Breast CancerEarly Phase 1NCT00527293
Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
A Early Phase 1 study testing adjuvant therapy, 3-dimensional conformal radiation therapy and brachytherapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 4 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy… 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?
- adjuvant therapy, 3-dimensional conformal radiation therapy and brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2007to Feb 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer, including the following histologic subtypes:
- Invasive ductal carcinoma
- Medullary ductal carcinoma
- Papillary ductal carcinoma
- Colloid (mucinous) ductal carcinoma
- Tubular ductal carcinoma
- The following histologic subtypes are not allowed:
- Invasive lobular carcinoma
- Extensive lobular carcinoma in situ
- Ductal carcinoma in situ (DCIS)
- Nonepithelial breast malignancies, such as lymphoma or sarcoma
- No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
- Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
- Lesion ≤ 3 cm
- No more than 3 positive lymph nodes
- Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
- Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
- Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
- Unifocal breast cancer
- No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
- No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
- No skin involvement of disease
- No Paget's disease of the nipple
- No distant metastatic disease
- Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant or lactating
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
- No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
- No other malignancy within the past 5 years, except non-melanomatous skin cancer
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the breast
- No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
- Concurrent hormonal therapy allowed
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lake/University Ireland Cancer Center
Cleveland, Ohio, 44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, 44145
About this study
Official title: Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
Read the detailed description
OBJECTIVES:
- To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
- To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
- To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
- To evaluate wound healing and overall complication rate after partial breast irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.
After completion of study therapy, patients are followed periodically for up to 5 years.
- Conditions
- Breast Cancer
- Being tested
- adjuvant therapy, 3-dimensional conformal radiation therapy, brachytherapy
- Keywords
- stage I breast cancer, stage II breast cancer, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, tubular ductal breast carcinoma, papillary ductal breast carcinoma
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapyProcedure or surgery
If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
3-dimensional conformal radiation therapyRadiation
3-dimensional conformal radiotherapy twice daily for 5-10 days.
brachytherapyRadiation
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
| Study group | Role | What they receive |
|---|---|---|
| MammoSite Brachytherapy | Experimental | Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days Receives: Procedure: adjuvant therapy; Radiation: brachytherapy |
| 3-dimensional conformal radiotherapy | Experimental | 3-dimensional conformal radiotherapy twice daily for 5-10 days. Receives: Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
Measured: 1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire
Measured: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr
Wound healing and overall complication rate after partial breast irradiation
Measured: 1 month after RT & Q3mos for one year
Determination of which patients are best suited for each individual technique of partial breast irradiation
Measured: Patients will be followed for a period of five years following completion of radiation.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
Measured: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janice Lyons, MD, Study chair, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527293
- Sponsor's protocol ID
- CASE2104
- Other IDs
- P30CA043703, CASE2104
- Status last verified
- Aug 2015
- First submitted
- 7 Sep 2007
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT00527293
- Acronym / sponsor ID
- CASE2104
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, tubular ductal breast carcinoma, papillary ductal breast carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
Detailed description
OBJECTIVES:
- To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
- To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
- To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
- To evaluate wound healing and overall complication rate after partial breast irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.
After completion of study therapy, patients are followed periodically for up to 5 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MammoSite Brachytherapy | Experimental | Procedure: adjuvant therapy, Radiation: brachytherapyPatients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days |
| 3-dimensional conformal radiotherapy | Experimental | Procedure: adjuvant therapy, Radiation: 3-dimensional conformal radiation therapy3-dimensional conformal radiotherapy twice daily for 5-10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| adjuvant therapyIf chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation. | Procedure or surgery | 3-dimensional conformal radiotherapy, MammoSite Brachytherapy |
| 3-dimensional conformal radiation therapy3-dimensional conformal radiotherapy twice daily for 5-10 days. | Radiation | 3-dimensional conformal radiotherapy |
| brachytherapyPatients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days | Radiation | MammoSite Brachytherapy |
Primary outcome
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
Time frame: 1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire
Time frame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr
Wound healing and overall complication rate after partial breast irradiation
Time frame: 1 month after RT & Q3mos for one year
Determination of which patients are best suited for each individual technique of partial breast irradiation
Time frame: Patients will be followed for a period of five years following completion of radiation.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
Time frame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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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.
Janice Lyons, MD study chair
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing adjuvant therapy, 3-dimensional conformal radiation therapy and brachytherapy in people with Breast Cancer, run by Case Comprehensive Cancer Center at 4 sites 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?
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 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon (time frame: 1 month after RT & Q3mos for one year). The study lists 5 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 25 Aug 2015.