Accelerated Partial Breast Irradiation for Early Stage Breast Cancer

(APBI RISE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new schedule for a radiation treatment called Accelerated Partial Breast Irradiation (APBI), designed for women with early-stage, low-risk breast cancer. The researchers aim to determine if administering the treatment over five consecutive days with slightly less radiation each day is as effective as the current method, which spreads treatment over ten days. Women who have had a lumpectomy and have a unifocal tumor (a single tumor spot) may be suitable candidates. The trial seeks to make radiation therapy quicker and more convenient while maintaining its effectiveness. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to advancements in breast cancer care.

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 prior data suggests that this radiation therapy regimen is safe for early stage breast cancer?

Research has shown that accelerated partial breast irradiation (APBI) is generally safe for patients with early-stage breast cancer. A study comparing APBI to whole-breast irradiation found that many patients had excellent or good cosmetic results, meaning the treatment didn’t noticeably change the look of the breast. Another report noted that APBI usually has very low toxicity, meaning it doesn’t cause severe side effects for most people. These findings suggest that APBI is well-tolerated and safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Accelerated Partial Breast Irradiation (APBI) because it offers a more targeted and potentially less invasive approach to treating early-stage breast cancer. Unlike traditional whole-breast irradiation, which can take weeks, APBI focuses only on the part of the breast affected by cancer and can be completed in a much shorter timeframe. This approach uses advanced techniques like IMRT/VMAT, which allows for precise delivery of radiation, reducing exposure to healthy tissue and potentially minimizing side effects. These features could lead to a more convenient treatment experience and better quality of life for patients.

What evidence suggests that this accelerated partial breast irradiation is effective for early stage breast cancer?

Research has shown that accelerated partial breast irradiation (APBI) effectively treats early-stage breast cancer. The Florence trial found that APBI led to fewer immediate and long-term side effects and improved breast appearance after ten years. Other studies have demonstrated that APBI offers similar long-term results to whole breast radiotherapy but requires fewer treatment sessions. Specifically, one study reported a breast cancer-specific survival rate of 99.6%, indicating excellent effectiveness. Overall, APBI has emerged as a promising alternative to traditional whole breast irradiation for women with early-stage breast cancer. Participants in this trial will receive a novel IMRT/VMAT-based APBI regimen. ^{6 7 8 9 10}

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) 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]

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 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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9685302/

Accelerated partial breast irradiation in early stage ... The Florence trial showed statistically significant less acute and late toxicity and improved cosmetic outcomes with APBI at a median follow-up of 10 years (9).

2. nature.com nature.com/articles/s41598-025-85342-2

Quality of life in early breast cancer patients after adjuvant ... Early BC patients treated with APBI showed non-inferior short-term and late HRQoL outcomes compared to hypo-WBI. In addition to previous ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S096097762500476X

Long-term outcomes of three distinct once-daily schedules ... Once-daily accelerated partial breast irradiation is feasible. Long term outcomes are comparable with whole breast radiotherapy. Shorter schedule (<5 fractions ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00079-X/fulltext

Long-Term Outcomes of Multimodality Accelerated Partial ... Breast cancer–specific survival (BCSS) was 99.6% at the time of analysis. There was no statistically significant difference in overall survival or recurrence ...

5. abs.amegroups.org abs.amegroups.org/article/view/6912/html

Accelerated partial breast irradiation: current status and future ... APBI has been studied in a number of clinical trials as an alternative to whole breast irradiation in women with early-stage breast cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7856797/

A meta-analysis of the efficacy and safety of accelerated ... This meta-analysis evaluated the efficacy and safety of accelerated partial breast irradiation versus whole-breast irradiation for early-stage breast cancer

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1049704/full

Accelerated partial breast irradiation in early stage ... However, the Barcelona trial using 3D-CRT and similar fractionation to the RAPID trial showed > 75% of patients in the APBI arm had excellent or good cosmesis ...

8. breastsurgeons.org breastsurgeons.org/docs/statements/Consensus-Statement-for-Accelerated-Partial-Breast-Irradiation.pdf

Resource Guide on Accelerated Partial Breast Irradiation APBI has been studied as an alternative to whole breast radiation to potentially increase the number of individuals eligible for breast conservation. APBI can ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624035144

Accelerated Partial Breast Irradiation for Early-Stage ... These findings suggest that patients with early-stage ILC may be reasonably considered for APBI after lumpectomy.

10. accc-cancer.org accc-cancer.org/docs/Documents/oncology-issues/articles/2003-2016/2013/MA13/ma13-accelerated-partial-breast-irradiation

Accelerated Partial Breast Irradiation In our expe- rience, breast brachytherapy delivers: • More precise targeting of the radiation dose, resulting in better cosmesis, very low toxicity, and ...