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

NCT04849871 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 202104085
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma; Breast Cancer; Stage 0 Breast Cancer; Stage I Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

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

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

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

Secondary Outcomes (14)

• Proportion of patients who are free of breast cancer in the regional lymph nodes

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

• Proportion of patients who are free of distant disease

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

• Proportion of patients who are alive

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

• Change in quality of life as measured by EORTC QLQ-C30

  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

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

  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

Study Arms (2)

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)

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.

Radiation: External Beam Accelerated Partial Breast Irradiation

Interventions

External Beam Accelerated Partial Breast Irradiation RADIATION

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

Also known as: APBI

Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions); Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Imran Zoberi, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 19, 2021
• Study Start: August 12, 2021
• Primary Completion (Estimated): August 6, 2029
• Study Completion (Estimated): August 6, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)