Partial Breast Irradiation with CyberKnife for Breast Cancer

(CKPBI Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Essentia Health

Disqualifiers: Prior radiotherapy, Neoadjuvant chemotherapy, Multicentric disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether CyberKnife radiotherapy can safely and effectively treat breast cancer after a lumpectomy. The treatment targets only the affected part of the breast with precise radiation in short, twice-daily sessions over five days. Researchers will assess how well the therapy controls cancer and any side effects it might cause. This trial suits women aged 60 or older who have had a lumpectomy for early-stage breast cancer and meet specific medical criteria, such as being estrogen receptor-positive and having no cancer spread to the lymph nodes. As an unphased trial, this study allows participants to contribute to innovative research that could lead to more precise and effective breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that CyberKnife radiotherapy is safe for partial breast irradiation?

Research has shown that using CyberKnife for partial breast irradiation appears promising in terms of safety. Studies have found that patients generally tolerate this treatment well. Some studies indicate that the CyberKnife system can accurately target the tumor while sparing nearby healthy tissue, reducing the risk of harming other parts of the body.

Moreover, the treatment is as safe and effective as whole breast irradiation. No major reports of serious side effects specific to this method have emerged in the studies reviewed. Instead, CyberKnife treatment allows for precise targeting, which can help reduce potential side effects.

Overall, research suggests that this treatment is a safe option for patients with early-stage breast cancer after a lumpectomy. However, discussing any concerns with a healthcare provider before joining a clinical trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CyberKnife for treating early-stage breast cancer because it offers a unique approach compared to the standard treatments like whole-breast radiation. Unlike traditional radiation therapy, which often requires several weeks of daily sessions, CyberKnife uses stereotactic radiotherapy to deliver highly targeted radiation in a much shorter timeframe. This precision reduces exposure to healthy surrounding tissues, potentially minimizing side effects and improving the patient's quality of life. Additionally, the accelerated treatment schedule can be more convenient for patients, allowing them to return to their daily routines faster.

What evidence suggests that CyberKnife is effective for breast cancer?

Research shows that CyberKnife radiotherapy is effective for early-stage breast cancer. In this trial, participants will receive accelerated partial breast irradiation (APBI) using CyberKnife, which studies have found to be both safe and effective. This method targets radiation directly to the breast, significantly reducing treatment time. Evidence indicates it achieves a high rate of tumor control, with about 90% of women experiencing no cancer recurrence after treatment. Additionally, it tends to cause only mild side effects, and patients generally report satisfaction with the appearance of their breast afterward. These findings suggest that CyberKnife could be a promising treatment option for breast cancer patients post-surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Ken Dornfeld, MD

Principal Investigator

Essentia Health Oncology

Are You a Good Fit for This Trial?

This trial is for individuals aged 60 or older with early-stage breast cancer, specifically unicentric invasive ductal malignancy at stage T1. Participants must have had a lumpectomy with clear margins of at least 2mm and no nodal metastases (N0). They should not have received prior radiotherapy to the breast, chemotherapy before surgery, or have multicentric disease or node-positive disease.

Inclusion Criteria

The trial is only open to individuals with cancer that is located in one specific area of the body.

My cancer surgery removed all visible cancer with a clear margin of at least 2mm.

My cancer is estrogen receptor positive.

Exclusion Criteria

My breast cancer has a significant intraductal component.

My cancer is present in multiple locations within the same organ.

My cancer has spread to nearby lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive accelerated stereotactic radiotherapy using CyberKnife for partial breast irradiation, delivered twice daily for five days

1 week

10 sessions (in-person)

Follow-up

Participants are monitored for disease control and toxicity, with periodic physical exams and imaging for 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• CyberKnife

Trial Overview The study tests if CyberKnife stereotactic radiotherapy is a feasible and safe option for partial breast irradiation after lumpectomy. It involves ten sessions over five days. The focus will be on short-term and long-term safety as well as effectiveness in tumor control and potential failure sites.

How Is the Trial Designed?

Group I: Stereotactic radiotherapy Experimental Treatment 2 Interventions

Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.

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

Approved in United States as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Approved in European Union as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Approved in Canada as CyberKnife Radiosurgery for:

• Renal Cell Carcinoma
• Primary Renal Cell Carcinoma
• Localized Renal Cell Carcinoma

Who Is Running the Clinical Trial?

Essentia Health

Lead Sponsor

Trials

27

Recruited

107,000+

Published Research Related to This Trial

Cyberknife stereotactic body radiation therapy (SBRT) delivers high doses of radiation in fewer sessions, making it a promising alternative to surgery for early-stage primary cancers and for patients with oligometastatic disease.

Despite some uncertainties about the effects of hypofractionation, early results show good local control and patient tolerance, leading to increased use of this treatment under strict quality assurance and ongoing clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cyberknife robotic stereotactic radiotherapy: technical aspects and recent developments]. Thariat, J., Marcié, S., Marcy, PY., et al.[2018]

CyberKnifeTM stereotactic body radiotherapy (SBRT) showed effectiveness in reducing the size of tumors in patients with advanced pancreaticobiliary malignancies, with an average decrease in tumor size observed in the first three months after treatment.

However, serious complications were reported, including two cases of massive duodenal ulcer bleeding, highlighting the need for careful monitoring and further studies to evaluate the safety and long-term efficacy of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An experience of cyberknife treatment in patients with advanced pancreaticobilliary malignancy]. Jung, YH., Choi, HS., Cheon, YK., et al.[2019]

The Cyberknife® system, used for stereotactic body radiation therapy (SBRT), shows promising efficacy in treating localized prostate cancer, with median PSA levels dropping significantly after treatment and biochemical progression-free survival rates ranging from 78.3% to 100% over a follow-up period of 4 to 60 months.

While the treatment is associated with mostly mild side effects (grade 1/2), there are reports of erectile dysfunction and some grade 3 toxicities, indicating a need for further long-term studies and randomized trials to establish its safety and effectiveness as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. Seisen, T., Drouin, SJ., Phé, V., et al.[2018]

In a study of 106 patients with early-stage non-small cell lung cancer treated with CyberKnife® SBRT, the treatment demonstrated an 88% local control rate at 2 years, indicating its efficacy in managing this type of cancer.

The treatment was associated with low toxicity, with only 20% of patients experiencing mild fatigue and 17% mild dyspnea, and only 4% experiencing significant late effects, suggesting it is a safe option for medically inoperable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-adapted robotic stereotactic body radiation therapy for inoperable early-stage non-small-cell lung cancer. Temming, S., Kocher, M., Stoelben, E., et al.[2022]

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) demonstrated a 2-year overall survival rate of 64.0% in patients with recurrent hepatocellular carcinoma (HCC), significantly better than the 42.1% survival rate in matched controls not receiving SBRT.

The treatment was found to be safe, with only mild and tolerable acute toxicities, indicating that SBRT is an effective option for improving survival in patients with unresectable HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in recurrent hepatocellular carcinoma. Huang, WY., Jen, YM., Lee, MS., et al.[2022]

Cyberknife stereotactic body radiation therapy (SBRT) was found to be safe and effective for treating unresectable huge hepatocellular carcinoma (HCC), with an objective response rate of 86.3% and a median survival of 11 months among 22 patients treated between 2009 and 2011.

The study indicated that the dose of SBRT significantly influenced survival outcomes, with a 1-year overall survival rate of 50%, suggesting that SBRT could be a viable salvage treatment option for patients with large HCC, despite the risk of local and regional recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of stereotactic body radiation therapy on huge hepatocellular carcinoma unsuitable for other local modalities. Que, JY., Lin, LC., Lin, KL., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624001279

Stereotactic body radiotherapy using CyberKnife versus ... Previous clinical studies have demonstrated that APBI is an effective and time-saving method of postoperative radiotherapy in early breast cancer treatment, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4876543/

Stereotactic Accelerated Partial Breast Irradiation for Early ... Accelerated partial breast irradiation is safe and effective using intensity-modulated radiation therapy in selected early-stage breast cancer.

3. tcr.amegroups.org tcr.amegroups.org/article/view/2871/3450

CyberKnife stereotactic body radiotherapy and CyberKnife ... However, published data documents that 90% of breast cancer recurrences in women with early stage disease (stage 0-III) treated with lumpectomy with clear 2 mm ...

4. redjournal.org redjournal.org/article/s0360-3016(17)30028-7/fulltext

Preliminary Results of a Phase 1 Dose-Escalation Trial for ... Preliminary Results of a Phase 1 Dose-Escalation Trial for Early-Stage Breast Cancer Using 5-Fraction Stereotactic Body Radiation Therapy for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5865347/

Partial breast irradiation with CyberKnife after ... These preliminary results showed the safe feasibility of CK-APBI in early breast cancer, with mild acute and late toxicity and very good cosmetic results.

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)04367-3/fulltext

30P Stereotactic body radiotherapy using cyberknife ... This study was designed to compare the dosimetric characteristics of organ at risk and the clinical outcome between two different techniques.