Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Adjuvant hormone therapy

Must not be taking: Neoadjuvant hormone therapy

Disqualifiers: Metastases, Multicentric carcinoma, Lupus, 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)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy to individuals with low-risk, early-stage breast cancer. The goal is to determine if a low dose of radiation over a short period can effectively treat cancer while reducing side effects. The treatment, called Three Fraction APBI (Accelerated Partial Breast Irradiation), involves three radiation sessions, potentially increasing accessibility at many medical centers. Individuals who have undergone a partial mastectomy for early-stage breast cancer and have not received other cancer treatments might be suitable candidates. Participants must receive their radiation treatment at a specific hospital. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed before the trial, but adjuvant hormone therapy can be started after surgery. It's best to discuss your current medications with the trial team.

What prior data suggests that this approach is safe for early-stage breast cancer patients?

A previous study found that Three Fraction Accelerated Partial Breast Irradiation (APBI) is safe for treating early-stage breast cancer. Patients received the treatment in three doses over two to three days. Research shows that side effects were usually mild, and most patients reported that the treated area looked normal after healing, with good to excellent cosmetic results. Severe side effects were not commonly reported.

Other studies have shown that APBI is well-tolerated, allowing patients to undergo the treatment without serious issues. Long-term follow-up data supports its safety and effectiveness for early-stage breast cancer, indicating that the treatment remains promising over time.

Overall, evidence suggests that Three Fraction APBI is generally safe for treating early-stage breast cancer in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for early-stage breast cancer, which often involves several weeks of radiation therapy, the treatment under study offers an accelerated approach. Researchers are excited about this method because it involves delivering high-dose radiation in just three fractions over two to three days, either through brachytherapy or external beam radiation. This condensed schedule not only promises to reduce treatment time significantly but may also improve patient convenience and quality of life while maintaining effective cancer control.

What evidence suggests that Three Fraction APBI is effective for early-stage breast cancer?

Research has shown that Accelerated Partial Breast Irradiation (APBI) effectively treats early-stage breast cancer. Trials such as RAPID and NSABP-B39 found that APBI works well for patients with low-risk breast cancer. In this trial, participants will receive the Three Fraction APBI, involving three treatment sessions. Early results from this method are promising. Patients tolerated the treatment well, with no serious side effects reported. This method targets radiation to the cancer area, minimizing its impact on the rest of the body, making it a potentially groundbreaking approach for breast cancer care. ^{1 3 4 6 7}

Who Is on the Research Team?

Imran Zoberi, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for English-speaking postmenopausal women aged 50 or older with stage 0 or I breast cancer treated by partial mastectomy. They should have no prior non-hormonal therapy for the current cancer, no positive lymph nodes, and must be within 8 weeks of their last definitive breast procedure. Candidates cannot have certain other diseases, a history of other malignancies within the past 5 years (except some skin cancers), or extensive surgery that affects cosmetic outcomes.

Inclusion Criteria

Able to understand and willing to sign IRB-approved written informed consent document.

My breast cancer is early stage, treated with partial mastectomy, and no spread to lymph nodes.

My breast surgery removed all the cancer with clear margins.

Exclusion Criteria

I have multiple tumors in one breast, confirmed by biopsy.

I have had treatments like radiation or chemotherapy for my current breast cancer.

I have been diagnosed with lupus, scleroderma, or dermatomyositis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Three Fraction Accelerated Partial Breast Irradiation (Tri-APBI) with either brachytherapy or external beam radiation over two to three days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and changes in cosmesis and quality of life after treatment

5 years

Regular visits at 6-10 weeks, 4-8 months, 10-14 months, and yearly intervals

What Are the Treatments Tested in This Trial?

Interventions

• Three Fraction APBI

Trial Overview

The study tests Three Fraction Accelerated Partial Breast Irradiation (Tri-APBI) as the only radiation treatment after partial mastectomy in low-risk early-stage breast cancer patients. It aims to minimize adjuvant therapy impact using commonly available equipment at many oncology centers without specialized tools.

How Is the Trial Designed?

Group I: TRI-APBI Experimental Treatment 2 Interventions

* Brachytherapy TRI-APBI the PTV is prescribed 7.5 Gy x three fractions given over two to three days OR * External beam TRI-APBI the PTV is prescribed 8.5 Gy x three fractions given over two to three days

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

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 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 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]

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]

In a study of 127 women with early-stage breast cancer treated with accelerated partial breast irradiation (APBI), the treatment showed excellent disease-free survival at 3 years, with a 97% rate and only one local recurrence.

Most treatment-related toxicities were mild (Grade 1), with acceptable cosmetic outcomes, as 82% of women reported good to excellent cosmesis at the 3-year follow-up, supporting the safety and efficacy of APBI for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year outcomes of a Canadian multicenter study of accelerated partial breast irradiation using conformal radiation therapy. Berrang, TS., Olivotto, I., Kim, DH., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7373303/

Three-Fraction Accelerated Partial Breast Irradiation (APBI ...

This trial treats select breast cancers after breast-conserving surgery with brachytherapy applicators that deliver 22.5 Gy in 3 fractions of 7.5 Gy.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S096097762500476X

Long-term outcomes of three distinct once-daily schedules ...

Two randomized phase 3 trials, RAPID and NSABP-B39 [9,10], with long-term follow-up data, have confirmed that APBI is effective for early-stage breast cancer, ...

3.

practicalradonc.org

practicalradonc.org/article/S1879-8500(23)00062-0/abstract

Three-Fraction Accelerated Partial Breast Irradiation (APBI) ...

The trial treated selected breast cancers after breast-conserving surgery with brachytherapy applicators that delivered 22.5 Gy in 3 fractions ...

4.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(07)00347-7/abstract

Comparison of three accelerated partial breast irradiation ...

The average EUD (normalized to 3.4Gy BID) for the MCT, MST, and 3DCRT APBI was 35, 37.2, and 37.6Gy. When normalized to 2Gy fractionation these become, 42.2, ...

5.

brachyjournal.com

brachyjournal.com/article/S1538-4721(23)00027-2/abstract

A Single-Institution Retrospective Study of Three-Fraction ...

Three-fraction HDR brachytherapy APBI was well-tolerated with no grade 3 or higher toxicities and an acceptably small percentage of grade 2 ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1879850023000620

Three-Fraction Accelerated Partial Breast Irradiation (APBI ...

Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Interstitial Brachytherapy Is Safe: First Results From the Tri-fraction Radiation ...

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 ...