The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

Not Applicable

Active, not recruiting

• Conditions: Breast Neoplasms
• Interventions: Other: endocrine therapy alone without radiotherapy

• Registration Number: NCT02400190
• Lead Sponsor: University of Michigan Rogel 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.

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 Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Study Start: 2015-05-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endocrine therapy alone	endocrine therapy alone without radiotherapy	Patients receive endocrine therapy alone without radiotherapy

Primary Outcome Measures

Name	Time	Method
Loco-regional Recurrence	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.

Trial Locations

Locations (13)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Harvard University; 🇺🇸 Cambridge, Massachusetts, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Stanford University; 🇺🇸 Stanford, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States