NCT07654257 Partial Breast Irradiation Breast Cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07654257—Single FrAction Interstitial BreaSt BracHytherApy (SASHA)—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07654257 is a hot trial to watch

Breast Cancer is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07654257 is notable because it evaluates Partial Breast Irradiation in a Phase 2 design while Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 134 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Primary: Incidence of accelerated partial breast irradiation (APBI) related toxicities of interest occurring at grade ≥3 at 1, 3, and 5 years after APBI. The descriptions and grading scales found in the The National Cancer Institutes' (NCI) Common Terminology Criteria for Adverse Events is a descriptive terminology (CTCAE), a list of standardized definitions for adverse events, revised v6.0 will be utilized for adverse (AE) (toxicity) reporting. (Baseline through 30 days following treatment, up to 5 years.)
• Secondary: Cosmetic results at 1, 3, and 5 years after APBI, as assessed by The Breast Cancer Treatment Outcome Scale (BCTOS-12), a shortened, validated patient-reported outcome measure designed to assess aesthetic and functional outcomes after breast-conserving surgery. This is scored on a scale of 1-4 ("no difference" to "large difference"), where lower scores indicate better outcomes of satisfaction (Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment)
• Secondary: The BREAST-Q radiation-specific module patient-reported outcome measure (PROM) that evaluates patient satisfaction with the cosmetic effects of radiation The Breast-Q is 6 questions and scored on a scale of 1-3 ("not at all" to "a lot") with lower scores indicating better outcomes of satisfaction. (Baseline, 6 months, 1 year, 3 years, up to 5 years following treatment)
• Secondary: The Harvard Cosmesis Scale is a physician-rated form will be used by the radiation oncologist to score cosmesis with the following criteria: * Excellent: treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. * Good: minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring. * Fair: significant radiation effects readily observable. * Poor: severe sequelae of breast tissue secondary to radiation effect. (Baseline, 6 months, then annually up to 5 years following treatment)
• Secondary: Digital photographs will be taken to visualize any potential changes in breast shape or contour. These will be taken by study staff utilizing the Radiation Oncology Department's designated camera. blindly analyzed by 2-3 radiation oncologists using the following 4-point numerical scale: * 4 (Excellent): the treated breast looks essentially the same as the contralateral breast as it relates to radiation effects. This includes patients with grade 1 punctate scarring. * 3 (Good): minimal but identifiable radiation effects of the treated breast. This includes patients with grade 2 punctate scarring. * 2 (Fair): significant radiation effects readily observable. * 1 (Poor): severe sequelae of breast tissue secondary to radiation effect. Photos will be uploaded to the digital study record. Analysis will be batched as study progresses. Each individual score as well as the average score will be entered into the electronic case report form (eCRF). (Baseline, 5 weeks, 6 months, annually up to 5 years following treatment)

Benchmark readouts in the surrounding field

• Netupitant/Palonosetron Hydrochloride and Dexamethasone With or Without Prochlorperazine or Olanzapine in Improving Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer (Phase 3): Cycle 1(Mean) = 4.51 units on a scale (Standard Error, 0.155); Cycle 1(Mean) = 4.93 units on a scale (Standard Error, 0.141)
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
• A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: Not reported

Company & Deal Intelligence context: Virginia Commonwealth University — United States — http://www.vcu.edu

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Sequencing evidence: comparative data after the most relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

NCT07654257 is a focused lens on Breast Cancer development. Its value will be determined by whether Partial Breast Irradiation can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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