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Exercise may alter breast tissue markers linked to cancer risk

NCT ID NCT03657628

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looks at whether a 12-week exercise program can change certain markers in breast tissue and blood of premenopausal women with dense breasts. Dense breast tissue is a known risk factor for breast cancer. The study involves 60 physically inactive women who will do strength training and aerobic exercise. Researchers will measure changes in a cell growth marker called Ki-67 and other immune-related substances to see if exercise might help lower cancer risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
exercise intervention (strength training and aerobic exercise)
What this could lead to
If it works, this could show that regular exercise changes breast tissue in a way that may lower breast cancer risk for women with dense breasts.
What could go wrong
This is a small pilot study with only 60 women, so results may not apply to everyone. It looks at tissue markers, not actual cancer rates, so any link to cancer prevention is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent prior to any study-related procedures * Premenopausal women, defined as: * having regular menstrual cycles * age ≤ 50 years with an intact IUD * history of hysterectomy without oophorectomy * Heterogeneously dense or very dense (BIRADS 3 or 4) breast tissue on mammogram within the last 3 years * Physically inactive; engaging in \<90 minutes of moderate or vigorous intensity PA per week * No prior history of breast cancer * At least 18 years old * Physically able to exercise * English speaking and able to read English Exclusion Criteria: * Self-reported inability to walk 2 blocks (at any pace) * Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated. * On oral contraceptives; Mirena IUD is acceptable * 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. * Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.