Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

NCT04985032 | Recruiting DMC

• 1 other identifier: RPCR-breast 01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)

  physician and patient assessment of breast cosmetic result following SBRT

  2-3 years

• Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  assessment of skin and breast tissue changes during and immediately following SBRT

  1-6 weeks

• Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  assessment of pulmonary, cardiac and chest wall changes following SBRT

  3-60 months

Interventions

stereotactic body radiation therapy RADIATION

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

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SBRT for treatment of the surgical cavity following partial mastectomy for women with early-stage breast cancer will be studied.

You may qualify if:

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

You may not qualify if:

• Lobular histology
• Angiolymphatic invasion
• Multiple foci of disease
• Lymphovascular invasion
• Active lupus or sarcoid
• Distant metastases
• Non-epithelial malignancies
• Synchronous contralateral breast cancer
• Grade 2 or higher oncoplastic surgery
• Ipsilateral pacemaker
• Ipsilateral breast implant
• Neoadjuvant chemotherapy
• Prior ipsilateral breast cancer or thoracic radiation
• Poor breast integrity
• Paget's Disease of the nipple

Sponsors & Collaborators

• RPCR, Inc.: lead
• CyberKnife Coalition: collaborator

Study Sites (2)

CyberKnife Center of South Florida in Stuart

Stuart, Florida, 33996, United States

RECRUITING

CyberKnife Centers of Tampa Bay

Tampa, Florida, 33615, United States

RECRUITING

Related Publications (12)

• National Comprehensive Cancer Network. Invasive Breast Cancer (Version 1.2021) https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

  BACKGROUND

• 2Bonfantini F, De Martin E, Giandini T, Fumagalli ML, Cavallo A, Pinzi V, et al. A Dosimetric Comparison between Three Different External Photon Beam Techniques for Accelerated Partial Breast Irradiation. Clin Oncol. 2018; 3:1501.

  BACKGROUND

• Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.

  PMID: 19395195 BACKGROUND

• Wolmark N, Curran WJ, Vicini F, White J, Costantino JP, Arthur D, Kuske R, Rabinovitch R, Julian TB, Parda DS. Response to "Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation" (Int J Radiat Oncol Biol Phys 2010;76:71-78) and "Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation" Int J Radiat Oncol Biol Phys 2009;75:1290-1296). Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):317; author reply 318. doi: 10.1016/j.ijrobp.2009.12.033. No abstract available.

  PMID: 20394863 BACKGROUND

• Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5.

  PMID: 31813635 BACKGROUND

• Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial. Lancet. 2019 Dec 14;394(10215):2155-2164. doi: 10.1016/S0140-6736(19)32514-0. Epub 2019 Dec 5.

  PMID: 31813636 BACKGROUND

• 7White J. Cosmetic Outcomes from Post Lumpectomy Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) on the NRG Oncology/NSABP B39-RTOG 0413 Phase III Clinical Trial. ASTRO Annual Meeting. November 10, 2019.

  BACKGROUND

• Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.

  PMID: 28779963 BACKGROUND

• Meattini I, Marrazzo L, Saieva C, Desideri I, Scotti V, Simontacchi G, Bonomo P, Greto D, Mangoni M, Scoccianti S, Lucidi S, Paoletti L, Fambrini M, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Pallotta S, Livi L. Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial. J Clin Oncol. 2020 Dec 10;38(35):4175-4183. doi: 10.1200/JCO.20.00650. Epub 2020 Aug 24.

  PMID: 32840419 BACKGROUND

• Hoekstra N, Habraken S, Swaak-Kragten A, Breedveld S, Pignol JP, Hoogeman M. Reducing the Risk of Secondary Lung Cancer in Treatment Planning of Accelerated Partial Breast Irradiation. Front Oncol. 2020 Aug 18;10:1445. doi: 10.3389/fonc.2020.01445. eCollection 2020.

  PMID: 33014782 BACKGROUND

• Rahimi A, Thomas K, Spangler A, Rao R, Leitch M, Wooldridge R, Rivers A, Seiler S, Albuquerque K, Stevenson S, Goudreau S, Garwood D, Haley B, Euhus D, Heinzerling J, Ding C, Gao A, Ahn C, Timmerman R. Preliminary Results of a Phase 1 Dose-Escalation Trial for Early-Stage Breast Cancer Using 5-Fraction Stereotactic Body Radiation Therapy for Partial-Breast Irradiation. Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):196-205.e2. doi: 10.1016/j.ijrobp.2017.01.020. Epub 2017 Jan 12.

  PMID: 28586960 BACKGROUND

• Rahimi A, Morgan HE, Kim DW, Zhang Y, Leitch M, Wooldridge R, Goudreau S, Haley B, Rao R, Rivers A, Spangler AE, Jones RT, Stevenson S, Staley J, Albuquerque K, Ahn C, Neufeld S, Alluri PG, Ding C, Garwood D, Seiler S, Zhao B, Gu X, Timmerman R. Cosmetic Outcomes of a Phase 1 Dose Escalation Study of 5-Fraction Stereotactic Partial Breast Irradiation for Early Stage Breast Cancer. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):772-782. doi: 10.1016/j.ijrobp.2021.01.015. Epub 2021 Jan 18.

  PMID: 33476737 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mark Perman, MD

CONTACT

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

Debra Freeman, MD

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: August 15, 2022
• Primary Completion: August 15, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

US (2)