Breast CancerNCT00599989
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
A study testing adjuvant therapy, conventional surgery and 3-dimensional conformal radiation therapy in people with Breast Cancer and Long-term Effects Secondary to Cancer Therapy in Adults, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Skin Reactions Secondary to Radiation Therapy
- What is being tested?
- adjuvant therapy, conventional surgery and 3-dimensional conformal radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to 11 May 2009
- Phase
- Interventional
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Women who have chosen to undergo breast conservation therapy, including lumpectomy and breast irradiation, at the University of Pennsylvania for any invasive mammary carcinoma or intraductal breast cancer
- Stage I-II invasive or intraductal breast cancer
- Unifocal tumor ≤ 3.0 cm in size
- Patients with microscopic multifocality are eligible provided total pathologic tumor size is ≤ 3 cm
- No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters
- Pre- or post-biopsy ipsilateral* breast MRI negative for multicentric disease (i.e., areas of cancer that cannot be removed in a single excision specimen) or other suspicious findings NOTE: *Patients with synchronous bilateral breast cancers who will be treated with radiotherapy to each breast are eligible, provided such treatment can be performed in a manner that avoids overlap between treatment fields. Both sides may be treated with partial breast irradiation (PBI) if the pathologic eligibility criteria are met for both tumors, or only one side may be treated with PBI if the criteria are met for only one tumor.
- Negative margins of excision (≥ 2 mm) OR no tumor seen in a re-excision specimen
- No extensive intraductal component present
- Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed)
- If a SLN is positive on hematoxylin and eosin (but not by immunohistochemistry alone), complete axillary lymph node dissection is required
- Axillary lymph node staging is not required for patients with ductal carcinoma in situ
- No SLN identified in the internal mammary nodes
- No node > 2 cm
- No node with extracapsular extension
- Surgical clips placed in the operative bed OR ability to visualize operative bed on CT scan of the breast
- Target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on the treatment planning CT scan
- No diffuse calcifications on diagnostic mammogram
- Negative post-biopsy mammogram required if presented with mammographically detected microcalcifications
- Hormone receptor status unspecified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- History of non-breast malignancies allowed provided patients have been disease free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence
- Treated carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, or basal cell and squamous cell skin cancer within the past 5 years allowed
- Patients must agree to undergo breast MRI
- No contraindication to MRI, including a pacemaker or other foreign body
- Not pregnant or nursing
- No technical impediment to appropriate dosimetry
- No personal history of collagen vascular disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior in-field irradiation
- No presence of breast implant
- No breast reconstructive surgery prior to study entry
- No prior neoadjuvant chemotherapy or hormonal therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: Accelerated Partial Breast Irradiation
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
Read the detailed description
OBJECTIVES:
- To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
- To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
- To summarize the institutional experience of these patients treated with this experimental therapy.
OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).
After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
- Conditions
- Breast Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Skin Reactions Secondary to Radiation Therapy
- Being tested
- adjuvant therapy, conventional surgery, 3-dimensional conformal radiation therapy, brachytherapy, intracavitary balloon brachytherapy
- Keywords
- long-term effects secondary to cancer therapy in adults, skin reactions secondary to radiation therapy, stage I breast cancer, stage II breast cancer, invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, comedo ductal breast carcinoma, ductal breast carcinoma in situ, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, Paget disease of the breast with intraductal carcinoma, Paget disease of the breast with invasive ductal carcinoma, breast cancer in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Lobular, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
3-dimensional conformal radiation therapyRadiation
brachytherapyRadiation
intracavitary balloon brachytherapyRadiation
proton beam radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| APBI | Experimental | Not described Receives: Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: 3-dimensional conformal radiation therapy; Radiation: brachytherapy; Radiation: intracavitary balloon brachytherapy; Radiation: proton beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
Measured: 11 months
Secondary outcomes (4)
Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up
Measured: 11 months
Site of disease recurrence (i.e., local, regional, or distant)
Measured: 11 months
Time to recurrence
Measured: 11 months
Time to locoregional recurrence
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2005
- Primary completion11 May 2009
- Study completion11 May 2009
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 Abramson Cancer Center at Penn 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lilie Lin, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599989
- Sponsor's protocol ID
- CDR0000581427
- Other IDs
- UPCC-08104, UPCC-IRB-801897
- Status last verified
- Apr 2019
- First submitted
- 11 Jan 2008
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Partial Breast Irradiation
- ClinicalTrials.gov ID
- NCT00599989
- Acronym / sponsor ID
- CDR0000581427
- Conditions
- Breast Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Skin Reactions Secondary to Radiation Therapy
- Keywords
- long-term effects secondary to cancer therapy in adults, skin reactions secondary to radiation therapy, stage I breast cancer, stage II breast cancer, invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, comedo ductal breast carcinoma, ductal breast carcinoma in situ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2005
- Primary completion
- 11 May 2009 (actual)
- Study completion
- 11 May 2009 (actual)
- First posted
- 24 Jan 2008 (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 to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
Detailed description
OBJECTIVES:
- To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
- To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
- To summarize the institutional experience of these patients treated with this experimental therapy.
OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).
After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APBI | Experimental | Procedure: adjuvant therapy, Procedure: conventional surgery, Radiation: 3-dimensional conformal radiation therapy, Radiation: brachytherapy, Radiation: intracavitary balloon brachytherapy, Radiation: proton beam radiation therapy |
Who may qualify
- Ages
- 18 to 120 years
- 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 therapy | Procedure or surgery | APBI |
| conventional surgery | Procedure or surgery | APBI |
| 3-dimensional conformal radiation therapy | Radiation | APBI |
| brachytherapy | Radiation | APBI |
| intracavitary balloon brachytherapy | Radiation | APBI |
| proton beam radiation therapy | Radiation | APBI |
Primary outcome
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy
Time frame: 11 months
4 secondary outcomes
Late toxicity and cosmesis as assessed at or before 3 years from the start of radiotherapy and every 3 months during follow-up
Time frame: 11 months
Site of disease recurrence (i.e., local, regional, or distant)
Time frame: 11 months
Time to recurrence
Time frame: 11 months
Time to locoregional recurrence
Time frame: 11 months
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 9 Apr 2020.
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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.
Lilie Lin, MD principal investigator
Abramson Cancer Center at Penn 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 adjuvant therapy, conventional surgery and 3-dimensional conformal radiation therapy in people with Breast Cancer and Long-term Effects Secondary to Cancer Therapy in Adults, run by Abramson Cancer Center at Penn 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?
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 9 Apr 2020. 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?
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?
Acute toxicity as assessed by NCI CTC at 1 week, 4 weeks, and 3 months after completion of study therapy (time frame: 11 months). 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 9 Apr 2020.