Clinical Trial Summary (S2010)
Monitoring Symptoms to Help Women Keep Taking Hormone Therapy for Early-Stage Breast Cancer
What is the purpose of this clinical trial?
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Side effects are a common reason women stop taking hormone therapy for breast cancer early. To improve how doctors help women with side effects, this study tests a new way of monitoring symptoms during treatment. |
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Generally, doctors ask patients about their symptoms at clinic visits every few months. This study tests asking women about their symptoms more often. Researchers want to find out if monitoring symptoms in between clinic visits can improve side effects from hormone therapy for women.
This trial is set up to find out:
- If women are more likely to keep taking hormone therapy when their doctors monitor symptoms in between clinic visits
- If women’s side effects improve when their doctors monitor symptoms frequently in between clinic visits
Why is this trial important?
Stopping hormone therapy early increases the chance of breast cancer coming back. Many side effects are treatable, so doctors hope improving how they monitor symptoms will help more women stay on treatment. This trial is a chance to see if more communication between doctors and patients helps them better manage side effects.
Who can be in this trial?
This trial is for women, age 18 and older, with stage 1, 2, or 3 breast cancer.
This trial may be for people who:
- Have breast cancer that is hormone receptor- positive
- Started or will start oral hormone therapy for breast cancer
- Can complete surveys in English or Spanish
This trial is not for people who:
- Have cancer that has spread to other places in the body outside of the breast
- Were diagnosed with breast cancer after menopause
- Are planning to be pregnant during the study
What can I expect during the trial?
You receive cancer treatment as usual. You and your doctor choose your hormone therapy.
To determine how your doctor will monitor your symptoms, a computer will randomly assign you to 1 of 2 study groups.
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Group 1:
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Group 2:
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Your doctor will not have control over which group you will be assigned to. This helps make sure the study results are fair and reliable.
If your symptoms get worse at any time, always tell your doctor right away.
How long will I be in the trial?
You will be in the study for about 1 year and 8 months. You may choose to stop and leave the study at any time for any reason.
Are there costs? Will I get paid?
You will not be paid for being in the study. Using your smartphone or tablet for the study surveys may add costs to your data plan.
Check with your health care provider and insurance provider to find out what costs will and won’t be covered in this study.
Where can I find more information about this trial?
Talk with your health care provider
Call the National Cancer Institute at 1-800-4-CANCER
Go to www.ClinicalTrials.gov and search using the national clinical trial number: 05568472
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S2010
NCT Number
05568472
Full Trial 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)
Trial Sponsors
SWOG Cancer Research Network
Publication Date