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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

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

~2030