Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Study Overview
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Brief Summary
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To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.

Official Title
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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Conditions
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Breast Cancer, Carcinoma, Ductal

Intervention / Treatment
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* Radiation: Intra-Operative Radiotherapy (IORT)
* Procedure: Lumpectomy
* Radiation: Whole Breast Radiotherapy
* Radiation: Intracavitary Brachytherapy
* Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
* Radiation: Stereotactic APBI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen. Exclusion Criteria: Men Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years Pregnant women Immunocompromised Poorly controlled insulin dependent diabetes Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma Breast cancer that involves skin or chest wall Multifocal or Multicentric breast cancer Invasive lobular carcinoma Diffuse microcalcifications on mammography Invasive carcinoma with extensive intraductal component (EIC) Greater than 12 weeks since definitive surgical excision or completion of chemotherapy Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases) Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated Partial Breast Irradiation<br>lumpectomy with accelerated partial breast irradiation | Radiation: Intra-Operative Radiotherapy (IORT)<br>* single dose in the operating room after lumpectomy<br>Procedure: Lumpectomy<br> <br> Radiation: Intracavitary Brachytherapy<br>* 5 day treatment<br>* Other names: MammoSite;Radiation: Accelerated External Beam 3-D Conformal Radiotherapy<br>* 5 day treatment<br>Radiation: Stereotactic APBI<br>* 4 day treatment<br>|
| Active Comparator: Standard Therapy<br>lumpectomy and whole breast irradiation | Procedure: Lumpectomy<br> <br> Radiation: Whole Breast Radiotherapy<br>* six and a half week treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-breast tumor recurrence (IBTR) | Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029 | 20 years |