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
Conditions
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.
Interventions
RADIATIONAccelerated Partial Breast Irradiation
Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy
RADIATIONHigh-Dose Rate Brachytherapy
Undergo APBI using HDR brachytherapy
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Rutgers Cancer Institute of New Jersey
Cianna Medical, Inc.
Elekta Limited
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Control Rate, Assessed by Physical Examination | 3 years | 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. |
| Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale | 2 years | Descriptive statistics reported. |
| Local Control Rate, Assessed by Mammography | 3 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 200 |
| Total | 200 |
Baseline characteristics
| Characteristic | Treatment (APBI Using HDR Brachytherapy) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 135 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 185 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male Female | 200 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 165 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (APBI Using HDR Brachytherapy) | 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 | 200 Participants |
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.
Time frame: 3 years
Population: Data not collected.
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.
Time frame: 3 years
Population: Data not collected.
Secondary
Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale
Descriptive statistics reported.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (APBI Using HDR Brachytherapy) | Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale | 177 Participants |