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.
Brief Title
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
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.
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.
Categories
Completion Date
Completion Date Type
Actual
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
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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
45 Years
NCT Id
NCT02526498
Org Class
Other
Org Full Name
Rutgers, The State University of New Jersey
Org Study Id
041404
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)
Primary Outcomes
Outcome Description
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.
Outcome 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
Outcome Time Frame
2 years
Secondary Ids
Secondary Id
NCI-2015-01156
Secondary Id
Pro20150001297
Secondary Id
Pro20150001297
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
3 years
Outcome Measure
Local Control Rate, Assessed by Physical Examination
Outcome Description
Descriptive statistics reported.
Outcome Time Frame
2 years
Outcome Measure
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
Outcome Description
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.
Outcome Time Frame
3 years
Outcome Measure
Local Control Rate, Assessed by Mammography
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
45
Investigators
Investigator Type
Principal Investigator
Investigator Name
Keyur Mehta
Investigator Email
kmehta@montefiore.org
Investigator Phone
718-405-8560