A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)

NCT02457117 | Unknown DMC

• 1 other identifier: 2015-0098
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a registry to monitor quality of life and clinical outcomes in patients with clinically localized breast cancer who have received stereotactic accelerated partial breast irradiation via CyberKnife.

Conditions

Breast Cancer

Keywords

CyberKnife; Partial breast irradiation; accelerated partial breast irradiation; breast sbrt

Outcome Measures

Primary Outcomes (1)

• In breast failure

  To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI

  5 years

Secondary Outcomes (4)

• Cosmesis

  5 years

• Regional Recurrence

  5 years

• Distant Recurrence

  5 years

• Adverse reactions

  5 years

Interventions

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

Five fraction radiation therapy to the lumpectomy cavity

Also known as: Breast SBRT, partial breast irradiation

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women receiving breast cancer treatment.

You may qualify if:

• Subjects are eligible to participate in the registry if they receive CK-SAPBI in 5 fractions within 12 weeks of surgery and sign an institution specific consent form.
• Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:
• Newly diagnosed AJCC (seventh edition) 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
• PR positive
• Her2 negative (IHC 0-1+; for IHC 2+, FISH 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 and DCIS by at least 2 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
• Target lumpectomy cavity/whole breast reference volume must be \<30% based on treatment planning CT

You may not qualify if:

• 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 required to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
• Patients with involved axillary nodes.
• Patients with collagen vascular diseases (active).
• Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN, 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20008, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Olusola Obayomi-Davies, M.D.

CONTACT

6104465860; olusola.obayomi-davies@crozer.org

Michael Repka, M.D.

CONTACT

2024443320; michael.c.repka@gunet.georgetown.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 29, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

US (1)