Breast Cancer, Ductal Carcinoma in Situ
Conditions
Brief summary
This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (\< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS. Hypotheses: * For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates. * Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy. * Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
Interventions
DEVICEMammosite ML
34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days
Sponsors
Mercy Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women,age of at least 45 years * Zubrod performance status of 0-2 * AJCC Stage I-II (T1-T2, N0 M0) breast cancer * Maximum tumor dimension \< 3 cm * Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies * Unifocal breast cancer * Unilateral breast cancer (no synchronous or previous contralateral breast cancer) * Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm * Ductal Carcinoma In-Situ * Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with \> 6 nodes removed) * Time interval from final breast surgery to brachytherapy loading less than 8 weeks * At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer \> 5 mm) * If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy. * Signed study-specific consent form
Exclusion criteria
* Invasive lobular histology * Non-epithelial breast malignancies such as sarcoma or lymphoma * Multifocal or multicentric invasive carcinoma * Extensive intraductal component (EIC) * Paget's disease of the nipple * Skin involvement by tumor, regardless of tumor size * Positive axillary lymph nodes * Distant metastases * Collagen vascular disease (scleroderma) * Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age) * Any previously treated or synchronous contralateral breast carcinoma * Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent * Men
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral Recurrence Rate | 5 years | * Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume. * Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume. * Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Results | 6 months after treatment, then annually for 5 years | Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation |
| Toxicity Measured Through Adverse Event Incidence | during therapy, 6 weeks after completion of therapy, and additionally as needed | The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sole Method patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS
Mammosite ML: 34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days | 20 |
| Boost patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS
Mammosite ML: 5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx) | 0 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sole Method | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 0 |
| other Total, other adverse events | 1 / 20 | 0 / 0 |
| serious Total, serious adverse events | 0 / 20 | 0 / 0 |
Outcome results
Primary
Ipsilateral Recurrence Rate
* Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume. * Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume. * Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0
Time frame: 5 years
Population: 11 patients within sole method arm were lost to follow-up prior to 5 year follow-up period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sole Method | Ipsilateral Recurrence Rate | 0 participants |
Secondary
Cosmetic Results
Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation
Time frame: 6 months after treatment, then annually for 5 years
Population: No patient information was collected for boost method arm as no patients were enrolled into boost method arm.~11 participants in sole method arm were lost to follow-up over 5 year period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sole Method | Cosmetic Results | Number of pts with good cosmetic results, 5 years post treatment | 6 Participants |
| Sole Method | Cosmetic Results | Number of pts with excellent cosmetic results, 1 year post treatment | 4 Participants |
| Sole Method | Cosmetic Results | Number of pts with good cosmetic results, 1 year post treatment | 14 Participants |
| Sole Method | Cosmetic Results | Number of pts with fair cosmetic results, 1 year post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with poor cosmetic results, 1 year post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with excellent cosmetic results, 2 years post treatment | 4 Participants |
| Sole Method | Cosmetic Results | Number of pts with good cosmetic results, 2 years post treatment | 12 Participants |
| Sole Method | Cosmetic Results | Number of pts with fair cosmetic results, 2 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with poor cosmetic results, 2 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with excellent cosmetic results, 3 years post treatment | 4 Participants |
| Sole Method | Cosmetic Results | Number of pts with good cosmetic results, 3 years post treatment | 10 Participants |
| Sole Method | Cosmetic Results | Number of pts with fair cosmetic results, 3 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with poor cosmetic results, 3 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with excellent cosmetic results, 4 years post treatment | 4 Participants |
| Sole Method | Cosmetic Results | Number of pts with good cosmetic results, 4 years post treatment | 8 Participants |
| Sole Method | Cosmetic Results | Number of pts with fair cosmetic results, 4 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with poor cosmetic results, 4 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with excellent cosmetic results, 5 years post treatment | 3 Participants |
| Sole Method | Cosmetic Results | Number of pts with fair cosmetic results, 5 years post treatment | 0 Participants |
| Sole Method | Cosmetic Results | Number of pts with poor cosmetic results, 5 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with excellent cosmetic results, 5 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with good cosmetic results, 5 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with good cosmetic results, 3 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with excellent cosmetic results, 1 year post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with fair cosmetic results, 4 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with good cosmetic results, 1 year post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with fair cosmetic results, 3 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with fair cosmetic results, 1 year post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with poor cosmetic results, 5 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with poor cosmetic results, 1 year post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with poor cosmetic results, 3 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with excellent cosmetic results, 2 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with poor cosmetic results, 4 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with good cosmetic results, 2 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with excellent cosmetic results, 4 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with fair cosmetic results, 2 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with fair cosmetic results, 5 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with poor cosmetic results, 2 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with good cosmetic results, 4 years post treatment | 0 Participants |
| Boost | Cosmetic Results | Number of pts with excellent cosmetic results, 3 years post treatment | 0 Participants |
Secondary
Toxicity Measured Through Adverse Event Incidence
The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures.
Time frame: during therapy, 6 weeks after completion of therapy, and additionally as needed
Population: No patient information was collected for boost method arm as no patients were enrolled into boost method arm of study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sole Method | Toxicity Measured Through Adverse Event Incidence | 0 Participants |
| Boost | Toxicity Measured Through Adverse Event Incidence | 0 Participants |