Early-stage Breast Cancer, Invasive Ductal Carcinoma of Female Breast
Conditions
Brief summary
This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.
Interventions
RADIATIONPartial Breast Irradiation (PBI)
Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals assigned Female at birth, age 40 and older * Breast conserving surgery without SLNB or ALND * All patients should be capable of giving informed consent, * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Histologically confirmed invasive ductal carcinoma * Individuals with pathologic tumor size \<3cm * Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial. * Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging) * Electrocorticography (ECOG) performance status 0-2
Exclusion criteria
* Male * Transgender or non-binary individuals. * Mastectomy * Metastatic disease * History of ipsilateral or contralateral breast cancer. * Obstacles to obtaining informed consent or undergoing regular follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Axillary Recurrence | Up to Year 5-post-radiation | Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Local Recurrence | Up to Year 5-post-radiation | Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed. |
| Rate of Distant Recurrence | Up to Year 5-post-radiation | Proportion of patients in whom the return of breast cancer to a different area from the original tumor is observed. |
| Breast-Cancer Specific Survival | Up to Year 5-post-radiation | Time from initiation of treatment to death attributed to breast cancer. |
| Overall Survival | Up to Year 5-post-radiation | Time from initiation of treatment to death due to any cause. |
| Rate of Endocrine Therapy Initiation | Up to Year 5-post-radiation | Proportion of patients who initiate endocrine therapy. |
| Rate of Endocrine Therapy Adherence | Up to Year 5-post-radiation | Proportion of patients who display adherence to endocrine therapy following initiation. |
| Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score | Baseline, Year 2 Post-Radiation | BCTOS-13 is a 13-item assessment of aesthetic and functional changes following breast-conserving therapy. Each item is rated on a Likert scale from 1-4; the total score is the average of the item responses and ranges from 1.0 - 4.0. Lower scores indicate a better outcome, meaning the patient perceives less difference between the treated and untreated breast |
| Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT) | Baseline, Year 2 Post-Radiation | OST-FACIT is a patient-reported questionnaire designed to measure the financial distress and hardship caused by medical treatments for chronic illnesses. 11 items are rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-44. Higher scores indicate less financial distress. |
Countries
United States
Contacts
CONTACTCancerTrials Inbox
PRINCIPAL_INVESTIGATORNaamit Gerber, MD
NYU Langone Health
Outcome results
None listed