Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Paget's Disease, Mammary

Skin Diseases

Neoplastic Processes

Paget Disease of the Breast

adjuvant therapy

conventional surgery

3-dimensional conformal radiation therapy

brachytherapy

intracavitary balloon brachytherapy

proton beam radiation therapy

Lilie Lin, MD

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

OBJECTIVES:

* To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
* To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
* To summarize the institutional experience of these patients treated with this experimental therapy.

OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).

After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.

Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Accelerated Partial Breast Irradiation

National Cancer Institute (NCI)

Abramson Cancer Center at Penn Medicine

Recurrence

Breast Neoplasms, Male

Breast Cancer, Male

Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.

Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.

intraoperative radiation therapy

Janice Lyons, MD

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.

PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

OBJECTIVES:

* To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
* To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
* To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
* To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
* To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
* To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.

OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.

All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins \< 2 mm undergo re-excision of the biopsy cavity.

* Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
* Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.

Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.

Radiation Therapy in Treating Patients With Recurrent Breast Cancer

Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation

Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.

Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision

Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes.

Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast

Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey

Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"

1. I am totally satisfied with the treatment and results
2. I am not totally satisfied but would choose the same treatment again.
3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.
4. I am dissatisfied with my treatment.

Overall complication rate, as measured by percent of participants experiencing complications after intervention

Wound healing rate, as measured by percent of participants with delayed wound healing

Case Comprehensive Cancer Center

Intraoperative Radiation Therapy

Intracavitary Balloon Brachytherapy

Total

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Janice A. Lyons, MD

Ipsilateral Breast Tumor Recurrence Rates

Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.

Intraoperative radiation therapy: Patients undergo radiotherapy

Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.

intracavitary balloon brachytherapy: Patients undergo brachytherapy

Tumor Bed Recurrence Rates

Excellent

Good

Fair

Poor

Baseline

1 Month

3 Months

6 Month

9 Months

12 Months

5 Years

Participants who had data collected for survey. Only participants in group 1 completed survey.

Cosmetic Outcome as Determined by an Established Scale

Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey

Percent of Participants Experiencing Complications After Intervention

Percent of Participants With Delayed Wound Healing

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer	NCT00599989	Breast Cancer Long-term Effec... Skin Reactions ...	adjuvant therap... conventional su... 3-dimensional c... brachytherapy intracavitary b... proton beam rad...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Radiation Therapy in Treating Patients With Recurrent Breast Cancer	NCT00945061	Breast Cancer	intracavitary b... intraoperative ...	18 Years -	Case Comprehensive Cancer Center
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer	NCT00599989	Breast Cancer Long-term Effec... Skin Reactions ...	adjuvant therap... conventional su... 3-dimensional c... brachytherapy intracavitary b... proton beam rad...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Radiation Therapy in Treating Patients With Recurrent Breast Cancer	NCT00945061	Breast Cancer	intracavitary b... intraoperative ...	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for intracavitary balloon brachytherapy