Breast Cancer, DCIS, Invasive Ductal Carcinoma
Conditions
Brief summary
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.
Detailed description
This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.
Interventions
RADIATIONCK Stereotactic Accelerated Partial Breast Irradiation
Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.
Sponsors
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* -Newly diagnosed Stage 0 or I breast cancer. * On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast * Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy * Age 50 years or greater * ER positive: (≥1% of breast tumor cells express ER in their nuclei) * PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei) * Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified) * Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection. * Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm * Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications. * No involved axillary lymph nodes, N0(i+) allowed * Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery. * Target lumpectomy cavity/whole breast reference volume must be \<30% based on treatment planning CT * Signed study-specific informed consent form
Exclusion criteria
* -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma. * Patients with tumors greater than 2 cm * Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation. * Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy. * Patient with lymphovascular space invasion (LVSI). * Patients with involved axillary nodes. * Patients with collagen vascular diseases. * Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1) * Patients with prior ipsilateral breast irradiation. * Patients with prior ipsilateral thoracic irradiation. * Patients with Paget's disease of the nipple. * Patients with diffuse suspicious microcalcifications. * Patients with suspicious microcalcifications remaining on the post-excision mammogram. * Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy * Patients with oncoplastic reconstruction and absence of surgical clips
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment | Enrollment to 24 months | Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment |
| Feasibility | 2 years | How many patients were able to undergo CK SAPBI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral Breast Recurrence | 1 month post radiation treatment through 5 years post treatment | No patients have recurred to date. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CyberKnife Arm Two patients were enrolled for CyberKnife. In one patient, the fiducials were unable to be tracked, so she received external beam partial breast irradiation. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | CyberKnife Arm |
|---|---|
| Age, Continuous | 59 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Feasibility
How many patients were able to undergo CK SAPBI
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CyberKnife Arm | Feasibility | 1 Participants |
Primary
The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment
Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
Time frame: Enrollment to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CyberKnife Arm | The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment | 2 Participants |
Secondary
Ipsilateral Breast Recurrence
No patients have recurred to date.
Time frame: 1 month post radiation treatment through 5 years post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CyberKnife Arm | Ipsilateral Breast Recurrence | 0 Participants |