CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI) (CK-SAPBI)

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; DCIS; Invasive Ductal Carcinoma
• Intervention / Treatment: Radiation: CK Stereotactic Accelerated Partial Breast Irradiation

Detailed Description

This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20008
      • Georgetown University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment-Radiation; CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.	Radiation: CK 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.; Other Names: CyberKnife, SAPBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Enrollment to 24 months
Feasibility	How many patients were able to undergo CK SAPBI	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral Breast Recurrence	No patients have recurred to date.	1 month post radiation treatment through 5 years post treatment

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Sonali Rudra, M.D., Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Carcinoma; Carcinoma, Ductal
• Other Study ID Numbers: CRC012015-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO