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Breast CarcinomaBreaStBRTNCT04849871

Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma

A study testing External Beam Accelerated Partial Breast Irradiation in people with Breast Carcinoma and Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy. Read more about this study

Who is it for?
Ages 50 years and older, women only
What is being tested?
External Beam Accelerated Partial Breast Irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteUnited States
Study dates
12 Aug 2021to 6 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.
  • Negative histologic margins of partial mastectomy or re-excision specimen. The posterior margin is always considered widely negative if the partial mastectomy extended to the pectoralis fascia and there is no tumor on ink. 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.[42]
  • Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive.
  • Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of APBI.
  • 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.
  • All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with the following stipulations: F_APBI may be delivered at any Siteman location. S_APBI treatment must occur at the main Siteman location at BJH and will be delivered on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit. Pre and post treatment care is allowed at any Siteman center.

Who cannot join

  • Presence of distant metastases.
  • 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.
  • 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.
  • Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
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  • Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
  • Paget's disease of the nipple.
  • Skin involvement, regardless of tumor size.
  • Unsatisfactory breast for APBI 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 APBI is technically problematic.
  • Partial mastectomy so extensive that the cosmetic result is fair or poor prior to APBI as determined by the treating physician.
  • Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
  • Time between final definitive breast surgical procedures to APBI 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

Other trials in United States

About this study

Official title: Evaluation of Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma - BreaStBRT

This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy.

Being tested
External Beam Accelerated Partial Breast Irradiation
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Beam Accelerated Partial Breast IrradiationRadiation

    Also called APBI

    APBI simulation must take place no more than 8 weeks from final definitive breast surgery.

Study groups in NCT04849871
Study groupRoleWhat they receive
Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)Experimental-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)
Receives: Radiation: External Beam Accelerated Partial Breast Irradiation
Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)Experimental-External Beam APBI 30 Gy in 5 fractions over 5 days.
Receives: Radiation: External Beam Accelerated Partial Breast Irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who are free of breast cancer in the treated breast (IBTR)

    -IBTRs will be categorized as local (infield) if they occur within the prescription isodose volume, peripheral if between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume, and non-contiguous or extrafield if they are beyond the peripheral volume described above.

    Measured: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)

  2. Feasibility of treatment regimen as measured by the ability to complete accrual to the trial in 3 years

    Measured: Through enrollment of all participants (estimated to be 3 years)

Secondary outcomes (14)
  1. Proportion of patients who are free of breast cancer in the regional lymph nodes

    -Regional lymph nodes are ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups.

    Measured: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)

  2. Proportion of patients who are free of distant disease

    Measured: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)

  3. Proportion of patients who are alive

    Measured: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)

  4. Change in quality of life as measured by EORTC QLQ-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.
    • All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: Baseline, 6 months post-end of radiation therapy (RT), 12 months post-end of RT, 24 months post-end of RT, 36 months post-end of RT, 4 years post-end of RT, and 5 years post-end of RT

  5. Change in quality of life as measured by EORTC QLQ-BR23

    • The QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.
    • All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: Baseline, 6 months post-end of radiation therapy (RT), 12 months post-end of RT, 24 months post-end of RT, 36 months post-end of RT, 4 years post-end of RT, and 5 years post-end of RT

  6. Change in cosmesis as measured quantitatively by the Breast Retraction Assessment (BRA)

    -Breast Retraction Assessment (BRA) is an objective evaluation of the amount of cosmetic retraction of the treated breast in comparison to the untreated breast in patients. A clear acrylic sheet supported vertically and marked as a grid at 1 cm intervals is employed to perform the measurements.

    Measured: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years)

  7. Change in cosmesis as measured quantitatively by the Percent Breast Retraction Assessment (pBRA)

    -Breast Retraction Assessment (BRA) is an objective evaluation of the amount of cosmetic retraction of the treated breast in comparison to the untreated breast in patients. A clear acrylic sheet supported vertically and marked as a grid at 1 cm intervals is employed to perform the measurements.

    Measured: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years

  8. Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (physician graded)

    -The following general descriptors will be used:

    • Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.
    • Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
    • Fair - there is obvious difference in the size and shape of the treated breast. This change involves ¼ or less of the breast.
    • Poor - marked change in the appearance of the treated breast involving more than ¼ of the breast tissue.

    Measured: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years

  9. Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (patient graded)

    -The following general descriptors will be used:

    • Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.
    • Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
    • Fair - there is obvious difference in the size and shape of the treated breast. This change involves ¼ or less of the breast.
    • Poor - marked change in the appearance of the treated breast involving more than ¼ of the breast tissue.

    Measured: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years

  10. Presence of complications

    Measured: From start of treatment through 5 years (estimated to be 5 years and 5 days)

  11. Occurrence of mastectomy after completion of initial breast-conserving treatment

    Measured: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)

  12. Frequency of any CTCAE v5.0 grade 3-4 toxicities

    Measured: From start of treatment through 5 years (estimated to be 5 years and 5 days)

  13. Proportion of patients who are free of acute serious treatment related toxicity

    • Serious treatment related toxicity are those treatment-related grade 3 or higher adverse events as measured by CTCAE v5.0
    • 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, coronary artery disease, and pericarditis.

    Measured: From start of treatment until 6 months post-treatment (estimated to be 6 months)

  14. Proportion of patients who are free of late serious treatment related toxicity

    • Serious treatment related toxicity are those treatment-related grade 3 or higher adverse events as measured by CTCAE v5.0
    • 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, coronary artery disease, and pericarditis.

    Measured: From 6 months through 5 years (estimated to be 4.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start12 Aug 2021
  3. Primary completion6 Aug 2029 (estimated)
  4. Study completion6 Aug 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849871
Sponsor's protocol ID
202104085
Acronym
BreaStBRT
Status last verified
May 2026
First submitted
16 Apr 2021
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing External Beam Accelerated Partial Breast Irradiation in people with Breast Carcinoma and 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 9 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of patients who are free of breast cancer in the treated breast (IBTR) (time frame: Through 5 years after completion of treatment (estimated to be 5 years and 5 days)). 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 6 May 2026.

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