N/A
N=13
Radiation Therapy in Treating Patients With Recurrent Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00945061 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Ipsilateral Breast Tumor Recurrence Rates — 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intracavitary balloon brachytherapy (Radiation); intraoperative radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Ipsilateral Breast Tumor Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Tumor Bed Recurrence Rates |
11; 0 | — |
| PRIMARY Cosmetic Outcome as Determined by an Established Scale |
8; 0; 13; 0; 0; 10 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey |
100 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| PRIMARY Percent of Participants Experiencing Complications After Intervention |
40; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
| SECONDARY Percent of Participants With Delayed Wound Healing |
10; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00945061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.