The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

September 21, 2023 updated by: University of Michigan Rogel Cancer Center
This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study's primary aim is to determine rates of recurrence with the innovative approach of considering tumor biology to select patients who may avoid radiation, with restriction of eligibility to women aged 50-69 with hormone-sensitive, Her2-negative tumors with Oncotype-DX RS ≤ 18 who plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at low risk of LRR in whom omission of adjuvant radiation is reasonable.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins University
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Harvard University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Greenville, North Carolina, United States, 27853
        • East Carolina University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

48 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal status, as defined by (a) patients age 60 or greater, or, (b) patients age 50-69 with either (a) s/p bilateral oophorectomy, or, (b) intact uterus without menses in the past 12 months, or, (c) biochemical confirmation of postmenopausal status.
  • Histopathological confirmation of Stage 1 (pT1N0M0) invasive breast cancer status post breast conserving surgery

  • Negative axillary nodes (isolated tumor cells with no cluster measuring >0.2mm allowed)

    • Allowable options for axillary staging include:
    • Sentinel node biopsy only
    • Sentinel node biopsy followed by axillary dissection
    • Axillary dissection only
  • Margins of excision ≥2mm
  • ER+, PR+, Her2 - using the current College of American Pathologists guidelines
  • Oncotype-DX RS ≤ 18
  • Disease must be unifocal on clinical, radiologic, and pathologic examination
  • Registration within 90 days of last surgical procedure for breast cancer treatment
  • Patient must willingly sign study specific informed consent prior to study entry
  • Patient must be a candidate for and willing to take endocrine therapy for minimum of 5 years (aromatase inhibitor or tamoxifen). Patients who have already begun endocrine therapy after lumpectomy are eligible.
  • Patient must have had breast imaging (mammogram or MRI) of the ipsilateral breast within 6 months and contralateral breast within 1 year of study entry.
  • Patient must have Zubrod performance status 0-2

Exclusion Criteria:

  • Evidence of multifocal or multicentric breast cancer that has not been biopsy-proven negative. Note that MRI is not required for this study, but if performed, evidence of disease beyond the site of the primary tumor in the ipsilateral breast or in the contralateral breast must be biopsy-proven not to be malignant before registration.
  • Metastatic disease. Note that no specific staging studies are mandated, but any studies performed must not provide clear evidence of metastatic spread.
  • Previous radiation therapy to the breast region
  • Prior DCIS or invasive breast cancer
  • Bilateral breast cancer
  • Prior non-breast invasive malignancy other than non-melanoma skin cancer, unless there has been no evidence of disease for at least 5 years
  • Known carrier of a mutation known to predispose towards breast cancer development (including BRCA-1 and BRCA-2). Note: testing for mutation status is not required for this protocol; this criterion applies only to patients who have been tested and have known carrier status.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endocrine therapy alone
Patients receive endocrine therapy alone without radiotherapy
Other: endocrine therapy alone without radiotherapy
Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loco-regional Recurrence
Time Frame: 5 years of follow up
All patients will be followed for their clinical outcome for at least 10 years, specifically: for development of recurrence (and site), the salvage therapy type if local disease recurs, for development of distant metastasis, and survival - both overall and breast-cancer specific.
5 years of follow up

Collaborators and Investigators

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

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Johns Hopkins University
Memorial Sloan Kettering Cancer Center
University of Pennsylvania
Yale University
Medical College of Wisconsin
Stanford University
University of Texas Southwestern Medical Center
Harvard University
East Carolina University
Rutgers Cancer Institute of New Jersey
Loyola University

Investigators

  • Principal Investigator: Reshma Jagsi, M.D., Ph.D., University of Michigan

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.

General Publications

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)

May 27, 2015

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimated)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2014.111

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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