Clinical trial NCT02400190: The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
Official title: The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: radiation
lumpectomy
favorable biology
omission
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: East Carolina University
name: Stanford University
name: Harvard University
name: Yale University
name: University of Pennsylvania
name: Medical College of Wisconsin
name: Memorial Sloan Kettering Cancer Center
name: University of Texas Southwestern Medical Center
name: Johns Hopkins University
name: Loyola University
First posted: 2015-03-26
Enrollment: 202
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study's primary aim is to determine rates of recurrence with the innovative approach of considering tumor biology to select patients who may avoid radiation, with restriction of eligibility to women aged 50-69 with hormone-sensitive, Her2-negative tumors with Oncotype-DX RS ≤ 18 who plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at low risk of LRR in whom omission of adjuvant radiation is reasonable.

Eligibility criteria: Inclusion 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 surgery
* Negative axillary nodes (isolated tumor cells with no cluster measuring \>0.2mm allowed)

  * Allowable options for axillary staging include:
  * Sentinel node biopsy only
  * Sentinel node biopsy followed by axillary dissection
  * Axillary dissection only
* Margins of excision ≥2mm
* ER+, PR+, Her2 - using the current College of American Pathologists guidelines
* Oncotype-DX RS ≤ 18
* Disease must be unifocal on clinical, radiologic, and pathologic examination
* Registration within 90 days of last surgical procedure for breast cancer treatment
* Patient must willingly sign study specific informed consent prior to study entry
* Patient 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 breast imaging (mammogram or MRI) of the ipsilateral breast within 6 months and contralateral breast within 1 year of study entry.
* Patient must have Zubrod performance status 0-2

Exclusion 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 region
* Prior DCIS or invasive breast cancer
* Bilateral breast cancer
* Prior non-breast invasive malignancy other than non-melanoma skin cancer, unless there has been no evidence of disease for at least 5 years
* Known 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.

Primary outcomes:
measure: Loco-regional Recurrence
timeFrame: 5 years of follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Michigan
name: Reshma Jagsi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP, Watson D, Geyer CE Jr, Wickerham DL, Wolmark N. 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. J Clin Oncol. 2010 Apr 1;28(10):1677-83. doi: 10.1200/JCO.2009.23.7610. Epub 2010 Jan 11.
citation: Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.