-6 weeks
Percent Change of Circulating Estrone Sulfate
baseline and 4-6 weeks
- +26 more secondary outcomes
Other Outcomes (1)
Proteomic Analysis
4-6 weeks
Study Arms (3)
Arm I: Exemestane 25 mg QD
EXPERIMENTALPatients receive exemestane PO QD on days 1-7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.
Arm II: Exemestane 25 TIW (exemestane, placebo)
EXPERIMENTALPatients receive exemestane PO QD on days 1, 3, and 5. Patients also receive placebo PO QD on days 2, 4, 6, and 7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.
Arm III: Exemestane 25 mg QW (exemestane, placebo)
EXPERIMENTALPatients receive exemestane PO QD on day 1 and placebo PO QD on days 2-7. Cycles repeat every 7 days for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery on days 29, 36, or 43.
Interventions
Given PO
Correlative studies
Correlative studies
Given PO
Ancillary studies
Ancillary studies
Undergo surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Galliera Hospital
Genoa, 16128, Italy
European Institute of Oncology
Milan, 20141, Italy
Related Publications (2)
Serrano D, Johansson H, Bertelsen BE, Gandini S, Mellgren G, Thomas P, Crew KD, Kumar NB, Macis D, Aristarco V, Guerrieri-Gonzaga A, Lazzeroni M, D'Amico M, Buttiron-Webber T, Briata IM, Spinaci S, Galimberti V, Vornik LA, Vilar E, Brown PH, Heckman-Stoddard BM, Szabo E, Bonanni B, DeCensi A. Drug and biomarker tissue levels in a randomized presurgical trial on exemestane alternative schedules. J Natl Cancer Inst. 2024 Dec 1;116(12):1979-1982. doi: 10.1093/jnci/djae183.
PMID: 39110531DERIVEDSerrano D, Gandini S, Thomas P, Crew KD, Kumar NB, Vornik LA, Lee JJ, Veronesi P, Viale G, Guerrieri-Gonzaga A, Lazzeroni M, Johansson H, D'Amico M, Guasone F, Spinaci S, Bertelsen BE, Mellgren G, Bedrosian I, Weber D, Castile T, Dimond E, Heckman-Stoddard BM, Szabo E, Brown PH, DeCensi A, Bonanni B. Efficacy of Alternative Dose Regimens of Exemestane in Postmenopausal Women With Stage 0 to II Estrogen Receptor-Positive Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2023 May 1;9(5):664-672. doi: 10.1001/jamaoncol.2023.0089.
PMID: 36951827DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Parijatham S. Thomas, MD., Associate Professor, Clinical Cancer Prevention
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Bernardo Bonanni
European Institute of Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 6, 2015
Study Start
December 6, 2016
Primary Completion
October 3, 2019
Study Completion
February 2, 2023
Last Updated
August 22, 2023
Results First Posted
August 22, 2023
Record last verified: 2023-08