Clinical trial NCT02526498: Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
Official title: TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: Cianna Medical, Inc.
name: Elekta Limited
First posted: 2015-08-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Local Control Rate, Assessed by Physical Examination
timeFrame: 3 years
measure: Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
timeFrame: 2 years
measure: Local Control Rate, Assessed by Mammography
timeFrame: 3 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arizona Breast Cancer
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Royal Oak
country: United States
facility: William Beaumont Hospital Research Institute
state: Michigan
city: New Brunswick
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Yonkers
country: United States
facility: 21st Centry Oncolgy
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital, University of Utah
state: Utah
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Bruce Haffty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.