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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years of follow up

Awards & highlights

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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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years of follow up

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endocrine therapy aloneExperimental Treatment1 Intervention

Patients receive endocrine therapy alone without radiotherapy

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Harvard UniversityOTHER

229 Previous Clinical Trials

474,381 Total Patients Enrolled

Yale UniversityOTHER

1,847 Previous Clinical Trials

2,736,326 Total Patients Enrolled

27 Trials studying Breast Cancer

3,235 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

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

Journal of Clinical OncologyJournal

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

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.

New England Journal of MedicineJournal

Twenty-year Follow-up of a Randomized Trial Comparing Total Mastectomy, Lumpectomy, and Lumpectomy Plus Irradiation for the Treatment of Invasive Breast Cancer

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.

clinicaltrials.govStudy

The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

2015. "The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02400190.

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