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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01156 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro20150001297 | Other Identifier | IRB Number | |
| Pro20150001297 | Other Identifier | Rutgers Cancer Institute of New Jersey |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| Cianna Medical, Inc. | INDUSTRY |
| Elekta Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated Partial Breast Irradiation | Radiation | Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate, Assessed by Physical Examination | The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Haffty, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Breast Cancer | Gilbert | Arizona | 85297 | United States | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30611839 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 17, 2021 |
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|
| High-Dose Rate Brachytherapy | Radiation | Undergo APBI using HDR brachytherapy |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale | Descriptive statistics reported. | 2 years |
| Local Control Rate, Assessed by Mammography | Assessed using the Kaplan-Meier method. The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods. Tests will be declared statistically significant if the calculated P-value was =< 0.05. All tests appear as 2-sided P-values. | 3 years |
| La Jolla |
| California |
| 92093 |
| United States |
| William Beaumont Hospital Research Institute | Royal Oak | Michigan | 48073 | United States |
| RWJBarnabas Health - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| 21st Centry Oncolgy | Yonkers | New York | 10457 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Huntsman Cancer Hospital, University of Utah | Salt Lake City | Utah | 84112 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | Local Control Rate, Assessed by Physical Examination | The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods. | Data not collected. | Posted | 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale | Descriptive statistics reported. | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Local Control Rate, Assessed by Mammography | Assessed using the Kaplan-Meier method. The association of variables with local regional failure times will be investigated by fitting a parametric model and examining the significance of the parameter estimates. Nonparametric estimates of the survival or recurrence-free distributions or recurrence (failure) distribution will be obtained by life table methods. Tests will be declared statistically significant if the calculated P-value was =< 0.05. All tests appear as 2-sided P-values. | Data not collected. | Posted | 3 years |
|
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Adverse events were collected over a period of two years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Accelerated Partial Breast Irradiation: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy High-Dose Rate Brachytherapy: Undergo APBI using HDR brachytherapy Questionnaire Administration: Ancillary studies | 0 | 200 | 0 | 200 | 165 | 200 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fibrosis deep connective tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dermatitis radiation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Seroma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Reproductive system and breast disorder | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Breast Pain | General disorders | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Haffty | Cancer Institute of New Jersey | 732-235-5203 | hafftybg@cinj.rutgers.edu |
| Jun 22, 2022 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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