N/A
N=151
Evaluation of Accelerated Partial Breast Brachytherapy
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00593346 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Local Control Using Ipsilateral Breast Tumor Recurrence Rates — .7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- brachytherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Control Using Ipsilateral Breast Tumor Recurrence Rates |
.7 | — |
| PRIMARY Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates |
3.4 | — |
| PRIMARY Local Control Using Disease-free Survival Rates |
94.4 | — |
| PRIMARY Local Control Using Disease-free Survival Rates |
94.4 | — |
| SECONDARY Quality of Life Completion |
99; 95; 91; 88; 74 | — |
| SECONDARY Excellent-good Cosmetic Outcomes - Patient Reported |
92; 91; 87; 92 | — |
| SECONDARY Excellent-good Cosmetic Outcomes - Physician Reported |
97; 97; 94; 94 | — |
| SECONDARY Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported |
16.5; 57; 19; 7.5 | — |
| SECONDARY Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA) |
7.35; 7.64 | — |
| SECONDARY Presence or Absence of Complications |
6; 19 | — |
| SECONDARY Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment |
4 | — |
| SECONDARY Frequency of Grade 3-4 Toxicities |
1; 2; 0; 0; 0; 0 | — |
Summary
Over the past two decades, breast conserving therapy (BCT) has become a major treatment modality for Stage I and II breast carcinoma. The major advantages of breast conserving therapy are superior cosmetic outcome and the reduced emotional and psychological trauma afforded by this procedure compared with conventional mastectomy. The principal disadvantage of BCT is its more complex and prolonged treatment regimen requiring approximately 6 weeks of external beam radiation therapy that poses problems for some patients such as the working woman, elderly patients, and those who live at a significant distance from a treatment center. These factors, along with the patient's geographic location, result in a smaller fraction of the patients who currently meet eligibility criteria for BCT actually receiving it, despite its cosmetic and probable psychological advantages. The logistical problems of BCT are primarily related to the protracted course of external beam radiation therapy to the whole breast. While some investigators reported what they believe to be acceptable local control rates in carefully selected patients treated by wide local excision without radiation therapy, the criteria for patient selection are controversial and poorly defined and probably restrict the access of many patients to breast conserving therapy.
If previous observations are valid and breast irradiation following tylectomy exerts its maximal effect in eradicating occult disease remaining in the immediate vicinity of the tylectomy site, can radiation therapy be directed only to the tissue surrounding the excision cavity of the breast, using brachytherapy alone? If so, the entire course of radiation therapy could be delivered over a 4 to 7 day period immediately following tylectomy and/or axillary dissection, thus markedly reducing treatment time. Brachytherapy also inherently provides a higher central dose to the volume most at risk for recurrence. Cosmetic outcome after the use of a brachytherapy boost after external whole breast radiotherapy is comparable or slightly inferior to electron beam boost radiation therapy
Eligibility Criteria
Inclusion Criteria
- AJCC stage 0, I, or II (TisN0, T1N0, T2N0 = 3 cm) histologically confirmed carcinoma of the breast, treated with tylectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate.
- Signed study-specific informed consent for participation in the study.
- Negative, or close but negative, inked histologic margins of tylectomy or reexcision specimen to be confirmed prior to placing the brachytherapy catheters. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.
- Negative post-tylectomy or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy.
- For patients with invasive cancer, no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous),or tubular histologies. Noninvasive ductal carcinoma in situ.
- Chemotherapy or hormonal therapy planned for = 2 weeks after removal of brachytherapy catheters is permitted. Hormonal therapy is allowed during brachytherapy at treating radiation oncologist's decision.
- Negative pregnancy test for premenopausal patients with an intact uterus
Exclusion Criteria
- Patients with distant metastases.
- Patients with in-situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- Patients with proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Patients who are pregnant or lactating.
- Patients with histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
- Patients with systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash.
- Patients with coexisting medical conditions in whom life expectancy is 1 quadrant or >5 cm in diameter) suspicious microcalcifications.
- Patients with suspicious microcalcifications remaining on the post-tylectomy mammogram
Data sourced from ClinicalTrials.gov (NCT00593346). 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.