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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00092923 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| East Carolina University | OTHER |
| Stanford University | OTHER |
| Harvard University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocrine therapy alone | Experimental | Patients receive endocrine therapy alone without radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endocrine therapy alone without radiotherapy | Other | Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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)
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:
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| Name | Affiliation | Role |
|---|---|---|
| Reshma Jagsi, M.D., Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20065188 | Background | 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. | |
| 12393820 |
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| OTHER |
| Yale University | OTHER |
| University of Pennsylvania | OTHER |
| Medical College of Wisconsin | OTHER |
| Memorial Sloan Kettering Cancer Center | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Johns Hopkins University | OTHER |
| Loyola University | OTHER |
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| New Haven |
| Connecticut |
| 06520 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Johns Hopkins University | Baltimore | Maryland | United States |
| Harvard University | Cambridge | Massachusetts | 02138 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| East Carolina University | Greenville | North Carolina | 27853 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Result |
| 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. |
| 38060195 | Derived | Jagsi R, Griffith KA, Harris EE, Wright JL, Recht A, Taghian AG, Lee L, Moran MS, Small W Jr, Johnstone C, Rahimi A, Freedman G, Muzaffar M, Haffty B, Horst K, Powell SN, Sharp J, Sabel M, Schott A, El-Tamer M. Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA. J Clin Oncol. 2024 Feb 1;42(4):390-398. doi: 10.1200/JCO.23.02270. Epub 2023 Dec 7. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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