WithdrawnNot Applicable

Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Stopped: insufficient staff

United States0Started 2019-05-31

Plain-language summary

The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Who can participate

Age range

19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy. * Subjects must be breast reconstruction candidates using implant based breast reconstruction. * Subjects must have a pre-operative risk \>20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior breast cancer surgical treatment * Prior breast reconstruction * Inability to provide written consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications

Timeframe: Until 1 year post breast reconstruction

Trial details

NCT IDNCT03261323

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07

View on ClinicalTrials.gov More Breast Cancer trials