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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 have completed surgery for treatment of breast cancer at least 14 days prior to randomization
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 had breast cancer surgery at least 14 days ago.
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I have started or will start hormone therapy for my cancer within 14 days of joining the study.
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I will start or am willing to undergo ovarian suppression if I still have ovarian function.
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I finished chemotherapy more than 14 days ago.
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I agree to fill out health questionnaires as scheduled and before starting the trial.
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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 can complete health surveys in English or Spanish.
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I am a woman with Stage I, II, or III breast cancer that is hormone receptor positive.
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I have a full medical history from the last 2 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estrogens
Secondary outcome measures
Hot flushes
Occurrence of any non-adherence
Pain
Other outcome measures
Pharmaceutical Preparations
Estradiol concentration
Genotyping
+6 more

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
~4000
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,807 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,271 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,630 Total Patients Enrolled
54 Trials studying Breast Cancer
65,326 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Hormone Therapy Highlights & Side Effects. Trial Name: NCT05568472 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this research study?

"Affirmative. Per the records on clinicaltrials.gov, this trial is in-progress and actively seeking participants; it was posted on January 17th 2023 and last modified one week later. 540 patients are needed to conduct the study at a single location."

Answered by AI

What is the sample size of participants in this clinical trial?

"That is accurate. According to clinicaltrials.gov, this medical experiment was initially posted on January 17th 2023 and has been actively recruiting participants since then. The study requires approximately 540 patients to be drawn from one site."

Answered by AI
~360 spots leftby May 2027