Recruiting

APBI with SBRT

Sponsor:

RPCR, Inc.

Code:

NCT04985032

Conditions

Ductal Carcinoma in Situ

Invasive Ductal Carcinoma of Female Breast

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

stereotactic body radiation therapy

Study Details

Brief summary:

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

Conditions

Ductal Carcinoma in Situ

Invasive Ductal Carcinoma of Female Breast

Study ID

NCT04985032

Start date

Aug 15, 2022

Status verified date

Aug, 2022

Completion date

Jun, 2027

Anticipated

Primary completion date

Aug 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Women 50 years or older
2. Low to intermediate grade DCIS or invasive ductal carcinoma
3. Tumor size < 2 cm invasive ductal carcinoma and < 2.5 cm DCIS
4. Well defined lumpectomy cavity on CT
5. Clear surgical ink margins > 2mm for invasive cancer and > 3 mm for DCIS
6. Node negative
7. Unifocal lesion
8. ER and/or PR positive
9. HER-2 negative
10. BRCA negative
11. Lumpectomy cavity must be < 30% of whole breast volume

Exclusion Criteria:

1. Lobular histology
2. Angiolymphatic invasion
3. Multiple foci of disease
4. Lymphovascular invasion
5. Active lupus or sarcoid
6. Distant metastases
7. Non-epithelial malignancies
8. Synchronous contralateral breast cancer
9. Grade 2 or higher oncoplastic surgery
10. Ipsilateral pacemaker
11. Ipsilateral breast implant
12. Neoadjuvant chemotherapy
13. Prior ipsilateral breast cancer or thoracic radiation
14. Poor breast integrity
15. Paget's Disease of the nipple
16. Pregnant patients
17. Severe cardiac, pulmonary, or liver diseases

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

stereotactic body radiation therapy

Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less

Primary outcome measure

  • Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS) [ Time Frame: 2-3 years ]
  • Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 1-6 weeks ]
  • Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 3-60 months ]

Central Contacts and Locations

Central contacts

Mark Perman, MD

772-293-0377Mark.Perman@usa.genesiscare.com

Debra Freeman, MD

239-262-5168tbck.md@gmail.com

Locations

CyberKnife Center of South Florida in Stuart

Recruiting

Stuart, Florida, United States, 33996

Contacts

Mark Perman, MD

772-403-2390

Principal Investigator:

Mark Perman, MD

CyberKnife Centers of Tampa Bay

Recruiting

Tampa, Florida, United States, 33615

Contacts

Debra Freeman, MD

813-884-7400dfreeman_md@yahoo.com

Principal Investigator:

Debra Freeman, MD

More Information

Sponsor

RPCR, Inc.

Last update posted

Aug 5, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RPCR, Inc. on 2022-08-05.