Factors Associated With Breast Cancer Risks and Outcomes

April 16, 2026 updated by: Memorial Sloan Kettering Cancer Center

Genomic and Non-Genomic Factors Associated With Breast Cancer Risk Factors and Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited protocol activities)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activites)
        • Contact:
          • Neha Goel, MD, MPH
          • Phone Number: 646-888-4298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Women 18 years and older who are patients with a suspicious breast finding who present to breast radiology at MSK for biopsy or any new breast cancer patient seen at MSK undergoing surgery.

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Survey

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival/RFS
Time Frame: 5 years
RFS as defined by the STEEP 2.0 guidelines
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Neha Goel, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Estimated)

December 8, 2031

Study Completion (Estimated)

December 8, 2031

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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