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SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers

Single-Dose Stereotactic Radiosurgery (SDRT) as Definitive Non-Operative Treatment for Early-Stage Breast Cancer: A Prospective Single-Arm Pilot Trial With Bayesian Safety Monitoring (SOLIS / Protocol RAD 2024)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Secondary endpoints include biopsy-confirmed absence of residual invasive carcinoma at 12 months, imaging response on multiparametric MRI and FDG PET/CT, late toxicity, cosmesis, patient-reported outcomes, salvage surgery, and disease control through 36 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests one dose of focused radiation for small, early-stage breast cancers, without surgery to remove the lump. It is for adults age 50 or older whose cancer grows in response to estrogen and is HER2-negative, with extra limits for those under 65. The study mainly checks skin side effects and also tracks whether cancer remains or returns.

SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target volume) delivered with a cleared linear accelerator as definitive non-operative local treatment for early-stage, hormone receptor-positive, HER2-negative breast cancer with planned omission of lumpectomy. Adjuvant endocrine therapy is prescribed on-label. The primary endpoint is the incidence of CTCAE v5.0 Grade ≥2 skin adverse events within 90 days of treatment, monitored with a pre-specified Bayesian safety stopping rule. Secondary endpoints include biopsy-confirmed absence of residual invasive carcinoma at 12 months, imaging response on multiparametric MRI and FDG PET/CT, late toxicity, cosmesis, patient-reported outcomes, salvage surgery, and disease control through 36 months.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A needle biopsy shows invasive ductal cancer (cancer that starts in milk ducts) or another allowed cancer type.
  • One tumor, no larger than 2 cm, with no signs of cancer in nearby lymph nodes.
  • Cancer is estrogen receptor-positive, HER2-negative, and grade 1 or 2 (lower or medium grade).
  • Age 65 or older; or age 50–64 if surgery is not suitable or is declined. Only 10 of 30 people may be in the younger group.
  • The tumor is at least 5 mm from the skin and chest muscle.
  • Willing to take hormone-blocking medicine after radiation.
  • Able to care for yourself and be out of bed for at least half of waking hours.
  • Able to have MRI and FDG PET/CT scans and give informed consent.

Who can't join

  • More than one tumor area; only DCIS (cancer contained in milk ducts); or more than 10% invasive lobular cancer (cancer from milk-making glands).
  • A large amount of cancer within milk ducts, or calcium deposits spread widely through the breast.
  • Grade 3 (high-grade), triple-negative, or HER2-positive cancer; or cancer spread to lymph nodes or distant body parts.
  • Past radiation to the same breast, surgery to remove the lump or tissue for diagnosis, or chemotherapy before the planned treatment.
  • Tumor less than 5 mm from the skin or chest muscle; radiation safety limits cannot be met; or the planned radiation area is larger than 60 cubic cm.
  • Connective tissue disease, which affects tissues that support the body; another cancer not allowed by the study; pregnancy; or breastfeeding.
  • A harmful change in the BRCA1, BRCA2, PALB2, or TP53 gene.
  • The study doctor decides that taking part is not suitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Invasive ductal carcinoma or favorable special histology confirmed by core biopsy. * Unifocal tumor ≤2 cm; estrogen receptor-positive and HER2-negative; grade 1-2; clinically node-negative (cN0). * Age ≥65, or age 50-64 when surgery is unsuitable or declined (capped at 10 of 30 participants). * Tumor ≥5 mm from skin and pectoralis; willing to receive adjuvant endocrine therapy. * Zubrod performance status 0-2; able to undergo MRI and FDG PET/CT; informed consent. Exclusion Criteria: * Multifocal or multicentric disease; pure DCIS; invasive lobular carcinoma \>10%; extensive intraductal component or diffuse calcifications. * Grade 3, triple-negative, or HER2-positive disease; nodal or distant metastases. * Prior ipsilateral breast radiation or excisional biopsy/lumpectomy; neoadjuvant chemotherapy. * Tumor \<5 mm from skin or pectoralis; inability to meet dose constraints or PTV \>60 cm³. * Connective tissue disease; prohibited other malignancy; pregnancy or lactation. * Pathogenic BRCA1, BRCA2, PALB2, or TP53 variant; investigator judgment that participation is inappropriate.

Study sites (1)

FL