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Title:
“The IDEA Study (Individualized Decisions for Endocrine therapy Alone): A prospective, single-arm cohort study of patients receiving endocrine therapy alone (without radiotherapy) after breast conserving surgery for early-stage, post-menopausal breast cancer patients whose tumors have favorable biologic features”
Protocol Number:
J1564
Phase:
Phase II
Physician:
Jean Wright
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Suburban Hospital
Sibley Memorial Hospital
Purpose:
This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.
Eligibility:
Ages Eligible for Study: 50 Years to 69 YearsGenders Eligible for Study: FemaleAccepts Healthy Volunteers: N0Inclusion Criteria:Postmenopausal status, as defined by (a) patients age 60 or greater, or, (b) patients age 50-69 with either (a) s/p bilateral oophorectomy, or, (b) intact uterus without menses in the past 12 months, or, (c) biochemical confirmation of postmenopausal status.Histopathological confirmation of Stage 1 (pT1N0M0) invasive breast cancer status post breast conserving surgeryNegative axillary nodes (isolated tumor cells with no cluster measuring greater than 0.2mm allowed)Allowable options for axillary staging include:Sentinel node biopsy onlySentinel node biopsy followed by axillary dissectionAxillary dissection onlyMargins of excision equal to 2mmER+, PR+, Her2 - using the current College of American Pathologists guidelinesOncotype-DX RS equal to 18Disease must be unifocal on clinical, radiologic, and pathologic examinationRegistration within 90 days of last surgical procedure for breast cancer treatmentPatient must willingly sign study specific informed consent prior to study entryPatient must be a candidate for and willing to take endocrine therapy for minimum of 5 years (aromatase inhibitor or tamoxifen). Patients who have already begun endocrine therapy after lumpectomy are eligible.Patient must have had a bilateral mammogram within 120 days of study entry.Patient must have Zubrod performance status 0-2Exclusion Criteria:Evidence of multifocal or multicentric breast cancer that has not been biopsy-proven negative. Note that MRI is not required for this study, but if performed, evidence of disease beyond the site of the primary tumor in the ipsilateral breast or in the contralateral breast must be biopsy-proven not to be malignant before registration.Metastatic disease. Note that no specific staging studies are mandated, but any studies performed must not provide clear evidence of metastatic spread.Previous radiation therapy to the breast regionPrior DCIS or invasive breast cancerBilateral breast cancerPrior non-breast invasive malignancy other than non-melanoma skin cancer, unless there has been no evidence of disease for at least 5 yearsKnown carrier of a mutation known to predispose towards breast cancer development (including BRCA-1 and BRCA-2). Note: testing for mutation status is not required for this protocol; this criterion applies only to patients who have been tested and have known carrier status.
Treatment:
The primary objective of this trial is to measure the local and regional recurrence (LRR) rate after 5 years of follow-up. The secondary objectives of this trial are to quantify the rate of salvage mastectomy and other salvage therapies in this setting (if necessary), and to evaluate the rate of compliance with endocrine therapy over the 5 years of follow-up. The study is not designed to test a specific hypothesis, but rather to inform the design of a future cooperative group, randomized trial that will ultimately settle the question of whether radiotherapy is necessary in this select group of favorable-risk patients. To accomplish these goals we will accrue approximately 25 women at our institution, meeting the eligibility criteria set forth, over a period of approximately 2 years. Data from these patients will be analyzed together with that from patients enrolled at multiple other collaborating institutions (with a total cohort size of 200). Those patients will be followed for their clinical outcome for at least 10 years, specifically: for development of local or regional recurrence, the salvage therapy type if local disease recurs, for development of distant metastasis, and survival – both overall and breast-cancer specific.
Population:
Adult
Last Update
03/05/2019 05:03 AM