Single FrAction Interstitial BreaSt BracHytherApy

Official title

Single FrAction Interstitial BreaSt BracHytherApy (SASHA)

Overview

This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.

Interventions

• Drug Partial Breast Irradiation
  16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day

Primary outcome measures

• Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) [Time frame: Baseline through 30 days following treatment, up to 5 years.]

Secondary outcome measures (6)

• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the Breast Cancer Treatment Outcome Scale (BCTOS-12) [Time frame: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment]
• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI utilizing the breast cancer core checklist (postoperative) (BREAST-Q) [Time frame: Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment]
• Assess the rate of excellent or good cosmesis after a 1-day course of APBI utilizing the Harvard Cosmesis Scale [Time frame: Baseline, 6 months, then annually up to 5 years following treatment]
• Assess the rate of excellent or good cosmesis at 1, 3, and 5 years after a 1-day course of APBI assessed by Digital Photographs [Time frame: Baseline, 5 weeks, 6 months, annually up to 5 years following treatment]
• Assess cumulative treatment-related breast toxicities for up to 5 years after a 1-day course of accelerated partial breast irradiation (APBI) [Time frame: Baseline, up to 5 years following treatment]
• Determine the percentage of patients who remain free of local disease progression (e.g., tumor recurrence or local spread) of breast cancer when treated with a 1-day course of APBI [Time frame: 1 year, 3 years, and up to 5 years following treatment]

Eligibility criteria

Inclusion criteria

• Female
• New diagnosis of Ductal Carcinoma in Situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
• Age 40-85 at diagnosis
• Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist
• T stage of Tis, T1, or T2
• T2 tumors must be ≤3 cm in maximum diameter
• If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy
• For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node(s) must be pathologically negative Note: N0(i+) is not an exclusion criterion

Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:

• ≥70 years of age
• Estrogen receptor (ER)+, progesterone receptor (PR)+/-, HER2-
• Grade 1-2 breast cancer
• Tumor ≤2 cm in size

Note: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:

• 50-69 years of age
• Grade 1-2 breast cancer
• Clinically negative axilla by ultrasound and/or magnetic resonance imaging (MRI)
• ER+, PR+, HER2-
• Tumor ≤2 cm in size
• Agrees to comply with aromatase inhibitor recommendation
• Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Pregnant or breastfeeding
• Active collagen-vascular disease
• Paget's disease of the breast
• Any prior history of DCIS or invasive breast cancer prior to the current diagnosis
• Any prior history of breast radiation therapy (RT) or thoracic RT for any condition
• Multicentric carcinoma (DCIS or invasive)
• Synchronous bilateral invasive or non-invasive breast cancer
• Surgical margins that cannot be microscopically assessed or that are positive
• Treatment with neoadjuvant chemotherapy
• Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT07654257 · MCC-25-22764 · HM300001026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗