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

NCT ID: NCT02526498

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-15
• Study Completion Date: 2021-03-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the toxicity rate with shorter courses of accelerated partial breast irradiation (APBI) delivered with a breast brachytherapy applicator.

SECONDARY OBJECTIVES:

I. To determine the 3-year actuarial local control rate with abbreviated accelerated partial breast irradiation (APBI).

II. To assess the rate of excellent or good cosmesis at 2-years after shorter courses of APBI and to identify co-variants associated with and predictive of poor cosmetic outcome in women treated with an overnight treatment course of APBI.

OUTLINE:

Within 1-5 days after balloon placement, patients undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy over 15-60 minutes for 2-3 days.

After completion of study treatment, patients are followed up at 2-8 weeks and then at least annually for 2 years.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (APBI using HDR brachytherapy)

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

Group Type: EXPERIMENTAL

Accelerated Partial Breast Irradiation

Intervention Type: RADIATION

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

High-Dose Rate Brachytherapy

Intervention Type: RADIATION

Undergo APBI using HDR brachytherapy

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Accelerated Partial Breast Irradiation

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

Intervention Type: RADIATION

High-Dose Rate Brachytherapy

Undergo APBI using HDR brachytherapy

Intervention Type: RADIATION

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

APBI

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

Cianna Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Elekta Limited

INDUSTRY

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Bruce G Haffty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Haffty, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Arizona Breast Cancer

Gilbert, Arizona, United States

University of California, San Diego

La Jolla, California, United States

William Beaumont Hospital Research Institute

Royal Oak, Michigan, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

21st Centry Oncolgy

Yonkers, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Huntsman Cancer Hospital, University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30611839 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

NCI-2015-01156

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro20150001297

Identifier Type: OTHER

Identifier Source: secondary_id

Pro20150001297

Identifier Type: OTHER

Identifier Source: secondary_id

041404

Identifier Type: -

Identifier Source: org_study_id