CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

Breast Cancer Clinical Trial

— CK-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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02365714
• Other study ID #: CRC012015-02
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 11, 2015
• Last updated: March 16, 2018
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal
• DCIS
• Invasive Ductal Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Enrollment to 24 months
Primary	Feasibility	How many patients were able to undergo CK SAPBI	2 years
Secondary	Ipsilateral Breast Recurrence	No patients have recurred to date.	1 month post radiation treatment through 5 years post treatment