Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

Conditions

Breast Cancer

Keywords

breast-conservation, adjuvant radiotherapy, breast cancer, early-stage breast cancer, DCIS, lumpectomy, accelerated partial breast irradiation, APBI, three dimensional conformal external radiotherapy, intensity modulated radiotherapy, 3D CRT, IMRT

Brief summary

In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.

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

RADIATIONaccelerated partial breast irradiation - 3D-conformal planning

38.5 Gy, 10 fractions over 5 days

RADIATIONaccelerated partial breast irradiation - IMRT planning

38.5 Gy, 10 fractions over 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Histologically confirmed disease (AJC Classification): Tis, T1, T2 (≤ 3.0 cm), N0, M0. * Microscopic multifocal disease is only allowed when the entire span of identified disease measures 3.0 cm or less. * Negative surgical margins ( ≥ 0.2 cm) after final surgery. * Subjects with infiltrating lobular histologies or high nuclear grade DCIS will be required to have breast MRI scanning as part of the initial staging to verify localized disease. * Subjects with DCIS will be included in the study only if they had an MRI prior to lumpectomy. * Findings on MRI scanning revealing relevant suspicion of disease outside of planned lumpectomy volume should be further evaluated by ultrasound and, if necessary biopsy, to exclude multicentric/multifocal disease. * Subjects with malignant calcifications on mammography will be required to have repeat mammography after surgery to ensure removal of all malignant calcifications. * Willing to complete additional screening requirements and meet eligibility criteria as defined in protocol Sec. 4.4. * Successful placement of fiducial markers for IGRT requiring nonmigrating fiducials. * PTV to ipsilateral breast ratio (IBR) ≤ 25 %. * Radiotherapy anticipated to begin within 10 weeks of lumpectomy or re-excision of margins.

Exclusion criteria

* Pregnancy or breast-feeding. * Have collagen-vascular disease. * Inadequate surgical margins ( \< 0.2 cm) after final surgery. * Subjects with persistent malignant/suspicious micro-calcifications. * Gross multifocal disease and microscopic disease greater than 3.0 cm.

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)	5 years	Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)	2-5 years	Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit

Secondary

Measure	Time frame	Description
Cosmetic outcomes after APBI	2-5 years	Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit
Ipsilateral breast event	5-15 years	Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)
Dosimetric comparison	5-10 days	Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue
Disease free survival	5-15 years	Track breast-cancer free survival status of study participants (efficacy outcome measure)
Overall survival	5-15 years	Track the overall survival status of all study participants (efficacy outcome measure)
Cause specific survival	5-15 years	Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)
Acute skin reactions	6 months	Radiation-induced dermatitis

Countries

United States

Contacts

Primary ContactRachel Lei, BS

rachel.lei@usoncology.com303-418-7607

Backup ContactCharles Leonard, MD

303-730-4700

Outcome results

None listed