Phase
Condition
Breast Cancer
Cancer
Treatment
Adjuvant Radiotherapy
Clinical Study ID
Ages > 60 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of pathologically-confirmed invasive breast cancer
Age ≥ 60 years
Treatment with breast conserving surgery
Pathologic T stage of T1 or T2 with total tumor size ≤ 3cm including any componentof DCIS that may exist in conjunction with invasive disease
Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma insitu involving the final surgical margin will be disregarded.
Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neunon-amplified as per current College of American Pathologists guidelines
Clinical nodal stage cN0
If pathologic nodal staging is obtained, then pN0 or pN0(i+)
Patients have had or have a scheduled discussion with a breast medical oncologistregarding adjuvant treatment options
Patients who have met criteria 4.1.1-4.1.9 who never initiate endocrine therapy ORwho initiate adjuvant endocrine therapy but discontinue it within 6 months ofinitiation * In some clinical scenarios, patients may have a particularly smallvolume of tumor, making it not be feasible for all of these biomarkers to beevaluated. In this scenario, if the PI and/or Protocol Collaborators are able todocument that a patient is being treated as if they have luminal A (biologicallyfavorable) breast cancer then the patient is eligible for enrollment if all othereligibility criteria are met.
Exclusion
Exclusion Criteria:
Node positive disease (N1-3)
Metastatic disease (M1)
Grade 3 disease and lymphovascular space invasion in the tumor
Synchronous bilateral breast cancer
Receipt of neoadjuvant therapy
Diagnosis of a collagen vascular disease associated with an increased incidence ofradiation toxicities such as scleroderma or systemic lupus erythematosis
Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cellcarcinoma of the skin that has been treated
Patient with psychiatric illness/social situations that would limit compliance withstudy requirements
Prior radiotherapy to the index breast or recurrent cancer of the breast
Known carrier of a mutation associated with predisposition to breast cancerdevelopment, including BRCA1 or BRCA2
Study Design
Study Description
Connect with a study center
The University of Texas M. D. Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The University of Texas M. D. Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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