The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

• ClinicalTrials.gov Identifier: NCT02400190
• Recruitment Status: Active, not recruiting
• First Posted: March 26, 2015
• Last Update Posted: October 9, 2019
• 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
• Information provided by (Responsible Party): University of Michigan Rogel Cancer Center

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.

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 202 participants
• Allocation: N/A
• 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

Arms and Interventions

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

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

• 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

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 Rogel 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

Publications of Results:

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.

Other Publications:

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.

• Responsible Party: University of Michigan Rogel Cancer Center
• ClinicalTrials.gov Identifier: NCT02400190
• Other Study ID Numbers: UMCC 2014.111
• First Posted: March 26, 2015
• Last Update Posted: October 9, 2019
• Last Verified: October 2019

Keywords provided by University of Michigan Rogel Cancer Center:

radiation; lumpectomy; favorable biology; omission

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases