Washington, District of Columbia 20008


Purpose:

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.


Study summary:

Radiotherapy for breast cancer is delivered using several whole breast and partial breast approaches. The optimal approach is unknown. The utilization of partial breast irradiation is growing due to the convenience of fewer fractions versus fifteen- thirty treatments required with conventional or hypofractionated whole breast radiation therapy. Early results with partial breast techniques are promising, showing similar cancer control and toxicity. There is a large body of mature Phase I/II and preliminary Phase III data available exploring the replacement of WBI with an accelerated course of radiation therapy restricted to the region around the tumor bed (accelerated Partial Breast Irradiation, aPBI) using a variety of techniques. For appropriately selected patients treated with modern techniques, the results are encouraging and the techniques have been shown to be safe, tolerable, and highly reproducible with outcomes similar to WBI. Currently, there is limited data assessing the quality of life, cosmetic and oncologic outcomes following stereotactic partial breast irradiation in a large patient population. Our study will be the first essential step in aggregating the outcomes of patients undergoing this type of external beam irradiation in a large patient population.


Criteria:

Inclusion Criteria: - 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 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 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


Study is Available At:


Original ID:

2015-0098


NCT ID:

NCT02457117


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

50 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Georgetown University


Oversight Authority:

United States: Data and Safety Monitoring Board


Reasons Why Stopped:


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Olusola Obayomi-Davies, M.D.
6104465860
olusola.obayomi-davies@crozer.org
Backup Contact:Michael Repka, M.D.
2024443320
michael.c.repka@gunet.georgetown.edu

Study Dates

Start Date:May 2015
Completion Date:June 2020
Completion Type:Anticipated
Primary Completion Date:June 2020
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 15, 2019
First Received Date:May 27, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Adverse reactions
Time Frame:5 years
Safety Issues:False
Description:Toxicity from treatment based on CTCAE version 4.0
Outcome Type:Secondary Outcome
Measure:Distant Recurrence
Time Frame:5 years
Safety Issues:False
Description:Distant disease free interval defined as the time from end of radiation treatment to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary c
Outcome Type:Secondary Outcome
Measure:Regional Recurrence
Time Frame:5 years
Safety Issues:False
Description:Regional recurrence free interval defined as time from end of radiation treatment to the diagnosis of disease in the regional lymph nodes
Outcome Type:Secondary Outcome
Measure:Cosmesis
Time Frame:5 years
Safety Issues:False
Description:Treatment related Cosmesis based on the Harvard Cosmesis Scale
Outcome Type:Primary Outcome
Measure:In breast failure
Time Frame:5 years
Safety Issues:False
Description:To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI

Study Interventions

Intervention Type:Radiation
Name:CyberKnife Stereotactic Accelerated Partial Breast
Description:Five fraction radiation therapy to the lumpectomy cavity
Other Name:Breast SBRT

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Georgetown University

Samples and Retentions

Study Population: Women receiving breast cancer treatment.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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