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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 below
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I can answer health questions in English or Spanish online or by phone.
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I am 18 years old or older.
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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:
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I have never taken tamoxifen for breast cancer before.
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I am not currently being treated for cancer outside of my breast.
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I have not previously taken aromatase inhibitors for breast cancer.
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My breast cancer has not spread to distant parts of my body.
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I am not taking and do not plan to take any estrogen or progesterone treatments.
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I am not participating in another clinical trial for cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

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 more

Awards & 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
~2020

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,899 Previous Clinical Trials
41,013,563 Total Patients Enrolled
346 Trials studying Breast Cancer
869,313 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,647 Total Patients Enrolled
17 Trials studying Breast Cancer
17,226 Patients Enrolled for Breast Cancer
SWOG Cancer Research NetworkLead Sponsor
397 Previous Clinical Trials
265,742 Total Patients Enrolled
17 Trials studying Breast Cancer
17,226 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Hormone Therapy Highlights & Side Effects. Trial Name: NCT05568472 — N/A
~331 spots leftby May 2027
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