Clinical trial NCT02365714: CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)
Official title: A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
DCIS
Invasive Ductal Carcinoma
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 2
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Enrollment to 24 months
measure: Feasibility
timeFrame: 2 years
Secondary outcomes:
measure: Ipsilateral Breast Recurrence
timeFrame: 1 month post radiation treatment through 5 years post treatment
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University Hospital
name: Sonali Rudra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: