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The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

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ClinicalTrials.gov Identifier: NCT02400190
Recruitment Status : Active, not recruiting
First Posted : March 26, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
East Carolina University
Stanford University
Harvard University
Yale University
University of Pennsylvania
Medical College of Wisconsin
Memorial Sloan Kettering Cancer Center
University of Texas Southwestern Medical Center
Johns Hopkins University
Loyola University
Information provided by (Responsible Party):
University of Michigan Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Other: endocrine therapy alone without radiotherapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
Study Start Date : March 2015
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400190


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, Massachusetts
Harvard University
Cambridge, Massachusetts, United States, 02138
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Northwell Health
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27853
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Michigan Cancer Center
Rutgers Cancer Institute of New Jersey
East Carolina University
Stanford University
Harvard University
Yale University
University of Pennsylvania
Medical College of Wisconsin
Memorial Sloan Kettering Cancer Center
University of Texas Southwestern Medical Center
Johns Hopkins University
Loyola University
Investigators
Principal Investigator: Reshma Jagsi, M.D., Ph.D. University of Michigan
More Information
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Publications of Results:

Other Publications:

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT02400190     History of Changes
Other Study ID Numbers: UMCC 2014.111
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Keywords provided by University of Michigan Cancer Center:
radiation
lumpectomy
favorable biology
omission

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases