68 Participants Needed

SBRT for Early Stage Breast Cancer

ED
Overseen ByEileen Duffy, BNS OCN
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100).The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is SBRT generally safe for humans?

SBRT, also known as SABR, has been used safely in treating various cancers, including lung cancer, but some serious complications have been reported. The risk of severe side effects can increase when tumors are near sensitive areas like the bronchial tree. Strategies to reduce these risks are important to ensure safety.12345

How is the treatment SBRT different from other treatments for early-stage breast cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation precisely to the tumor in a few sessions, making it a noninvasive option for patients who cannot undergo surgery. This approach is particularly novel for early-stage breast cancer, as it can effectively treat the cancer with minimal impact on surrounding healthy tissue.26789

What data supports the effectiveness of the treatment SBRT for early-stage breast cancer?

Stereotactic ablative radiotherapy (SABR), which is similar to SBRT, has shown effectiveness in treating early-stage lung cancer and oligometastatic breast cancer, suggesting it could be beneficial for early-stage breast cancer as well. It is known for precisely targeting tumors with high doses of radiation, improving tumor control and survival rates in other cancers.68101112

Who Is on the Research Team?

RB

Rachel Blitzblau, MD PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for women aged 60+ or those 50-59 with a low Oncotype score, diagnosed with early-stage breast cancer (ER+, HER2-) that's less than or equal to 2cm. They must have normal blood counts, be candidates for breast preservation, and agree to use contraception if of child-bearing potential. It excludes HER2 positive patients, those who've had neoadjuvant chemotherapy, pregnant women, and anyone unable to undergo the treatment due to medical conditions.

Inclusion Criteria

My cancer is estrogen receptor positive and HER2 negative.
Women of child-bearing potential must consent to use adequate contraception
Tissue samples from other hospitals will be checked again to confirm the diagnosis.
See 7 more

Exclusion Criteria

My cancer is HER2 positive.
I did not have a clip placed during my biopsy and I do not want one now.
Your treatment plan cannot be followed.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Radiotherapy

Participants receive a single fraction of 21Gy stereotactic radiotherapy before surgery

1 day
1 visit (in-person)

Surgery

Participants undergo surgery following radiotherapy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cosmesis and gene expression assessments

3 years
Regular visits (in-person and virtual) at designated timepoints

Long-term Follow-up

Annual clinical examination combined with breast imaging to assess local control

5-10 years

What Are the Treatments Tested in This Trial?

Interventions

  • SBRT
Trial Overview The study tests preoperative single-fraction radiotherapy delivering 21Gy in one session for early-stage breast cancer patients. The goal is to assess cosmetic outcomes using the NRG cosmesis scale at various intervals post-treatment up to three years.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single arm 21Gy stereotactic radiotherapyExperimental Treatment1 Intervention
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
🇪🇺
Approved in European Union as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
  • Bone metastases
🇨🇦
Approved in Canada as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
🇯🇵
Approved in Japan as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Gateway for Cancer Research

Collaborator

Trials
47
Recruited
2,500+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.
The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial.David, S., Tan, J., Savas, P., et al.[2020]
Stereotactic ablative radiation therapy (SABR) was found to be effective for treating pulmonary metastases, with a median follow-up of 23 months showing improved overall survival (OS) for patients with 3 or fewer metastases compared to those with more (74.2% vs. 59.3% at 24 months).
Patients with less responsive primary tumors (like adrenal or pancreatic cancers) had higher local failure rates, suggesting that higher doses of SABR or surgical options may be necessary for these cases to improve treatment outcomes.
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure.Pasalic, D., Lu, Y., Betancourt-Cuellar, SL., et al.[2021]
Stereotactic ablative radiotherapy (SABR) shows high effectiveness for oligometastatic breast cancer, achieving local control rates of 97% at 1 year and 90% at 2 years, based on a meta-analysis of 10 studies involving 467 patients.
SABR is associated with a low toxicity rate, with only 4.1% of patients experiencing grade 2 or 3 side effects, indicating it is a safe treatment option for this patient population.
Stereotactic body radiotherapy to treat breast cancer oligometastases: A systematic review with meta-analysis.Viani, GA., Gouveia, AG., Louie, AV., et al.[2021]

Citations

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]
Stereotactic body radiotherapy to treat breast cancer oligometastases: A systematic review with meta-analysis. [2021]
A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. [2022]
Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. [2022]
Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. [2023]
An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]
Long-term outcomes in patients with central and ultracentral non-small cell lung cancer treated with stereotactic body radiotherapy: single-institution experience. [2023]
A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). [2022]
Definitive single fraction stereotactic ablative radiotherapy for inoperable early-stage breast cancer: A case report. [2021]
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]
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