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Hormone Therapy

Endocrine Therapy Without Radiotherapy for Breast Cancer

N/A
Waitlist Available
Led By Reshma Jagsi, M.D., Ph.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathological confirmation of Stage 1 (pT1N0M0) invasive breast cancer status post breast conserving surgery
Patient must have Zubrod performance status 0-2
Must not have
Previous radiation therapy to the breast region
Prior DCIS or invasive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of follow up
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
Postmenopausal women with hormone receptor-positive, Her2-negative stage 1 breast cancer who've had a lumpectomy can join this study. They must have an Oncotype-DX score ≤18 and agree to take endocrine therapy for at least 5 years. Women with prior breast cancer, known genetic predispositions like BRCA mutations, or evidence of more widespread disease are excluded.
What is being tested?
The IDEA Study is exploring if certain low-risk postmenopausal women with early-stage breast cancer can skip radiotherapy after surgery and only receive endocrine therapy. It aims to understand the recurrence rates without radiation in patients meeting specific criteria.
What are the potential side effects?
While not explicitly listed here, common side effects of endocrine therapies may include hot flashes, fatigue, joint pain, mood swings, decreased sex drive and osteoporosis among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is at an early stage and was confirmed after a surgery to remove it.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am postmenopausal, either by age, surgery, or lack of menstruation.
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My Oncotype-DX score is 18 or lower.
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I've had breast imaging on both breasts within the required time before joining the study.
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My breast cancer is ER and PR positive but HER2 negative.
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My disease is located in only one area, as confirmed by exams and scans.
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My cancer surgery removed the tumor with clear margins of at least 2mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my breast before.
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I have had breast cancer or DCIS before.
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I have cancer in both of my breasts.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Loco-regional Recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Endocrine therapy aloneExperimental Treatment1 Intervention
Patients receive endocrine therapy alone without radiotherapy

Find a Location

Who is running the clinical trial?

Harvard UniversityOTHER
233 Previous Clinical Trials
473,729 Total Patients Enrolled
Yale UniversityOTHER
1,930 Previous Clinical Trials
3,033,256 Total Patients Enrolled
26 Trials studying Breast Cancer
3,027 Patients Enrolled for Breast Cancer
Rutgers Cancer Institute of New JerseyOTHER
70 Previous Clinical Trials
18,555 Total Patients Enrolled
8 Trials studying Breast Cancer
1,923 Patients Enrolled for Breast Cancer
East Carolina UniversityOTHER
109 Previous Clinical Trials
38,981 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,471 Total Patients Enrolled
29 Trials studying Breast Cancer
23,551 Patients Enrolled for Breast Cancer
Medical College of WisconsinOTHER
635 Previous Clinical Trials
1,181,500 Total Patients Enrolled
15 Trials studying Breast Cancer
409,473 Patients Enrolled for Breast Cancer
Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,519,010 Total Patients Enrolled
61 Trials studying Breast Cancer
111,049 Patients Enrolled for Breast Cancer
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,033 Total Patients Enrolled
33 Trials studying Breast Cancer
4,060 Patients Enrolled for Breast Cancer
University of Texas Southwestern Medical CenterOTHER
1,089 Previous Clinical Trials
1,059,481 Total Patients Enrolled
23 Trials studying Breast Cancer
6,264 Patients Enrolled for Breast Cancer
Loyola UniversityOTHER
160 Previous Clinical Trials
31,254 Total Patients Enrolled
3 Trials studying Breast Cancer
246 Patients Enrolled for Breast Cancer

Media Library

Endocrine Therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02400190 — N/A
Breast Cancer Research Study Groups: Endocrine therapy alone
Breast Cancer Clinical Trial 2023: Endocrine Therapy Highlights & Side Effects. Trial Name: NCT02400190 — N/A
Endocrine Therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02400190 — N/A
~25 spots leftby May 2026
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