Factors Associated With Breast Cancer Risks and Outcomes
Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes
1 other identifier
observational
750
1 country
7
Brief Summary
The purpose of this study is to learn more about risks and outcomes of breast cancer in people with different backgrounds. Tissue and blood will be collected from participants for research purposes. Participants will complete questionnaires during their standard medical care. The study will not provide treatment for cancer or any other condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedStudy Start
First participant enrolled
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 8, 2031
April 17, 2026
April 1, 2026
6 years
December 8, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence Free Survival/RFS
RFS as defined by the STEEP 2.0 guidelines
5 years
Study Arms (1)
Participants with a suspicious breast finding or new breast cancer diagnosis
Participants with a suspicious breast finding who present to breast radiology at MSK for biopsy or a participants with a new breast cancer diagnosis who is a surgical candidate seen at MSK.
Interventions
Complete surveys: * Baseline (within 6 months of enrollment) * 1st follow-up survey (approx. 6 months to 12 months) * 2nd follow-up survey and/or blood collection (approx. 3 years +/- 6 months) * 3rd follow-up survey and/or blood collection (approx. 5 years +/- 6 months)
Eligibility Criteria
MSK research staff and/or treating clinicians will identify participants (anyone meeting inclusion criteria listed above) prior to or during their regularly scheduled visits (Breast radiology at time of initial biopsy, Surgery clinic visit, Medical Oncology clinic visit). A member of the MSK study team will approach the participants either in person or remotely to explain details of the study and answer any questions.
You may qualify if:
- A patient cannot be considered eligible for this study unless the following conditions are met.
- Patients with a suspicious breast finding who present to breast radiology at MSK for biopsy or any new breast cancer patient who is a surgical candidate seen at MSK.
- Women 18 years of age and older are eligible to participate in the study.
You may not qualify if:
- Patients presenting with a suspicious breast mass or breast cancer less than 1 cm.
- Patients presenting to clinic with only microinvasion
- Patients who are less than 18 years of age
- Patients unable to complete the survey, including IDMC patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha Goel, MD, MPH
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
December 19, 2025
Study Start
December 8, 2025
Primary Completion (Estimated)
December 8, 2031
Study Completion (Estimated)
December 8, 2031
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.