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CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

CyberKnife Stereotactic Accelerated Partial Breast Irradiation (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

NCT02365714•Georgetown University

View on ClinicalTrials.gov

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

Age

50 - 99 years

Sex

FEMALE

Healthy Volunteers

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.
+4 more criteria

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.
+5 more criteria

Locations (1)

Georgetown University Hospital

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

Key Dates

Start Date

February 1, 2015

Primary Completion Date

January 1, 2017

Completion Date

January 1, 2017

Last Updated

April 13, 2018

Enrollment

ACTUAL participants

Conditions

Breast CancerDCISInvasive Ductal Carcinoma

Interventions

CK Stereotactic Accelerated Partial Breast Irradiation

RADIATION

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer