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The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Primary Purpose

Breast Neoplasms

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endocrine therapy alone without radiotherapy
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring radiation, lumpectomy, favorable biology, omission

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endocrine therapy alone

Arm Description

Patients receive endocrine therapy alone without radiotherapy

Outcomes

Primary Outcome Measures

Loco-regional Recurrence
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2015
Last Updated
September 21, 2023
Sponsor
University of Michigan Rogel Cancer Center
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
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1. Study Identification

Unique Protocol Identification Number
NCT02400190
Brief Title
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
Official Title
The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
radiation, lumpectomy, favorable biology, omission

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocrine therapy alone
Arm Type
Experimental
Arm Description
Patients receive endocrine therapy alone without radiotherapy
Intervention Type
Other
Intervention Name(s)
endocrine therapy alone without radiotherapy
Intervention Description
Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.
Primary Outcome Measure Information:
Title
Loco-regional Recurrence
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.
Time Frame
5 years of follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reshma Jagsi, M.D., Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Harvard University
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27853
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20065188
Citation
Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP, Watson D, Geyer CE Jr, Wickerham DL, Wolmark N. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol. 2010 Apr 1;28(10):1677-83. doi: 10.1200/JCO.2009.23.7610. Epub 2010 Jan 11.
Results Reference
background
PubMed Identifier
12393820
Citation
Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
Results Reference
result

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The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

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