The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Breast Neoplasms Clinical Trial

Official title:

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02400190
• Other study ID #: UMCC 2014.111
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2015
• Est. completion date: May 2026

Study information

• Verified date: September 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 202
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• endocrine therapy alone without radiotherapy
Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Harvard University	Cambridge	Massachusetts
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	East Carolina University	Greenville	North Carolina
United States	Northwell Health	Lake Success	New York
United States	Loyola University Medical Center	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Stanford University	Stanford	California

Sponsors (12)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	East Carolina University, Harvard University, Johns Hopkins University, Loyola University, Medical College of Wisconsin, Memorial Sloan Kettering Cancer Center, Rutgers Cancer Institute of New Jersey, Stanford University, University of Pennsylvania, University of Texas Southwestern Medical Center, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Eng — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years of follow up