What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as endocrine therapy (tamoxifen and aromatase inhibitors), chemotherapy, and targeted therapies, have various side effects. Endocrine therapy can cause hair thinning, bone density loss, fractures, and cardiovascular risks. Chemotherapy often leads to alopecia, fatigue, neuropathy, and increased risk of infections. Targeted therapies, including small molecule inhibitors and monoclonal antibodies, may result in partial alopecia, hair curling, and skin dyspigmentation. These side effects can significantly impact the quality of life and adherence to treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, particularly focusing on HER2-positive and hormone receptor-positive subtypes. Trastuzumab, a monoclonal antibody targeting HER2, has been a cornerstone in treating HER2-positive breast cancer, with several biosimilars now available to enhance patient access. For hormone receptor-positive breast cancer, aromatase inhibitors such as letrozole and anastrozole are commonly used, although their efficacy can be limited. These treatments are part of a broader strategy to target specific biological markers in breast cancer, similar to the ongoing studies on the impact of exercise on these markers.

What other types of research exist?

Promising novel alternatives to exercise for breast cancer patients include: 1) Dietary modifications such as low-fat diets and increased intake of fruits and vegetables, which have shown potential in reducing cancer recurrence and improving survival. 2) Weight management programs, particularly those focusing on sustained weight loss, which have been linked to lower breast cancer risk. 3) Pharmacological interventions targeting specific biological pathways, such as hormone therapy and targeted therapies like trastuzumab deruxtecan for HER2-positive breast cancer. 4) Integrative therapies including cognitive behavioral therapy and stress management techniques, which may improve overall quality of life and potentially influence biological markers.

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Exercise Intervention for Dense Breast Tissue

N/A

Waitlist Available

Led By Jennifer Ligibel, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premenopausal women with regular menstrual cycles

Premenopausal women with a history of hysterectomy without oophorectomy

Must not have

Self-reported inability to walk 2 blocks (at any pace)

Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how regular exercise affects breast tissue and blood markers in premenopausal women with dense breast tissue. These women are at higher risk for breast cancer, and exercise might help by slowing cancer cell growth and strengthening the immune system. The study aims to understand these potential benefits better.

Who is the study for?

This trial is for premenopausal women under 50 with dense breast tissue who don't exercise much (less than 90 minutes of moderate activity per week). They must be able to read English, have no history of breast cancer, and can walk at least two blocks. Women on oral contraceptives or with certain diseases that limit exercise are not eligible.

What is being tested?

The study looks at how regular exercise affects markers in the blood and breast tissue related to health. Participants will engage in an exercise intervention designed to see if physical activity can influence factors associated with breast cancer risk.

What are the potential side effects?

Since this trial involves an exercise program, potential side effects may include typical risks associated with physical activity such as muscle soreness, fatigue, or injury. However, these are generally mild and manageable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a premenopausal woman with regular periods.

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I am a premenopausal woman who has had a hysterectomy but still have my ovaries.

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I have never had breast cancer before.

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I am a woman under 50, premenopausal, and have an intact IUD.

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I can speak and read English.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk 2 blocks without assistance.

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I do not have heart, lung, or joint problems that stop me from doing moderate exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Impact of exercise upon expression of Ki-67

Secondary study objectives

Changes in minutes of weekly physical activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Physical activityExperimental Treatment1 Intervention

* The exercise intervention will consist of a supervised, moderate-intensity aerobic exercise program. * Will receive social/behavioral support * Will receive research staff contact time to encourage them to increase their physical activity level * The participants will be given the option of a third supervised session each week

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormone therapy, chemotherapy, and targeted therapy. Hormone therapy works by blocking hormones like estrogen that can promote the growth of hormone receptor-positive breast cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapy, such as HER2 inhibitors, specifically targets and inhibits the function of proteins that support cancer cell growth. These treatments are crucial for breast cancer patients as they can significantly reduce the risk of recurrence, manage symptoms, and improve survival rates. Understanding these mechanisms helps patients and healthcare providers make informed decisions about personalized treatment plans.