Breast Cancer
Conditions
Keywords
invasive ductal cancer, tubular breast cancer, breast cancer, colloid, ER positive, radiation
Brief summary
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
Interventions
RADIATIONAccelerated partial breast irradiation
Accuboost APBI 34.0 Gy in 10 fractions
OTHERExtended Follow up
This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.
Sponsors
The Miriam Hospital
Rhode Island Hospital
Jaroslaw Hepel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS 2. Age greater or equal to 50 years old 3. Life expectancy \> 6 months 4. Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy 5. Pathologic tumor size less than or equal to 2 cm 6. Invasive ductal, mucinous, tubular or colloid histology 7. Estrogen receptor positive for invasive carcinoma. 8. Unifocal/unicentric disease 9. Negative surgical margins greater than or equal to 2 mm 10. Pathologic lymph node negative 11. No evidence of lymphovascular invasion 12. ECOG performance status of 0 or 1 (Appendix 1) 13. Informed consent signed.
Exclusion criteria
1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required) 2. Autoimmune disorder 3. Pregnancy 4. Breast implants 5. Psychiatric or addictive disorder that would preclude attending follow-up 6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted) 7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign) 8. Lobular features on histology (pure or mixed) or sarcoma histology 9. Node positive on axillary dissection or in the sentinel lymph node biopsy; 10. Extensive in situ carcinoma (EIC) 11. Multicentric or multifocal disease 12. Paget's disease of the nipple 13. Distant metastases 14. Lumpectomy cavity not well visualized on AccuBoost imaging 15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV \> 6cm) 16. Breast separation with compression \> 7cm. 17. Overlap of skin between orthogonal treatment axes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early and Intermediate Toxicity | 2 years | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome | 2 years | Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table. |
Countries
United States
Participant flow
Pre-assignment details
40 patients must COMPLETE treatment. 41 were registered because 1 was removed secondary to Physician decision to not continue treatment.
Participants by arm
| Arm | Count |
|---|---|
| Radiation AccuBoost APBI- 34.0 Gy in 10fx
Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 61.46 years |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 41 |
| serious Total, serious adverse events | 1 / 41 |
Outcome results
Primary
Early and Intermediate Toxicity
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation | Early and Intermediate Toxicity | 40 participants |
| Extended to 5 Years of Follow Up-Rhode Island Hospital Only | Early and Intermediate Toxicity | 28 participants |
Secondary
Cosmetic Outcome
Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiation | Cosmetic Outcome | 35 participants |