Radiation Therapy in Treating Patients With Recurrent Breast Cancer

NCT00945061 | Completed Results DMC FDA Device

• 1 other identifier: CASE11107
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (36)

• 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" 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.

  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" 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.

  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" 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.

  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" 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.

  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" 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.

  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" 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.

  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" 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.

  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" 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.

  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" 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.

  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 Outcomes (9)

• Percent of Participants With Delayed Wound Healing

  1 month after RT

• Percent of Participants With Delayed Wound Healing

  3 month after RT

• Percent of Participants With Delayed Wound Healing

  6 month after RT

• Percent of Participants With Delayed Wound Healing

  9 month after RT

• Percent of Participants With Delayed Wound Healing

  12 month after RT

Study Arms (2)

Intraoperative radiation therapy

EXPERIMENTAL

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

Radiation: intraoperative radiation therapy

Intracavitary balloon brachytherapy

EXPERIMENTAL

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

Radiation: intracavitary balloon brachytherapy

Interventions

intracavitary balloon brachytherapy RADIATION

Patients undergo brachytherapy

Intracavitary balloon brachytherapy

intraoperative radiation therapy RADIATION

Patients undergo radiotherapy

Intraoperative radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (3)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal

Results Point of Contact

• Title: Dr. Janice A. Lyons, MD
• Organization: University Hospitals Cleveland Medical Center , Case Comprehensive Cancer Center

Janice.Lyons@uhhospitals.org

+1 216-844-2536

Study Officials

• Janice Lyons, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: September 23, 2008
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

US (3)