AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8NCT05568472

Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study

A study testing Best Practice, Biospecimen Collection and Endocrine Drug Therapy in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by SWOG Cancer Research Network at 490 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Best Practice, Biospecimen Collection and Endocrine Drug Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
565 participants
Where
490 sitesin 2 countries
Study dates
29 Mar 2023to 1 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation
  • Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following:
  • had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis, or
  • had a serum or plasma estradiol and/or follicle stimulating hormone (FSH) concentration consistent with premenopausal status (based on institutional standards) within the 12 months before breast cancer diagnosis or when checked after breast cancer diagnosis
  • Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole; within 14 days prior to randomization or be planning to start initial treatment with standard of care oral ET within 14 days after randomization
  • Participants who currently have ovarian function (estradiol above the postmenopausal range) must be planning to undergo ovarian suppression or ablation concomitantly with oral ET medication, starting before or at the same time as oral ET initiation. Participants with chemotherapy-induced amenorrhea or ovarian failure at time of registration must be planning to start ovarian suppression or ablation if they have recurrence of ovarian function during study participation (circulating estradiol concentration in the premenopausal range or recurrence of menses)
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  • Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization NOTE: Concomitant radiotherapy at the time of randomization and/or during study participation is allowed
  • Participants who received chemotherapy must have finished it at least 14 days prior to randomization NOTE: Concomitant maintenance targeted or biologic therapy (e.g., human epidermal growth factor receptor 2 [anti-HER2] therapy, poly-ADP ribose polymerase [PARP] inhibitor therapy, CDK4/6 inhibitor therapy, osteoclast inhibitor therapy) at the time of randomization and/or during study participation is allowed
  • Participants must be >= 18 years of age
  • Participants must have a complete medical history within 60 days prior to randomization
  • Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English or Spanish
  • Participants must:
  • agree to complete PROs at all scheduled assessments and
  • complete the pre-registration (baseline) PRO forms within 14 days prior to randomization
  • Participants must be able to complete symptom questions on a web browser (on a smartphone, tablet, or computer) or respond via voice on a telephone in English or Spanish. Participants must agree to complete symptom questions at all scheduled assessments NOTE: Participants who do not have access to the internet and who cannot receive telephone calls for interactive voice response system (IVRS) assessments are not eligible
  • Participants must be offered the opportunity to participate in specimen banking for translational medicine. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Who cannot join

  • Participants must not have distant metastatic breast cancer
  • Participants who have started or plan to start treatment with tamoxifen during study participation must not have received prior tamoxifen for treatment or prevention of breast cancer
  • Participants who have started or plan to start treatment with an aromatase inhibitor during study participation must not have received prior aromatase inhibitor therapy for treatment or prevention of breast cancer
  • Participants must not be taking or planning to take oral estrogen-or progesterone-containing treatments during study participation
  • NOTES:
  • Participants who start or plan to start treatment with an aromatase inhibitor may have previously received tamoxifen for prevention of breast cancer or treatment of a prior cancer
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  • Participants may have received prior treatment with an aromatase inhibitor for infertility treatment
  • Participants must not be planning to become pregnant during the 80 weeks of study participation
  • Participants must not receive additional anti-cancer treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial
  • Participants must not have a non-breast malignancy for which they are currently receiving treatment

Trial locations and contacts

490 sites in 2 countries.

301 sites in 2 countries

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Advocate Good Shepherd Hospital

    Barrington, Illinois, 60010

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Kaiser Permanente-Burke Medical Center

    Burke, Virginia, 22015

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Marshall Cancer Center

    Cameron Park, California, 95682

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • AtlantiCare Health Park-Cape May Court House

    Cape May Court House, New Jersey, 08210

  • Mercy Cancer Center �� Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Broward Health North

    Deerfield Beach, Florida, 33064

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Epic Care-Dublin

    Dublin, California, 94568

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • STCC at DHR Health Institute for Research and Development

    Edinburg, Texas, 78539

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • AtlantiCare Surgery Center

    Egg Harbor, New Jersey, 08234

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Beebe South Coastal Health Campus

    Frankford, Delaware, 19945

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Horizon Ridge

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • GenesisCare USA - Henderson

    Henderson, Nevada, 89074

  • Las Vegas Urology - Green Valley

    Henderson, Nevada, 89074

  • Las Vegas Urology - Pebble

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Diagnostic Radiology Services LLC

    Honolulu, Hawaii, 96817

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Straub Medical Center - Kahului Clinic

    Kahului, Hawaii, 96732

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Ascension Borgess Cancer Center

    Kalamazoo, Michigan, 49009

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Kaiser Permanente - Kensington Medical Center

    Kensington, Maryland, 20895

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Marshfield Clinic - Ladysmith Center

    Ladysmith, Wisconsin, 54848

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • The Watson Clinic

    Lakeland, Florida, 33805

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Kaiser Permanente - Largo Medical Center

    Largo, Maryland, 20774

  • Las Vegas Urology - Pecos

    Las Vegas, Nevada, 89074

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Hope Cancer Care of Nevada

    Las Vegas, Nevada, 89103

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Urology Specialists of Nevada - Central

    Las Vegas, Nevada, 89106

  • GenesisCare USA - Las Vegas

    Las Vegas, Nevada, 89109

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Las Vegas Prostate Cancer Center

    Las Vegas, Nevada, 89113

  • Las Vegas Urology - Sunset

    Las Vegas, Nevada, 89113

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • GenesisCare USA - Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Cathedral Rock

    Las Vegas, Nevada, 89128

  • Las Vegas Urology - Smoke Ranch

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • GenesisCare USA - Fort Apache

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • University Cancer Center

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Saint Joseph Hospital

    Lexington, Kentucky, 40504

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Condell Memorial Hospital

    Libertyville, Illinois, 60048

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Saint Joseph London

    London, Kentucky, 40741

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Kaiser Permanente Lutherville - Timonium Medical Center

    Lutherville, Maryland, 21093

  • Centra Lynchburg Hematology-Oncology Clinic Inc

    Lynchburg, Virginia, 24501

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • Michigan Breast Specialists-Macomb Township

    Macomb, Michigan, 48044

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Summa Health Medina Medical Center

    Medina, Ohio, 44256

  • Garnet Health Medical Center

    Middletown, New York, 10940

  • Bayhealth Hospital Sussex Campus

    Milford, Delaware, 19963

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Saint Joseph Mount Sterling

    Mount Sterling, Kentucky, 40353

  • Marshfield Medical Center - Neillsville

    Neillsville, Wisconsin, 54456

Other trials in United States

Peru1 site

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

Other trials in Peru

About this study

Official title: A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN)

This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare persistence with the initially prescribed oral endocrine therapy (ET) through 72 weeks for young women being treated for hormone-receptor positive stage I-III breast cancer randomized to Active Symptom Monitoring (ASM) + patient education or patient education alone.

SECONDARY OBJECTIVES:

  1. To compare patient-reported adherence with the initially prescribed oral ET over time as assessed with the Voils measure between the two arms.

II. To compare worst pain as assessed with the Brief Pain Inventory, in aromatase inhibitors-treated (AI-treated) participants over time between the two arms.

III. To compare hot flashes as assessed with the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Endocrine Symptoms Scale in tamoxifen-treated participants over time between the two arms.

EXPLORATORY OBJECTIVES:

  1. To describe key treatment-emergent symptoms as assessed with the Brief Pain Inventory, the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile, the PROMIS Cognitive Function, and the FACT-ES Endocrine Symptoms Scale over time between the two arms.

II. To develop a composite risk prediction model (including demographics, socioeconomic variables, and clinical variables) to identify participants who are most likely to benefit from ASM.

III. To examine associations between baseline symptom bother as assessed with the GP5 item from the FACT-ES and persistence with oral ET.

IV. To examine the pattern by arm of treatment toxicity from the oral ET agents that are prescribed in this study over time during the first 24 weeks.

  1. To compare biochemically determined adherence with the initially prescribed oral ET as assessed with centrally evaluated drug concentrations and metabolites between ASM + patient education and patient education alone over time.

VI. To examine associations overall and by arm between baseline estradiol concentrations evaluated centrally and development of treatment-emergent symptoms as assessed with the Brief Pain Inventory, the PROMIS-29 Profile, the PROMIS Cognitive Function, and the FACT-ES endocrine symptoms scale.

VII. To determine patterns of change overall and by arm in centrally evaluated estradiol concentrations during study participation in participants with chemotherapy-induced ovarian failure, those receiving gonadotrophin releasing hormone (GnRH) agonist therapy, and those who had undergone bilateral salpingo-oophorectomy.

VIII: To identify inherited genetic variants using genome-wide genotyping that contribute to development of endocrine therapy-emergent toxicity.

BANKING OBJECTIVE:

  1. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients are asked 6 brief questions about symptoms weekly by email, text, or phone call for the first 6 months, then every 4 weeks for 12 months. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.

ARM II: Patients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at 3, 12, and 18 months.

Being tested
Best Practice, Biospecimen Collection, Endocrine Drug Therapy, Health Education, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Standard of care hormone therapy and standard visit with clinician

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo correlative studies

  • Endocrine Drug TherapyProcedure or surgery

    Undergo endocrine therapy

  • Health EducationBehavioural

    Receive list of websites

  • Questionnaire AdministrationOther

    Ancillary studies

  • Symptom Specific Assessment ToolOther

    Also called Symptom Assessment Tool, Symptom-Specific Assessment Tool

    Receive a weblink via email or text message and asked 6 brief questions about symptoms

Study groups in NCT05568472
Study groupRoleWhat they receive
ARM I (ET, health education, symptom assessment)ExperimentalPatients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients are asked 6 brief questions about symptoms weekly by email, text, or phone call for the first 6 months, then every 4 weeks for 12 months. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at baseline, 3, 12, and 18 months.
Receives: Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Endocrine Drug Therapy; Behavioral: Health Education; Other: Questionnaire Administration; Other: Symptom Specific Assessment Tool
ARM II (ET, health education)Active comparatorPatients receive ET and standard of care clinic visits with a cancer provider at 12, 24, 36, 48, 60, and 72 weeks, and phone visit at 80 weeks to access ongoing use ET medication. Patients also receive a list of websites with information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health. Patients have the option to submit blood specimen collection at 3, 12, and 18 months.
Receives: Other: Best Practice; Procedure: Biospecimen Collection; Procedure: Endocrine Drug Therapy; Behavioral: Health Education; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Persistence with initially prescribed oral estrogen (ET) medication

    Will be assessed by the treating provider at each study visit every 12 weeks and prospectively documented on the S2010 treatment log, including any switch from the initially prescribed oral ET. Persistence with initially prescribed oral ET by intervention arm out to 72 weeks will be described using Kaplan-Meier plots. Potential differences by arm will be tested using multivariable Cox regression. Persistence with any oral ET (aromatase inhibitor [AI] and/or tamoxifen) at 72 weeks by arm will be examined in a consistent manner. The study stratification variables (age [< 45 vs >= 45], chemotherapy [yes/no], and ET [AI vs tamoxifen]), as well as race, ethnicity, and disease stage, will be included as covariates in the regression models. In the timeframe of evaluation, censored events (newly diagnosed cancer, cancer recurrence, or death) are anticipated to be low.

    Measured: From randomization to discontinuation of the initially prescribed ET for more than 60 days or switching to a new oral ET medication, assessed up to 72 weeks

Secondary outcomes (3)

  1. Occurrence of any non-adherence

    Will be assessed using the Voils validated adherence tool that both determines the extent of nonadherence as well as reasons for non-adherence. Kaplan Meier plots will be used to describe patterns of non-adherence between arms. Multivariable Cox regression will be used to assess this secondary endpoint.

    Measured: Up to 18 months

  2. Worst pain

    Will be measured using the Brief Pain Inventory - Short Form (BPI-SF) "worst pain" question ("Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours") in the subset of patients planning to receive AI treatment. Worst pain is measured on an 11-point scale of 0 ("no pain") to 10 ("pain as bad as you can imagine"). Linear regression will be used, adjusting for the stratification factors and the baseline score.

    Measured: Up to 12 weeks

  3. Incidence of hot flashes

    Will be assessed using the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) "I have hot flashes/hot flushes" (ES1) question in the subset of patients planning to receive tamoxifen therapy. Hot flashes/hot flushes are measured on a scale of 0 ("not at all") to 4 ("very much"), with higher values indicating increased concern over the past 7 days. Linear regression will be used to compare scores between arms, adjusting for the stratification factors and the baseline score.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start29 Mar 2023
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05568472
Sponsor's protocol ID
S2010
Other IDs
NCI-2022-06902, S2010, SWOG-S2010, S2010, R01CA266012, UG1CA189974
Status last verified
Apr 2026
First submitted
23 Sep 2022
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Henry NL, Unger JM, Vaidya R, Darke AK, Skaar TC, Fisch MJ, Hershman DL. Active symptom monitoring for premenopausal women with breast cancer initiating adjuvant endocrine therapy: Protocol for the SWOG S2010 randomized controlled efficacy trial. Contemp Clin Trials. 2024 Dec;147:107712. doi: 10.1016/j.cct.2024.107712. Epub 2024 Oct 10.

    PubMed 39395534

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Biospecimen Collection and Endocrine Drug Therapy in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by SWOG Cancer Research Network at 490 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 490 sites in United States, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistence with initially prescribed oral estrogen (ET) medication (time frame: From randomization to discontinuation of the initially prescribed ET for more than 60 days or switching to a new oral ET medication, assessed up to 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05568472, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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