Study Summary
This trial will study whether it's safe to forgo radiation treatment after lumpectomy surgery for postmenopausal women with hormone-positive, Her2-negative tumors who have a low risk of cancer recurrence.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 5 years of follow up
Year 5
Loco-regional Recurrence
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Endocrine therapy alone
1 of 1
Experimental Treatment
202 Total Participants · 1 Treatment Group
Primary Treatment: endocrine therapy alone without radiotherapy · No Placebo Group · N/A
Endocrine therapy alone
Other
Experimental Group · 1 Intervention: endocrine therapy alone without radiotherapy · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years of follow up
Who is running the clinical trial?
Rutgers Cancer Institute of New JerseyOTHER
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Yale UniversityOTHER
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Harvard UniversityOTHER
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East Carolina UniversityOTHER
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University of Michigan Rogel Cancer CenterLead Sponsor
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University of Texas Southwestern Medical CenterOTHER
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Johns Hopkins UniversityOTHER
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Loyola UniversityOTHER
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University of PennsylvaniaOTHER
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Memorial Sloan Kettering Cancer CenterOTHER
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Reshma Jagsi, M.D., Ph.D.Principal InvestigatorUniversity of Michigan
Eligibility Criteria
Age 50 - 69 · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The patient had a breast conserving surgery and it was confirmed that they have Stage 1 (pT1N0M0) invasive breast cancer.
if nodes >1.5 cm
A doctor will only do an axillary dissection if the nodes are larger than 1.5 cm.
, this combination would be considered for a chemotherapy regimen
A patient who tests positive for estrogen receptor (ER+) and progesterone receptor (PR+) and negative for human epidermal growth factor receptor 2 (Her2) would be considered for a chemotherapy regimen using the current College of American Pathologists guidelines.
The definition of postmenopausal status is based on a patient's age
helps a small number of women
Sentinel node biopsy helps a small number of women.
is the current standard of care for patients with stage I or II breast cancer
The current standard of care for patients with stage I or II breast cancer is to perform a sentinel node biopsy followed by axillary dissection.
A margin of excision ≥2mm is required for a diagnosis of cancer.
No tumor cells are found in the axillary lymph nodes.
You have an Oncotype-DX Risk Score of ≤ 18.
In order to be diagnosed with a disease, it must be unifocal on clinical, radiologic, and pathologic examination
References
- Mamounas, Eleftherios P., Gong Tang, Bernard Fisher, Soonmyung Paik, Steven Shak, Joseph P. Costantino, Drew Watson, Charles E. Geyer Jr, D. Lawrence Wickerham, and Norman Wolmark. 2010. “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”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2009.23.7610.
- Fisher, Bernard, Stewart Anderson, John Bryant, Richard G. Margolese, Melvin Deutsch, Edwin R. Fisher, Jong-Hyeon Jeong, and Norman Wolmark. 2002. “Twenty-year Follow-up of a Randomized Trial Comparing Total Mastectomy, Lumpectomy, and Lumpectomy Plus Irradiation for the Treatment of Invasive Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa022152.
- 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.
- 2015. "The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02400190.
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