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ACTIVE NOT RECRUITING

NCT05568472

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

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

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. 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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

565

Start Date

2023-03-29

Completion Date

2028-05-01

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Hormone Receptor-Positive Breast Carcinoma

Interventions

OTHER

Best Practice

Standard of care hormone therapy and standard visit with clinician

PROCEDURE

Biospecimen Collection

Undergo correlative studies

PROCEDURE

Endocrine Drug Therapy

Undergo endocrine therapy

BEHAVIORAL

Health Education

Receive list of websites

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Symptom Specific Assessment Tool

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

Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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

Locations (490)

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Marshall Cancer Center

Cameron Park, California, United States

Mercy Cancer Center �� Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Epic Care-Dublin

Dublin, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Saint John's Cancer Institute

Santa Monica, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Southwest Oncology PC

Durango, Colorado, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Parker Adventist Hospital

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Bayhealth Hospital Sussex Campus

Milford, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Kaiser Permanente-Capitol Hill Medical Center

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

Broward Health North

Deerfield Beach, Florida, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

The Watson Clinic

Lakeland, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

South Florida Baptist Hospital

Plant City, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Northside Hospital - Duluth

Duluth, Georgia, United States

Eisenhower Army Medical Center

Fort Gordon, Georgia, United States

Northside Hospital - Gwinnett

Lawrenceville, Georgia, United States

South Georgia Medical Center/Pearlman Cancer Center

Valdosta, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza