Breast CancerNCT00593346
Evaluation of Accelerated Partial Breast Brachytherapy
A study testing brachytherapy in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 < 2 years.
- Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or completing the full series of high dose rate brachytherapy treatments on an outpatient basis.
- Patients with Paget's disease of the nipple.
- Patients with skin involvement, regardless of tumor size.
- Patients with a breast unsatisfactory for brachytherapy. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, placement of catheters is technically problematic.
- Patients with tylectomies so extensive that the cosmetic result is fair or poor prior to brachytherapy.
- Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
- Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma.
- Other malignancy, except non-melanoma skin cancer, ≤ 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous.
- Time between final definitive breast procedure to radioactive source loading of the brachytherapy catheters is greater than 8 weeks.
- Patients with diffuse (> 1 quadrant or >5 cm in diameter) suspicious microcalcifications.
- Patients with suspicious microcalcifications remaining on the post-tylectomy mammogram
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Carcinoma
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
Read the detailed description
This study will evaluate the local control, cosmetic results, quality of life, and complication rates of brachytherapy when used as the sole method of radiation therapy for patients with stage 0,I, and II carcinoma of the breast treated with tylectomy, with histologically assessed negative surgical margins, N0 axillary nodes.
- Conditions
- Breast Cancer
- Being tested
- brachytherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
brachytherapy (radioactive implants)
| Study group | Role | What they receive |
|---|---|---|
| Accelerated partial breast brachytherapy | Experimental | Each patient will receive accelerated partial breast brachytherapy with multiple plane implant. Receives: Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Using Ipsilateral Breast Tumor Recurrence Rates
Measured: 2 years after treatment completion
Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates
Measured: 5 years after treatment completion
Local Control Using Disease-free Survival Rates
Measured: 2 years after treatment completion
Local Control Using Disease-free Survival Rates
Measured: 5 years after treatment completion
Secondary outcomes (8)
Quality of Life Completion
-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.
Measured: 2 years
Excellent-good Cosmetic Outcomes - Patient Reported
- Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.
- The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).
Measured: 3 years after completion of therapy
Excellent-good Cosmetic Outcomes - Physician Reported
- Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).
- The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference).
Measured: 3 years after completion of therapy
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported
-Patients filled out a form "Patient Evaluation of the Treated Breast". On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to:
- caused mostly by radiation
- caused by both the radiation and surgery, but mostly by the radiation
- caused by both the radiation and surgery, but mostly by the surgery
- caused mostly by the surgery
- can't judge which treatment caused the change
- there are no changes
Measured: 3 years
Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)
-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)
Measured: Pre-treatment and 3 years
Presence or Absence of Complications
As defined by number of participants who experienced breast infection and symptomatic fat necrosis.
Measured: 5 years after treatment completion
Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment
Measured: 5 years after treatment completion
Frequency of Grade 3-4 Toxicities
RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.
Measured: Up to 1 year from completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMar 2004
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Zoberi, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593346
- Sponsor's protocol ID
- 03-1205 / 201011816
- Status last verified
- Jun 2015
- First submitted
- 2 Jan 2008
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accelerated Partial Breast Brachytherapy as the Sole Method of Radiation Therapy for Stage 0, 1 and II Lymph Node Negative Breast Carcinoma
- ClinicalTrials.gov ID
- NCT00593346
- Acronym / sponsor ID
- 03-1205 / 201011816
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will evaluate the local control, cosmetic results, quality of life, and complication rates of brachytherapy when used as the sole method of radiation therapy for patients with stage 0,I, and II carcinoma of the breast treated with tylectomy, with histologically assessed negative surgical margins, N0 axillary nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated partial breast brachytherapy | Experimental | Radiation: brachytherapyEach patient will receive accelerated partial breast brachytherapy with multiple plane implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brachytherapybrachytherapy (radioactive implants) | Radiation | Accelerated partial breast brachytherapy |
Primary outcome
Local Control Using Ipsilateral Breast Tumor Recurrence Rates
Time frame: 2 years after treatment completion
Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates
Time frame: 5 years after treatment completion
Local Control Using Disease-free Survival Rates
Time frame: 2 years after treatment completion
Local Control Using Disease-free Survival Rates
Time frame: 5 years after treatment completion
8 secondary outcomes
Quality of Life Completion
Time frame: 2 years
Excellent-good Cosmetic Outcomes - Patient Reported
Time frame: 3 years after completion of therapy
Excellent-good Cosmetic Outcomes - Physician Reported
Time frame: 3 years after completion of therapy
Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported
Time frame: 3 years
Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)
Time frame: Pre-treatment and 3 years
Presence or Absence of Complications
Time frame: 5 years after treatment completion
Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment
Time frame: 5 years after treatment completion
Frequency of Grade 3-4 Toxicities
Time frame: Up to 1 year from completion of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Zoberi, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brachytherapy in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control Using Ipsilateral Breast Tumor Recurrence Rates (time frame: 2 years after treatment completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.