Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer

(BreaStBRT Trial)

Overseen By Imran Zoberi, M.D.

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: Distant metastases, Multicentric carcinoma, Positive axillary nodes, others

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: 7

Duration: 1 week

134 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had neoadjuvant hormone therapy, chemotherapy, or biologic therapy before the trial, and any planned chemotherapy or biologic therapy must wait at least 4 weeks after the trial treatment.

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 shorter treatment times and smaller radiation areas. Studies report good cosmetic results and no significant increase in cancer recurrence, making it a safe and convenient option for many women. ^{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 its safety over several years of follow-up. ^{2 4 6 7 8}

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

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 traditional six-week course of whole breast irradiation. This shorter treatment time can make it more convenient for patients and reduce unnecessary radiation exposure to healthy breast tissue. ^{1 2 4 9 10}

Research Team

Imran Zoberi, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for postmenopausal women over 50 with early-stage breast cancer (Stage 0 or I) that's hormone receptor-positive and HER2/neu gene negative. Candidates must have had a partial mastectomy with clear margins, no positive lymph nodes, and not received prior non-hormonal therapy for the current cancer. They should be in good health without life-limiting conditions.

Inclusion Criteria

My breast cancer is hormone receptor positive and not HER2 positive, or it is a non-invasive type that is hormone receptor positive.

My radiation therapy will be done at BJH or its specific locations.

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

Exclusion Criteria

I have a health condition that may limit my life to less than 2 years.

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

My surgery showed cancer cells at the edge of the removed tissue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single fraction or five fractions of accelerated partial breast irradiation

1 week

1-5 visits (in-person)

Follow-up

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

5 years

Regular follow-up visits at 6 months, 12 months, 24 months, 36 months, 4 years, and 5 years

Treatment Details

Interventions

• Accelerated Partial Breast Irradiation

Trial Overview The study compares two radiation therapies after breast-conserving surgery: one single fraction vs. five fractions of accelerated partial breast irradiation (APBI). It aims to assess which method better controls cancer, has fewer complications, yields better cosmetic results, and improves quality of life.

Participant Groups

Group I: Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction) Experimental Treatment 1 Intervention

-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)

Group II: Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions) Experimental Treatment 1 Intervention

-External Beam APBI 30 Gy in 5 fractions over 5 days.

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?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Findings from Research

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]

References

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

The American Brachytherapy Society consensus statement for accelerated partial breast irradiation. [2022]

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

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

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

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