Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Conditions

Breast Cancer

Keywords

breast-conservation, accelerated partial breast irradiation, APBI, IMRT, Intensity modulated radiotherapy, breast brachytherapy, lumpectomy, early stage breast cancer, DCIS, Mammosite

Brief summary

Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.

Smith J, Leonard C, Carter DL, Tole S.

2021-08-29

10.2147/bctt.s318197

Association of the 12-Gene Breast DCIS Score® Assay With Local Recurrence in Patients With Ductal Carcinoma In Situ Treated on Accelerated Partial Breast Radiotherapy Protocols

Charles E. Leonard, Shannon Tole, Michelle Turner, John P. Bennett, Kathryn Howell et al. (6 authors)

Frontiers in Oncology2021-06-174 citations

10.3389/fonc.2021.671047

Outcomes After Accelerated Partial Breast Irradiation in Women With Triple Negative Subtype and Other “High Risk” Variables Categorized as Cautionary in The ASTRO Guidelines

Anabel Goulding, Lina Asmar, Yunfei Wang, Shannon Tole, Lora D. Barke et al. (7 authors)

Frontiers in Oncology2021-03-113 citations

10.3389/fonc.2021.617439

Abstract P2-13-05: Outcomes after accelerated partial breast irradiation in “high risk” and women categorized as cautionary in the ASTRO guidelines

Anabel Goulding, Charles E. Leonard, Shannon Tole, Lora D. Barke, Jodi Widner et al. (7 authors)

Cancer Research2020-02-15

10.1158/1538-7445.sabcs19-p2-13-05

Abstract P4-15-08: Association of OncotypeDX® DCIS ScoreTM results with local recurrence in patients with DCIS treated on accelerated partial breast radiotherapy (APBI) protocols

CE Leonard, SP Fryman, Turner Mp, Bennett Jp, D L Carter et al. (6 authors)

Cancer Research2018-02-15

10.1158/1538-7445.sabcs17-p4-15-08

Interventions

RADIATIONBreast Brachytherapy with Mammosite RTS

Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.

RADIATIONIntensity Modulated Radiotherapy

Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Be a Tis, T1, N0, M0 AJC Classification * Have negative surgical margins (\> or = 2 mm) after final surgery * Should have adequate skin spacing between balloon surface and surface the skin (\> 7 mm)\* * Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease * Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.

Exclusion criteria

* Be pregnant or breast-feeding * Have collagen-vascular disease * Inadequate surgical margins (\< 2 mm) * Patients with malignant/suspicious calcifications

Design outcomes

Primary

Measure	Time frame
Overall Survival	2-15 years
Disease free survival	2-15 years
Cause specific survival	2-15 years
Ipsilateral breast failure	2-15 years

Secondary

Measure	Time frame
Serious Adverse device-related Events	2-5 years

Countries

United States

Outcome results

None listed