Your session is about to expire
← Back to Search
Hormone Therapy
Symptom Monitoring for Young Women on Hormone Therapy for Breast Cancer
N/A
Recruiting
Led By Norah L Henry
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be able to complete symptom questions on a web browser or respond via voice on a telephone in English or Spanish. Participants must agree to complete symptom questions at all scheduled assessments
Participants must be >= 18 years of age
Must not have
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 must not have a non-breast malignancy for which they are currently receiving treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will determine if asking about symptoms more often helps young women stay on hormone therapy for breast cancer, reducing side effects and increasing their chances of a successful treatment.
Who is the study for?
This trial is for young women aged 18 or older with Stage I-III hormone receptor positive breast cancer. They must have completed chemotherapy, surgery, and started or plan to start standard oral endocrine therapy. Participants need to be pre- or peri-menopausal at diagnosis and able to complete surveys in English or Spanish. Exclusions include current treatment for non-breast malignancies, prior aromatase inhibitor therapy, metastatic cancer, use of estrogen/progesterone treatments during the study, pregnancy plans within 80 weeks of study participation.
What is being tested?
The ASPEN Study is testing whether active symptom monitoring plus patient education helps young women continue their hormone therapy compared to patient education alone. The intervention includes a web-based symptom assessment tool and educational material about managing side effects from hormone therapy medicines.
What are the potential side effects?
Hormone therapies like tamoxifen and aromatase inhibitors can cause hot flashes, mood swings, fatigue, joint pain, bone thinning (osteoporosis), changes in menstrual cycle for premenopausal women and increased risk of blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can answer health questions in English or Spanish online or by phone.
Select...
I am 18 years old or older.
Select...
I am a woman with Stage I, II, or III breast cancer that is hormone receptor positive.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never taken tamoxifen for breast cancer before.
Select...
I am not currently being treated for cancer outside of my breast.
Select...
I have not previously taken aromatase inhibitors for breast cancer.
Select...
My breast cancer has not spread to distant parts of my body.
Select...
I am not taking and do not plan to take any estrogen or progesterone treatments.
Select...
I am not participating in another clinical trial for cancer treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Estrogens
Secondary study objectives
Hot flushes
Occurrence of any non-adherence
Pain
Other study objectives
Pharmaceutical Preparations
Estradiol concentration
Genotyping
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ARM I (ET, health education, symptom assessment)Experimental Treatment6 Interventions
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.
Group II: ARM II (ET, health education)Active Control5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Education
2014
Completed Phase 3
~4410
Biospecimen Collection
2004
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,879 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,661 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,076 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
Norah L HenryPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.