The IDEA Study (Individualized Decisions for Endocrine Therapy Alone)

University of Michigan Rogel Cancer Center

Status

Active, not recruiting

Conditions

Breast Neoplasms

Treatments

Other: endocrine therapy alone without radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02400190

HUM00092923 (Other Identifier)

UMCC 2014.111

Details and patient eligibility

About

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.

Full 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.

Enrollment

202 patients

Sex

Female

Ages

50 to 69 years old

Volunteers

No Healthy Volunteers

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.