Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery

NCT02526498 | Completed Phase 2 Results DMC FDA Device

• 3 other identifiers: 041404NCI-2015-01156Pro20150001297
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type of internal radiation therapy that provides radiation inside the breast to any remaining tumor cells next to the space where the tumor was removed, and is given over a shorter amount of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is delivered to the tumor cells.

Conditions

Ductal Breast Carcinoma In Situ; Estrogen Receptor Positive; Invasive Breast Carcinoma; Progesterone Receptor Positive; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Greater Than Grade 2 Serious Toxicity Rate, Defined as Toxicity Greater Than Grade 2 Using Common Terminology Criteria for Adverse Events Version 4.0 Criteria

  Measured by the data collected for toxicity and cosmesis as dichotomous variables. This will be assessed by physical examination at each follow-up visit. To be scored as a serious toxicity counting toward the primary endpoint, the toxicity must have a "probable" or "definite" attribution to the study treatment.

  2 years

Secondary Outcomes (3)

• Local Control Rate, Assessed by Physical Examination

  3 years

• Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale

  2 years

• Local Control Rate, Assessed by Mammography

  3 years

Study Arms (1)

Treatment (APBI using HDR brachytherapy)

EXPERIMENTAL

Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.

Radiation: Accelerated Partial Breast Irradiation; Radiation: High-Dose Rate Brachytherapy; Other: Questionnaire Administration

Interventions

Accelerated Partial Breast Irradiation RADIATION

Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy

Also known as: APBI

Treatment (APBI using HDR brachytherapy)

High-Dose Rate Brachytherapy RADIATION

Undergo APBI using HDR brachytherapy

Treatment (APBI using HDR brachytherapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (APBI using HDR brachytherapy)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must sign informed consent
• Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (negative surgical margins per National Surgical Adjuvant Breast and Bowel Project \[NSABP\] criteria)
• On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma
• For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy \[SNB\] alone or axillary dissection \[with a minimum of six axillary nodes removed\], and the axillary node\[s\] must be pathologically negative); patients over 70 with estrogen receptor positive (ER+) tumors no greater than 2 cm do not require axillary evaluation, but MUST be clinically node negative on examination and all available imaging (clinical N0)
• The T stage must be Tis, T1, or T2; if T2, the tumor must be =\< 3.0 cm in maximum diameter
• Estrogen receptor positive tumor and/or progesterone receptor positive tumor

You may not qualify if:

• Pregnant or breast-feeding
• Active collagen-vascular disease
• Paget's disease of the breast
• Prior history of DCIS or invasive breast cancer
• Prior breast or thoracic radiation therapy (RT) for any condition
• Multicentric carcinoma (DCIS or invasive)
• Synchronous bilateral invasive or non-invasive breast cancer
• Surgical margins that cannot be microscopically assessed or that are positive
• Positive axillary node(s)
• T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage \>= 3
• Estrogen receptor negative and progesterone receptor negative tumor
• Any of the dosimetric treatment criteria as defined have not been met; patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as defined in this protocol and will come off the study; any subsequent adjuvant radiation will be delivered at the discretion of the treating physician

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Rutgers Cancer Institute of New Jersey: collaborator
• Cianna Medical, Inc.: collaborator
• Elekta Limited: collaborator

Study Sites (10)

Arizona Breast Cancer

Gilbert, Arizona, 85297, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

William Beaumont Hospital Research Institute

Royal Oak, Michigan, 48073, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

21st Centry Oncolgy

Yonkers, New York, 10457, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Huntsman Cancer Hospital, University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Khan AJ, Chen PY, Yashar C, Poppe MM, Li L, Abou Yehia Z, Vicini FA, Moore D, Dale R, Arthur D, Shah C, Haffty BG, Kuske R. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):67-74. doi: 10.1016/j.ijrobp.2018.12.050. Epub 2019 Jan 4.

  PMID: 30611839 DERIVED

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

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; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bruce Haffty
• Organization: Cancer Institute of New Jersey

hafftybg@cinj.rutgers.edu

732-235-5203

Study Officials

• Bruce Haffty, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 18, 2015
• Study Start: July 15, 2015
• Primary Completion: August 18, 2017
• Study Completion: March 31, 2021
• Last Updated: May 15, 2023
• Results First Posted: August 16, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)