CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

NCT02365714 | Terminated Phase 1 Results DMC

• 1 other identifier: CRC012015-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; DCIS; Invasive Ductal Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Ipsilateral Breast Recurrence

  1 month post radiation treatment through 5 years post treatment

Study Arms (1)

Treatment-Radiation

OTHER

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

Interventions

CK Stereotactic Accelerated Partial Breast Irradiation RADIATION

Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.

Also known as: CyberKnife, SAPBI

Treatment-Radiation

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Hospital

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

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Sonali Rudra, M.D.
• Organization: Medstar Georgetown University Hospital

sonali.rudra@gunet.georgetown.edu

202-444-3320

Study Officials

• Sonali Rudra, M.D.

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)