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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
Postmenopausal status, as defined by patients age 60 or greater, or patients age 50-69 with either s/p bilateral oophorectomy, or intact uterus without menses in the past 12 months, or biochemical confirmation of postmenopausal status
Histopathological confirmation of Stage 1 (pT1N0M0) invasive breast cancer status post breast conserving surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of follow up
Awards & highlights
No Placebo-Only Group

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.

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.Check my eligibility
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.See study design
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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I am postmenopausal, either by age, surgery, or lack of menstruation.
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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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My underarm lymph node examination was done using one of the approved methods.
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My cancer surgery removed the tumor with clear margins of at least 2mm.
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My breast cancer is ER and PR positive but HER2 negative.
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My Oncotype-DX score is 18 or lower.
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My disease is located in only one area, as confirmed by exams and scans.
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I had my last breast cancer surgery less than 90 days ago.
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I am willing to undergo hormone therapy for at least 5 years.
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I've had breast imaging on both breasts within the required time before joining the study.
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I can take care of myself and am up and about more than 50% of my waking hours.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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?

Yale UniversityOTHER
1,828 Previous Clinical Trials
2,716,679 Total Patients Enrolled
27 Trials studying Breast Cancer
3,235 Patients Enrolled for Breast Cancer
Medical College of WisconsinOTHER
601 Previous Clinical Trials
1,161,606 Total Patients Enrolled
13 Trials studying Breast Cancer
409,243 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityOTHER
2,219 Previous Clinical Trials
14,810,365 Total Patients Enrolled
27 Trials studying Breast Cancer
23,448 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many geographic sites are presently conducting this experiment?

"Patients can be enrolled in the trial at Northwell Health, Memorial Sloan Kettering Cancer Center, Rutgers Cancer Institute of New jersey and 13 other sites throughout the US."

Answered by AI

Is this investigation of treatments currently enrolling participants?

"The details posted on clinicaltrials.gov suggest that recruitment for this particular medical trial has been paused since December 16th 2021. Despite the lack of participants at present, there are a plethora of other studies actively welcoming new volunteers right now; over 2200 in total."

Answered by AI

Does this trial include elderly participants?

"This medical study is inviting people aged 50-69 to participate."

Answered by AI

Do I qualify to participate in this clinical research?

"This clinical study is seeking 202 individuals with breast cancer who are postmenopausal and between the ages of 50-69. More specifically, candidates must have had an axillary dissection only for their condition to be considered unifocal on both radiologic and pathologic examination."

Answered by AI
Recent research and studies
~40 spots leftby May 2026