Body composition and outcomes after breast reconstruction

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 observational study enrolls adults undergoing mastectomy with immediate reconstruction and collects body composition measurements alongside chart review, with participants followed for up to two years. Participants are assigned to one of two cohorts and undergo standardized body composition testing and routine clinical follow-up. The primary aim is to determine the feasibility of collecting these measurements; secondary aims compare body composition between those who develop reconstruction complications and those who do not and compare composition measures to standard anthropometric assessments. Analyses will look for associations between specific composition metrics and postoperative outcomes to inform risk stratification.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy.
2. Age ≥ 18 years.
3. Scheduled to undergo mastectomy with immediate breast reconstruction using a permanent implant, tissue expander, or autologous tissue (e.g. Deep Inferior Epigastric Perforator (DIEP) flap, muscle-sparing Transverse Rectus Abdominis Myocutaneous (msTRAM) flap, Profunda Artery Perforator (PAP) flap).
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
2. Pregnant or breastfeeding.
3. Patients assigned male at birth.
4. Non-cisgender women.
5. Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator).
6. Patients with prosthetic limbs.

Where it's running

• University of California
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Merisas Piper, MD — University of California, San Francisco
• Study coordinator: Michael Choi
• Email: Michael.Choi@ucsf.edu
• Phone: 877-827-3222

Similar studies

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

• CSF sample collection from people with metastatic breast cancer to see brain metastasis risk

  This study tests whether spinal fluid and other samples can help predict brain metastases in adults with metastatic HER2-positive or triple-negative breast cancer who have not yet shown brain involvement.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07619534

• Support tool for women with HR+ breast cancer on long-term endocrine therapy

  This study tests a SHIELD web- and app-based portal to help women with hormone receptor–positive breast cancer manage symptoms while on long-term endocrine treatment.

  Recruiting Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07482384

• ENLIGHT algorithm to find treatment options for advanced metastatic breast cancer

  This test uses the ENLIGHT algorithm to try to find approved drugs that might work better for adults with triple-negative or endocrine therapy–resistant metastatic breast cancer.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07067138

• Radiology-based prediction of HER2 level and T‑DXd benefit in metastatic breast cancer

  This study tests whether patterns in CT or FDG‑PET images can show HER2 level and help predict response to trastuzumab deruxtecan for people with metastatic breast cancer.

  Recruiting Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Milan · NCT07030569

• Omitting full axillary dissection when breast cancer has spread to armpit nodes

  The trial tests whether removing only the sentinel and known cancerous lymph nodes is as safe as removing many more armpit nodes in people with breast cancer and armpit node involvement.

  Recruiting at 4 sites Karolinska Institutet · Helsinki and 3 other locations · NCT06869629

• Predicting outcomes for advanced breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy

  This study is trying to see how well different CDK4/6 inhibitors combined with hormone therapy work for people with advanced breast cancer and how safe they are.

  Recruiting at 24 sites Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Aviano and 23 other locations · NCT06805812

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.