Accelerated Partial Breast Irradiation for Early Stage Breast Cancer

(APBI RISE Trial)

Recruiting at 2 trial locations

Overseen By Jan Wernisch

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Sanford Health

Disqualifiers: Pregnancy, Grade 3 carcinoma, Lobular carcinoma, Prior radiation, 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)

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

91 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that any prior treatment with radiation therapy or hormonal therapy for the currently diagnosed breast cancer is not allowed before enrollment. It's best to discuss your current medications with the trial team.

What safety data is available for accelerated partial breast irradiation (APBI) in early stage breast cancer?

Several studies provide safety data for accelerated partial breast irradiation (APBI) in early stage breast cancer. A single institution study with an 8-year follow-up compared locoregional recurrence rates between APBI and whole breast irradiation (WBI), suggesting APBI as a viable option. A 5-year phase 3 trial showed non-inferiority of APBI compared to WBI in low-risk patients. Patient-reported outcomes indicate APBI is well-tolerated with manageable acute toxicity. A systematic review and meta-analysis of 8653 women across eight trials further supports the safety and effectiveness of APBI. Overall, APBI is considered a safe, effective, and convenient treatment for early stage breast cancer. ^{1 2 3 4 5}

Is accelerated partial breast irradiation (APBI) safe for humans?

Accelerated partial breast irradiation (APBI) has been shown to be a well-tolerated treatment option for early-stage breast cancer, with studies reporting on patient-reported outcomes and acute toxicity. It is considered safe and effective, especially for women over 40 who have undergone breast-conserving surgery. ^{1 2 3 4 5}

Is Accelerated Partial Breast Irradiation a promising treatment for early stage breast cancer?

Yes, Accelerated Partial Breast Irradiation (APBI) is a promising treatment for early stage breast cancer. It allows treatment to be completed in a shorter time, often just five days, compared to the longer traditional methods. This makes it more convenient and accessible for many women, especially those who might face challenges with longer treatment schedules. APBI has been shown to be safe and effective, offering a good option for women who have had a lumpectomy and meet certain criteria. ^{1 4 5 6 7}

How is Accelerated Partial Breast Irradiation (APBI) different from other breast cancer treatments?

Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast where cancer was removed, allowing treatment to be completed in just five days, compared to the longer six-week course of whole-breast irradiation (WBI). This shorter treatment time can make it more convenient and accessible for women, especially those who face challenges with time and travel. ^{1 4 5 6 7}

What data supports the idea that Accelerated Partial Breast Irradiation for Early Stage Breast Cancer is an effective treatment?

The available research shows that Accelerated Partial Breast Irradiation (APBI) is an effective treatment for early-stage breast cancer. A systematic review and meta-analysis of 8653 women in eight randomized trials found that APBI allows treatment in a shorter time and smaller area compared to whole-breast irradiation (WBI). A single institution study with an 8-year follow-up reported that APBI addresses the disadvantages of longer treatment times and unnecessary radiation associated with WBI. Additionally, a study on APBI using a 5-fraction prone technique showed positive long-term outcomes. Another study highlighted that APBI is a safe, effective, and convenient option for many women with early-stage breast cancer. Finally, early Australian experience with APBI reported good to excellent cosmetic results and no local or systemic cancer spread in patients followed for over three years. ^{1 4 5 8 9}

What data supports the effectiveness of the treatment Accelerated Partial Breast Irradiation for early-stage breast cancer?

Research shows that Accelerated Partial Breast Irradiation (APBI) is effective for early-stage breast cancer, offering similar outcomes to whole-breast irradiation (WBI) but with a shorter treatment time and smaller radiation area. Studies report good cosmetic results and no significant increase in cancer recurrence, making it a safe and convenient option for many women. ^{1 4 5 8 9}

Who Is on the Research Team?

Ryan Nowak, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

This trial is for women over 50 with early-stage, low-risk breast cancer who've had a lumpectomy. They must not be pregnant, agree to birth control during treatment, and have no history of certain breast cancers or treatments. The tumor should be small, unifocal without aggressive features, and they should have a life expectancy of at least 5 years.

Inclusion Criteria

Ability to provide informed written consent

My tumor is positive for estrogen or progesterone and not strongly positive for HER2.

The area treated by lumpectomy is clearly marked and is less than 30% of my breast size.

Exclusion Criteria

I have Paget's disease of the nipple.

I have a collagen vascular disease like SLE or scleroderma.

Pregnant women, or women of childbearing potential who are unwilling to employ adequate contraception

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a novel IMRT/VMAT-based accelerated partial breast irradiation regimen with five once daily treatments over consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with yearly mammograms and breast exams

2 years

Yearly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Partial Breast Irradiation

Trial Overview The study tests a modified accelerated partial breast irradiation (APBI) regimen for treating favorable risk breast cancer. It involves five daily radiation treatments over consecutive days using IMRT/VMAT technology with lower doses compared to standard APBI.

How Is the Trial Designed?

Group I: IMRT/VMAT-Based Accelerated Partial Breast Irradiation Experimental Treatment 1 Intervention

Patients will be treated with a novel IMRT/VMAT-based accelerated partial breast irradiation regimen.

Accelerated Partial Breast Irradiation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Approved in European Union as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Approved in Canada as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

University of North Dakota

Collaborator

Trials

17

Recruited

1,200+

Published Research Related to This Trial

Accelerated partial breast irradiation (APBI) is linked to a higher local recurrence rate of breast cancer compared to whole-breast irradiation (WBI), with a significant hazard ratio of 4.54 based on a meta-analysis of 1407 participants.

Despite the increased local recurrence with APBI, there were no significant differences in nodal recurrence, systemic recurrence, overall survival, or mortality rates between the two treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial irradiation for breast cancer: systematic review and meta-analysis of 8653 women in eight randomized trials. Marta, GN., Macedo, CR., Carvalho, Hde A., et al.[2022]

In a study of 290 patients receiving accelerated partial breast irradiation (APBI) with a median follow-up of 8 years, the rate of ipsilateral breast tumor recurrence (IBTR) was significantly higher (6.2%) compared to 1.0% in 290 patients receiving whole breast irradiation (WBI), indicating a greater risk of recurrence with APBI.

Despite the higher recurrence rates, APBI was associated with significantly fewer toxicities, such as fatigue and skin reactions, suggesting that while APBI may pose a higher risk of cancer recurrence, it offers a more tolerable treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Institution Retrospective Comparison Study of Locoregional Recurrence After Accelerated Partial Breast Irradiation Using External Beam Fractionation Compared with Whole Breast Irradiation with 8 Years of Follow-Up. Shah, S., Kyrillos, A., Kuchta, K., et al.[2018]

In a study of 331 patients treated with 5-fraction prone accelerated partial breast irradiation (APBI), the 5-year local recurrence-free survival rate was an impressive 99.5%, indicating high efficacy in preventing cancer recurrence.

The treatment resulted in low rates of acute side effects, with no grade 3 toxicity reported, and high patient satisfaction regarding cosmetic outcomes, with 89.4% rating their results as good to excellent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Fraction Prone Accelerated Partial Breast Irradiation: Long-Term Oncologic, Dosimetric, and Cosmetic Outcome. Shah, BA., Xiao, J., Oh, C., et al.[2022]

Accelerated partial breast irradiation (APBI) is a highly effective and well-tolerated treatment for early-stage breast cancer, particularly for women who meet specific criteria such as being over 40 years old and having tumors smaller than 3 cm.

APBI offers a convenient treatment option post-lumpectomy, making it important for patients and caregivers to consider this approach for managing early-stage breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: A Safe, Effective, and Convenient Early Breast Cancer Treatment Option. Thomas, MA., Ochoa, LL., Zygmunt, TM., et al.[2018]

In a pilot program of accelerated partial breast irradiation (APBI) involving seven women with early-stage breast cancer, patients were followed for an average of 42.7 months, showing promising results.

The treatment resulted in good to excellent cosmetic outcomes, with no cases of loco-regional relapse or systemic metastases reported, indicating its potential efficacy and safety for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using interstitial high dose rate iridium brachytherapy: Early Australian experience and review of the literature. Stevens, MJ., Cooper, SG., Cross, P., et al.[2018]

In a phase 3 trial involving 1184 patients with early-stage breast cancer, accelerated partial breast irradiation (APBI) was found to be not inferior to whole-breast irradiation in terms of local recurrence rates after 5 years, with local recurrence rates of 1.44% for APBI and 0.92% for whole-breast irradiation.

APBI showed a lower risk of severe late side effects, with no grade 4 side effects reported and a 5-year risk of grade 2-3 side effects to the skin at 3.2% compared to 5.7% for whole-breast irradiation, suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Strnad, V., Ott, OJ., Hildebrandt, G., et al.[2022]

In a study of 55 patients undergoing accelerated partial breast irradiation (APBI), common acute toxicities included moderate breast enlargement (22% of patients) and severe skin toxicity (27%), with symptoms typically resolving by 8 weeks post-treatment.

Despite the reported toxicities, the study found no significant correlation between dosimetric parameters and the severity of symptoms, indicating that further research is needed to better understand how treatment planning may influence patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: Association of Dosimetric Parameters With Patient-Reported Outcomes. Lapen, K., Fiasconaro, M., Zhang, Z., et al.[2023]

Accelerated Partial Breast Irradiation (APBI) offers a promising alternative to conventional six-week radiotherapy, allowing women with early-stage breast cancer to complete treatment in just five days, which may increase access to breast conservation options.

Successful outcomes with APBI depend heavily on careful patient selection and quality assurance in brachytherapy, highlighting the importance of these factors in ensuring effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Arthur, DW., Vicini, FA., Kuske, RR., et al.[2015]

Accelerated Partial Breast Irradiation (APBI) offers a promising alternative to traditional six-week radiotherapy, allowing women with early-stage breast cancer to complete treatment in just five days, potentially increasing access to breast conservation options.

Successful outcomes with APBI depend heavily on careful patient selection and quality assurance in brachytherapy, highlighting the importance of these factors in ensuring effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. Arthur, DW., Vicini, FA., Kuske, RR., et al.[2015]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Accelerated partial irradiation for breast cancer: systematic review and meta-analysis of 8653 women in eight randomized trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Single Institution Retrospective Comparison Study of Locoregional Recurrence After Accelerated Partial Breast Irradiation Using External Beam Fractionation Compared with Whole Breast Irradiation with 8 Years of Follow-Up. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Five-Fraction Prone Accelerated Partial Breast Irradiation: Long-Term Oncologic, Dosimetric, and Cosmetic Outcome. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: A Safe, Effective, and Convenient Early Breast Cancer Treatment Option. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation using interstitial high dose rate iridium brachytherapy: Early Australian experience and review of the literature. [2018]

6. England pubmed.ncbi.nlm.nih.gov

5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation: Association of Dosimetric Parameters With Patient-Reported Outcomes. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: an updated report from the American Brachytherapy Society. [2015]