Status:
ACTIVE_NOT_RECRUITING
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Collaborating Sponsors:
University of Florence
Conditions:
Breast Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE3
Brief Summary
Rationale and relevance for patients and the scientific community. In low risk early stage patients ≥70 years, exclusive radiation therapy (RT) approach might be superior in terms of Health-Related Qu...
Detailed Description
Study Background. BCS has been established as the preferred treatment option for early stage breast cancer (BC) or for initially inoperable tumors that respond sufficiently to preoperative therapy. BC...
Eligibility Criteria
Inclusion
- Women aged ≥70 years;
- histologically proven invasive adenocarcinoma of the breast;
- pathological T1 (pT1) stage (clinical T1-2 \[cT1-2\] stage is allowed);
- clinical and pathological N0 (cN0 and pN0) stage (isolated tumor cells \[i+\] allowed);
- any tumor grade (if pT ≤10 mm), G1-2 tumor grade (if pT between 11 and 19 mm);
- Luminal-A by immunohistochemistry (IHC)-based on local assessment (consistent with 14th St. Gallen consensus definition):
- ER/PgR+ (defined as ≥10% by IHC staining),
- Human epidermal growth factor receptor 2 (HER2)- (0 or 1+ following IHC staining and proven negative by in-situ hybridization \[ISH\] in case of 2+), and
- Ki67 ≤20% by IHC staining;
- surgically treated with BCS with or without sentinel node biopsy (SNB);
- no clinical evidence of distant metastases. Imaging work up is not mandatory to enter the trial. If there are signs/symptoms suggesting the presence of local relapse or distant metastasis, an appropriate work up should be performed according to the treating physician standard practice. A patient with confirmed local relapse or distant metastasis will no longer be eligible for the trial;
- postoperative final surgical margins negative (no ink on tumor);
- baseline HRQoL questionnaires completion;
- adjuvant bisphosphonates and denosumab are allowed;
- before patient registration/randomization, written informed consent must be given.
Exclusion
- Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy);
- current treatment with any hormonal agents such as tamoxifen, raloxifene or other selective estrogen receptor modulators (SERMs), either for osteoporosis or BC prevention (patients are eligible if these medications are discontinued prior to randomization);
- prior breast or thoracic RT;
- known disorders associated with a higher risk for complications following RT such as collagen vascular disease, dermatomyositis, systemic lupus erythematosis or scleroderma;
- prior diagnosis, detection, or treatment of any other invasive cancer (except basal or squamous cell carcinoma of the skin that has been definitely treated);
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before registration;
- patients must not be considered a poor medical risk due to serious, uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
926 Patients enrolled
Trial Details
Trial ID
NCT04134598
Start Date
February 8 2021
End Date
March 31 2030
Last Update
August 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliero-Universitaria Careggi, Florence University
Florence, Italy, 50141