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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945061

Enrollment

Registered

2009-07-23

Start date

2008-09-23

Completion date

2018-07-06

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ, recurrent breast cancer, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, male breast cancer

Brief summary

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.

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.

Interventions

RADIATIONintracavitary balloon brachytherapy

Patients undergo brachytherapy

RADIATIONintraoperative radiation therapy

Patients undergo radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Ipsilateral Breast Tumor Recurrence Rates	1 month after radiation therapy (RT)	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.
Tumor Bed Recurrence Rates	1 month after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision
Cosmetic Outcome as Determined by an Established Scale	1 month after RT & Q3mos for one year and at 5 years	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 Quality of Life (QOL) Survey	1 month after RT	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.
Percent of Participants Experiencing Complications After Intervention	1 month after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention

Secondary

Measure	Time frame	Description
Percent of Participants With Delayed Wound Healing	1 month after RT	Wound healing rate, as measured by percent of participants with delayed wound healing

Countries

United States

Participant flow

Participants by arm

Arm	Count
Intraoperative Radiation Therapy Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	12
Intracavitary Balloon Brachytherapy Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	1
Total	13

Baseline characteristics

Characteristic	Intraoperative Radiation Therapy	Intracavitary Balloon Brachytherapy	Total
Age, Customized 40-49 years	1 Participants	0 Participants	1 Participants
Age, Customized 50-59 years	4 Participants	0 Participants	4 Participants
Age, Customized 60-69 years	4 Participants	1 Participants	5 Participants
Age, Customized 70-79 years	1 Participants	0 Participants	1 Participants
Age, Customized 80-89 years	2 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	1 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	0 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	9 Participants	1 Participants	10 Participants
Region of Enrollment United States	12 participants	1 participants	13 participants
Sex: Female, Male Female	12 Participants	1 Participants	13 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 12	0 / 1
other Total, other adverse events	11 / 12	1 / 1
serious Total, serious adverse events	0 / 12	0 / 1

Outcome results

Primary

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

Time frame: 1 month after RT & Q3mos for one year and at 5 years

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

Arm	Measure	Group	Value (NUMBER)
Intraoperative Radiation Therapy	Cosmetic Outcome as Determined by an Established Scale	Good	54 percentage of participants
Intraoperative Radiation Therapy	Cosmetic Outcome as Determined by an Established Scale	Fair	38 percentage of participants
Intraoperative Radiation Therapy	Cosmetic Outcome as Determined by an Established Scale	Poor	0 percentage of participants
Intraoperative Radiation Therapy	Cosmetic Outcome as Determined by an Established Scale	Excellent	8 percentage of participants
Intracavitary Balloon Brachytherapy	Cosmetic Outcome as Determined by an Established Scale	Fair	50 percentage of participants
Intracavitary Balloon Brachytherapy	Cosmetic Outcome as Determined by an Established Scale	Excellent	0 percentage of participants
Intracavitary Balloon Brachytherapy	Cosmetic Outcome as Determined by an Established Scale	Poor	0 percentage of participants
Intracavitary Balloon Brachytherapy	Cosmetic Outcome as Determined by an Established Scale	Good	50 percentage of participants
3 Months	Cosmetic Outcome as Determined by an Established Scale	Fair	37 percentage of participants
3 Months	Cosmetic Outcome as Determined by an Established Scale	Good	37 percentage of participants
3 Months	Cosmetic Outcome as Determined by an Established Scale	Excellent	13 percentage of participants
3 Months	Cosmetic Outcome as Determined by an Established Scale	Poor	13 percentage of participants
6 Month	Cosmetic Outcome as Determined by an Established Scale	Excellent	0 percentage of participants
6 Month	Cosmetic Outcome as Determined by an Established Scale	Good	25 percentage of participants
6 Month	Cosmetic Outcome as Determined by an Established Scale	Fair	75 percentage of participants
6 Month	Cosmetic Outcome as Determined by an Established Scale	Poor	0 percentage of participants
9 Months	Cosmetic Outcome as Determined by an Established Scale	Good	20 percentage of participants
9 Months	Cosmetic Outcome as Determined by an Established Scale	Poor	20 percentage of participants
9 Months	Cosmetic Outcome as Determined by an Established Scale	Fair	60 percentage of participants
9 Months	Cosmetic Outcome as Determined by an Established Scale	Excellent	0 percentage of participants
12 Months	Cosmetic Outcome as Determined by an Established Scale	Good	20 percentage of participants
12 Months	Cosmetic Outcome as Determined by an Established Scale	Poor	10 percentage of participants
12 Months	Cosmetic Outcome as Determined by an Established Scale	Fair	60 percentage of participants
12 Months	Cosmetic Outcome as Determined by an Established Scale	Excellent	10 percentage of participants
5 Years	Cosmetic Outcome as Determined by an Established Scale	Poor	17 percentage of participants
5 Years	Cosmetic Outcome as Determined by an Established Scale	Excellent	0 percentage of participants
5 Years	Cosmetic Outcome as Determined by an Established Scale	Good	33 percentage of participants
5 Years	Cosmetic Outcome as Determined by an Established Scale	Fair	50 percentage of participants

Primary

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.

Time frame: 3 months after RT