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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: intraoperative radiation therapy; Radiation: intracavitary balloon brachytherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44122
      • UHHS Chagrin Highlands Medical Center
    • Cleveland, Ohio, United States, 44145
      • UHHS Westlake Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
• Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
• Unifocal breast cancer recurrence
• Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
• Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
• Signed study-specific informed consent prior to study entry.

Exclusion Criteria:

• Patients with distant metastatic disease
• Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
• Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
• Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
• Patients with Paget's disease of the nipple.
• Patients with skin involvement.
• Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
• Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
• Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.
• Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
• Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative radiation therapy; Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	Radiation: intraoperative radiation therapy; Patients undergo radiotherapy
Experimental: Intracavitary balloon brachytherapy; Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	Radiation: intracavitary balloon brachytherapy; Patients undergo brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral Breast Tumor Recurrence Rates	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.	1 month after radiation therapy (RT)
Ipsilateral Breast Tumor Recurrence Rates	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.	3 months after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	6 months after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	9 months after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	12 months after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	2 years after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	3 years after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	4 years after RT
Ipsilateral Breast Tumor Recurrence Rates	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.	5 years after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	1 month after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	3 month after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	6 month after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	12 month after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	2 years after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	3 years after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	4 years after RT
Tumor Bed Recurrence Rates	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	5 years after RT
Cosmetic Outcome as Determined by an Established Scale	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	1 month after RT & Q3mos for one year and at 5 years
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	1 month after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	3 month after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	6 month after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	9 month after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	12 month after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	2 years after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	3 years after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	4 years after RT
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 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"; I am totally satisfied with the treatment and results; I am not totally satisfied but would choose the same treatment again.; 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.; I am dissatisfied with my treatment.	5 years after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	1 month after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	3 month after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	6 month after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	9 month after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	12 month after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	2 years after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	3 years after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	4 years after RT
Percent of Participants Experiencing Complications After Intervention	Overall complication rate, as measured by percent of participants experiencing complications after intervention	5 years after RT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	1 month after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	3 month after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	6 month after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	9 month after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	12 month after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	2 years after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	3 years after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	4 years after RT
Percent of Participants With Delayed Wound Healing	Wound healing rate, as measured by percent of participants with delayed wound healing	5 years after RT

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Janice Lyons, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2008
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: recurrent breast cancer; male breast cancer; ductal breast carcinoma in situ; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE11107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No