Clinical Trials /

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

NCT02400190

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
  • Official Title: The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2014.111
  • NCT ID: NCT02400190

Conditions

  • Breast Neoplasms

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Endocrine therapy aloneExperimentalPatients receive endocrine therapy alone without radiotherapy

    Eligibility 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.
          
    Maximum Eligible Age:69 Years
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Loco-regional Recurrence
    Time Frame:5 years of follow up
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Michigan Cancer Center

    Trial Keywords

    • radiation
    • lumpectomy
    • favorable biology
    • omission

    Last Updated

    October 24, 2017