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The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

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ClinicalTrials.gov Identifier: NCT02400190
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : October 26, 2017
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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

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.




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.



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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.

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


Contacts
Contact: Reshma L Jagsi, M.D., Ph.D. 734-936-4300 rjagsi@med.umich.edu
Contact: Jody L Sharp, B.S. 734-615-4909 sharpjd@med.umich.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Kate Horst, M.D.       kateh@stanford.edu   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Meena Moran, M.D.       meena.moran@yale.edu   
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Tarita Thomas, MD       tathomas@lumc.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States
Contact: Jean Wright, MD       jeanwright@jhmi.edu   
United States, Massachusetts
Harvard University Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Abe Recht, M.D.       arecht@bidmc.harvard.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Reshma Jagsi, M.D., Ph.D.    734-936-4300    rjagsi@med.umich.edu   
Contact: Jody L Sharp, B.S.    734-615-4909    sharpjd@med.umich.edu   
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Bruce Haffty, M.D.       hafftybg@cinj.rutgers.edu   
United States, New York
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Lucille N Lee, M.D.    516-321-3035    LLee3@northwell.edu   
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mahmoud El-Tamer, M.D.       ElTamerM@mskcc.org   
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27853
Contact: Eleanor Harris, M.D.       harrisel@ecu.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gary Freedman, M.D.       Gary.Freedman@uphs.upenn.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Asal Rahimi, M.D.       Asal.Rahimi@UTSouthwestern.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Candice Johnstone, M.D.       cjohnstone@mcw.edu   
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