Group-based Comprehensive Lifestyle Program for Women With 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 interventional study tests the feasibility of delivering three versions of an evidence-based lifestyle program (ACLP, ACLP-LC, ACLP-LC-IHC) to women with stable HR+/HER2- metastatic breast cancer. Participants are randomized to one of three groups and complete 8 weeks of online modules, with weekly support calls or online group sessions. Feasibility is defined by at least 30% enrollment of eligible approached patients and at least 50% retention through the final follow-up with 75% of online sessions completed. Secondary aims include shifts in diet, exercise, stress management behaviors and changes in patient-reported outcomes such as quality of life, fatigue, sleep, mental health, social support, mindfulness, and stages of change, plus exploratory laboratory biomarkers (albumin, vitamin D, magnesium). The study is conducted at MD Anderson with potential collaboration from other sites as applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with HR+/HER2 negative MBC
2. On first- or second-line treatment
3. Life expectancy at least 12 months
4. Only females
5. Age 18 years or older
6. Able to read, write, and speak English
7. Willingness to follow protocol requirements
8. Have a smartphone with access to cellular service or computer access with internet service
9. Oriented to person, place, and time
10. Consume less than 3 servings of fruit and vegetable/day
11. Engage in less than 150 minutes moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling)
12. Engage in a mind-body practice less than 4 times a month

Exclusion Criteria:

1. Another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers)
2. Any major thought disorder (e.g., schizophrenia, dementia)
3. Communication barriers (e.g., hard of hearing)
4. Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)
5. Extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

Where it's running

• The University of Texas M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Meroe Morse, MD — M.D. Anderson Cancer Center
• Study coordinator: Meroe Morse, MD
• Email: mbmorse@mdanderson.org
• Phone: 713-794-4053

Similar studies

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

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Personalized treatment after endocrine therapy failure in metastatic breast cancer

  The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07895160

• SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer

  This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Guangzhou, Guangdong · NCT07757230

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer

  This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.

  Recruiting at 5 sites Phase 3 Daiichi Sankyo · Columbia, Maryland and 4 other locations · NCT07683754

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.