endocrine therapy alone without radiotherapy for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancerendocrine therapy alone without radiotherapy - Other
Eligibility
50 - 69
Female
What conditions do you have?
Select

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

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 years of follow up

Year 5
Loco-regional Recurrence

Trial Safety

Safety Progress

1 of 3

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: Other

Trial 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
70 Previous Clinical Trials
18,558 Total Patients Enrolled
8 Trials studying Breast Cancer
1,923 Patients Enrolled for Breast Cancer
Yale UniversityOTHER
1,679 Previous Clinical Trials
21,087,837 Total Patients Enrolled
25 Trials studying Breast Cancer
3,147 Patients Enrolled for Breast Cancer
Medical College of WisconsinOTHER
566 Previous Clinical Trials
1,153,958 Total Patients Enrolled
10 Trials studying Breast Cancer
407,073 Patients Enrolled for Breast Cancer
Stanford UniversityOTHER
2,170 Previous Clinical Trials
35,768,081 Total Patients Enrolled
57 Trials studying Breast Cancer
111,173 Patients Enrolled for Breast Cancer
Harvard UniversityOTHER
213 Previous Clinical Trials
18,228,321 Total Patients Enrolled
East Carolina UniversityOTHER
95 Previous Clinical Trials
35,118 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
University of Michigan Rogel Cancer CenterLead Sponsor
268 Previous Clinical Trials
17,926 Total Patients Enrolled
29 Trials studying Breast Cancer
3,849 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterOTHER
953 Previous Clinical Trials
608,632 Total Patients Enrolled
21 Trials studying Breast Cancer
6,286 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,076 Previous Clinical Trials
31,019,991 Total Patients Enrolled
25 Trials studying Breast Cancer
23,194 Patients Enrolled for Breast Cancer
Loyola UniversityOTHER
146 Previous Clinical Trials
29,848 Total Patients Enrolled
3 Trials studying Breast Cancer
246 Patients Enrolled for Breast Cancer
University of PennsylvaniaOTHER
1,841 Previous Clinical Trials
41,126,214 Total Patients Enrolled
27 Trials studying Breast Cancer
24,740 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterOTHER
1,832 Previous Clinical Trials
584,336 Total Patients Enrolled
193 Trials studying Breast Cancer
93,769 Patients Enrolled for Breast Cancer
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