Breast NeoplasmsNCT02076074
Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer
A study testing accelerated partial breast irradiation in people with Breast Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- accelerated partial breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2014to 18 May 2023
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. 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. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
- Negative histologic margins of partial mastectomy or re-excision specimen. 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.
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
- Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin for at least 4 weeks after completion of HG-PBI.
- Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
- Postmenopausal status.
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- Age ≥ 50 years at diagnosis.
- Able to understand and willing to sign IRB-approved written informed consent document.
- English speaker.
- -Women and members of all races and ethnic groups are eligible for this trial. Because breast cancer occurs rarely in men, men will not be recruited for participation.
Who cannot join
- Presence of distant metastases.
- In situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- 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.
- Premenopausal status.
- 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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- Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
- Diagnosis of psychiatric or addictive disorders that would preclude obtaining informed consent.
- History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Paget's disease of the nipple.
- Skin involvement, regardless of tumor size.
- Unsatisfactory breast for HG-PBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with HG-PBI is technically problematic.
- Partial mastectomy so extensive that the cosmetic result is fair or poor prior to HG-PBI as determined by the treating physician.
- Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
- Time between final definitive breast procedure to HG-PBI simulation is greater than 8 weeks.
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 Single Fraction High-Gradient Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-Risk Stage 0 and I Breast Carcinoma
This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.
Read the detailed description
This is a phase I/II study which will evaluate the complication rates, local control, cosmetic results, and quality of life of single fraction high gradient partial breast irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with pathologic stage 0 (=< 2 cm) or I carcinoma of the breast treated with partial mastectomy with histologically assessed negative surgical margins.
- Conditions
- Breast Neoplasms
- Being tested
- accelerated partial breast irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated partial breast irradiationRadiation
Also called APBI
Undergo HG-PBI
| Study group | Role | What they receive |
|---|---|---|
| Treatment (HG-PBI) | Experimental | Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. Receives: Radiation: accelerated partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Are Free of Serious Treatment Related Toxicity
Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Measured: Up to 5 years
Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast
Percentage of patients without ipsilateral breast tumor recurrences (IBTR).
Measured: At 5 years
Secondary outcomes (11)
Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes
Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups.
Measured: At 5 years
Percentage of Patients Who Are Free From Distant Metastases
Measured: At 5 years
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. For the global health and five functional scales (Cognitive Functioning, Emotional Functioning, Physical Functioning, Role Functioning, and Social Functioning) a high score correlates to a high level of functioning or a better outcome. For the three symptom scales and six single item scales (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea, Financial Difficulties) a high score correlates to high levels of symptoms or problems and a worse outcome.
Measured: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
The QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss.
All of the scales and single-item measures range in score from 0 to 100. For the four symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms, Breast Symptoms) a high score correlates to high levels of symptoms or problems and a worse outcome. For the four functional scales (Body Image, Future Perspective, Sexual Functioning, Sexual Enjoyment) a high score correlates to a high/healthy level of functioning or a better outcome
Measured: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor (0) and "severe pain" at (10) with the patient's mark providing a range of scores from 0-100 millimeters. A higher score indicates greater pain intensity.
Measured: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA)
This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features.
Measured: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA)
This instrument includes a formula expressing the extent of displacement of the treated breast relative to the contralateral breast and other anatomical features. This is calculated from dividing the BRA score by the reference length from sternal notch to contralateral nipple and then multiplying that value by 100 to get a percentage.
Measured: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale.
Using this scale, cosmesis is qualitatively evaluated by the treating radiation oncologist by comparing the treated breast with the contralateral breast using the Aronson Modified Scale. The global cosmetic result, appearance of the surgical scar, breast size, breast shape, skin color, location of the areola and nipple, and shape of the areola and nipple were scored on a 4-point scale. In this case 1 is 'excellent' with 4 being 'poor.'
Measured: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Number of Patients With Complications Using CTCAE v. 4.0
Acute complications are defined as complications that occurred from start of treatment until day 90. Late complications are defined as complications that occurred from Day 91 until completion of 5 year follow-up.
Measured: Up to 5 years
Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0
Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Measured: Up to 5 years
Percentage of Patients Undergoing Mastectomy on the Treated Side
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start2 Apr 2014
- Primary completion18 May 2023
- Study completion18 May 2023
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 NeoplasmsStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Zoberi, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076074
- Sponsor's protocol ID
- 201401160
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2014
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Single Fraction High-Gradient Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-Risk Stage 0 and I Breast Carcinoma
- ClinicalTrials.gov ID
- NCT02076074
- Acronym / sponsor ID
- 201401160
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 2 Apr 2014 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.
Detailed description
This is a phase I/II study which will evaluate the complication rates, local control, cosmetic results, and quality of life of single fraction high gradient partial breast irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with pathologic stage 0 (=< 2 cm) or I carcinoma of the breast treated with partial mastectomy with histologically assessed negative surgical margins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (HG-PBI) | Experimental | Radiation: accelerated partial breast irradiationPatients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. 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. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
- Negative histologic margins of partial mastectomy or re-excision specimen. 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.
- Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
- Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin for at least 4 weeks after completion of HG-PBI.
- Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
Key exclusion criteria (16 listed)
- Presence of distant metastases.
- In situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
- 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.
- Premenopausal status.
- 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 |
|---|---|---|
| accelerated partial breast irradiationAlso: APBIUndergo HG-PBI | Radiation | Treatment (HG-PBI) |
Primary outcome
Percentage of Patients Who Are Free of Serious Treatment Related Toxicity
Time frame: Up to 5 years
Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.
Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast
Time frame: At 5 years
Percentage of patients without ipsilateral breast tumor recurrences (IBTR).
11 secondary outcomes
Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes
Time frame: At 5 years
Percentage of Patients Who Are Free From Distant Metastases
Time frame: At 5 years
Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30
Time frame: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23
Time frame: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain
Time frame: 2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5
Cosmesis as Measured by the Mean Change From Baseline - Breast Retraction Assessment (BRA)
Time frame: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Cosmesis as Measured by the Mean Change From Baseline - Percentage Breast Retraction Assessment (pBRA)
Time frame: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Cosmesis as Measured by the Mean Change From Baseline - Aronson Modified Harris Scale.
Time frame: 8 weeks, 6 months, 12 months, 24 months, 36 months, year 4, and year 5
Number of Patients With Complications Using CTCAE v. 4.0
Time frame: Up to 5 years
Number of Participants With Grade 3-4 Toxicities Using CTCAE v4.0
Time frame: Up to 5 years
Percentage of Patients Undergoing Mastectomy on the Treated Side
Time frame: At 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- 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.
- Individual participant dataSharing planned: No
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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, M.D. 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 accelerated partial breast irradiation in people with Breast Neoplasms, 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 10 inclusion and 16 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 11 Jul 2024. 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 11 Jul 2024). 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?
Percentage of Patients Who Are Free of Serious Treatment Related Toxicity (time frame: Up to 5 years). The study lists 2 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 11 Jul 2024.