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NCT Number: NCT00945061

Radiation Therapy in Treating Patients With Recurrent Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHHS Chagrin Highlands Medical Center, Cleveland, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intracavitary balloon brachytherapy

Radiation

Patients undergo brachytherapy

intraoperative radiation therapy

Radiation

Patients undergo radiotherapy

Primary outcomes

  1. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 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.

  2. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 3 months after 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.

  3. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 6 months after 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.

  4. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 9 months after 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.

  5. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 12 months after 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.

  6. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 2 years after 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.

  7. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 3 years after 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.

  8. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 4 years after 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.

  9. Ipsilateral Breast Tumor Recurrence Rates

    Time frame: 5 years after 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.

  10. Tumor Bed Recurrence Rates

    Time frame: 1 month after RT

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

  11. Tumor Bed Recurrence Rates

    Time frame: 3 month after RT

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

  12. Tumor Bed Recurrence Rates

    Time frame: 6 month after RT

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

  13. Tumor Bed Recurrence Rates

    Time frame: 12 month after RT

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

  14. Tumor Bed Recurrence Rates

    Time frame: 2 years after RT

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

  15. Tumor Bed Recurrence Rates

    Time frame: 3 years after RT

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

  16. Tumor Bed Recurrence Rates

    Time frame: 4 years after RT

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

  17. Tumor Bed Recurrence Rates

    Time frame: 5 years after RT

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

  18. Cosmetic Outcome as Determined by an Established Scale

    Time frame: 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

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

    Time frame: 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"

    • 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.

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

    Time frame: 3 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"

    • 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.

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

    Time frame: 6 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"

    • 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.

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

    Time frame: 9 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"

    • 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.

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

    Time frame: 12 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"

    • 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.

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

    Time frame: 2 years 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"

    • 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.

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

    Time frame: 3 years 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"

    • 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.

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

    Time frame: 4 years 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"

    • 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.

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

    Time frame: 5 years 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"

    • 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.

  28. Percent of Participants Experiencing Complications After Intervention

    Time frame: 1 month after RT

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

  29. Percent of Participants Experiencing Complications After Intervention

    Time frame: 3 month after RT

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

  30. Percent of Participants Experiencing Complications After Intervention

    Time frame: 6 month after RT

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

  31. Percent of Participants Experiencing Complications After Intervention

    Time frame: 9 month after RT

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

  32. Percent of Participants Experiencing Complications After Intervention

    Time frame: 12 month after RT

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

  33. Percent of Participants Experiencing Complications After Intervention

    Time frame: 2 years after RT

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

  34. Percent of Participants Experiencing Complications After Intervention

    Time frame: 3 years after RT

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

  35. Percent of Participants Experiencing Complications After Intervention

    Time frame: 4 years after RT

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

  36. Percent of Participants Experiencing Complications After Intervention

    Time frame: 5 years after RT

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

Secondary outcomes

  1. Percent of Participants With Delayed Wound Healing

    Time frame: 1 month after RT

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

  2. Percent of Participants With Delayed Wound Healing

    Time frame: 3 month after RT

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

  3. Percent of Participants With Delayed Wound Healing

    Time frame: 6 month after RT

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

  4. Percent of Participants With Delayed Wound Healing

    Time frame: 9 month after RT

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

  5. Percent of Participants With Delayed Wound Healing

    Time frame: 12 month after RT

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

  6. Percent of Participants With Delayed Wound Healing

    Time frame: 2 years after RT

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

  7. Percent of Participants With Delayed Wound Healing

    Time frame: 3 years after RT

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

  8. Percent of Participants With Delayed Wound Healing

    Time frame: 4 years after RT

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

  9. Percent of Participants With Delayed Wound Healing

    Time frame: 5 years after RT

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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2009
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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