Exercise program for patients with indolent metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a 16-week virtual exercise program on patients with indolent metastatic breast cancer who have not experienced disease progression in the past year. Participants will be randomly assigned to either the exercise intervention or usual care, with the aim of improving cardiorespiratory fitness, physical function, and patient-reported outcomes. The exercise regimen includes both aerobic and resistance training, tailored to the participants' capabilities. The study will enroll up to 100 participants and assess various health metrics throughout the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of metastatic breast cancer
3. No progression of disease in the 12 months prior to screening per the treating investigator

   1. If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
   2. Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
4. ECOG performance status of 0-2
5. Ability to walk on a treadmill without assistive device.
6. Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
7. Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the IPAQ questionnaire administered during screening)
8. Participants should have a cellular device compatible with iOS 15 or Android operating system 7.

Exclusion Criteria:

1. Receiving cytotoxic chemotherapy at any point in the prior 12 months.

   1. Participants receiving endocrine therapy are eligible.
   2. Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
2. Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supersede this eligibility criteria.

   * NYHA class III or IV congestive heart failure
   * Uncontrolled angina
   * Myocardial infarction in the prior 12 months
   * Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
   * Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms \> 2 days/week) or dyspnea requiring oxygen
   * Symptomatic peripheral vascular disease
   * Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness
   * History of fragility fracture
3. Active, untreated brain metastases

Where it's running

• Indiana University Melvin & Bren Simon Cancer Center
  Indianapolis, Indiana, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Completed
• IU Health West
  Avon, Indiana, United States Withdrawn
• IU Health Joe and Shelly Schwarz Cancer Center
  Carmel, Indiana, United States Withdrawn
• Sidney and Lois Eskenazi Hospital
  Indianapolis, Indiana, United States Withdrawn

Study contacts

• Principal investigator: Tarah Ballinger, MD — Indiana University
• Study coordinator: Niraj Shah
• Email: shahnir@iu.edu
• Phone: (317) 278-3420

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.