Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer

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

77 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Three Fraction APBI for early-stage breast cancer?

Research shows that accelerated partial breast irradiation (APBI) is effective for early-stage breast cancer, with studies reporting good cosmetic outcomes and no significant cancer recurrence. Similar treatments, like the five-fraction APBI, have been used successfully for over a decade, supporting the potential effectiveness of the three-fraction approach. ^{1 2 3 4 5}

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

Research shows that accelerated partial breast irradiation (APBI) is generally well-tolerated, with studies reporting on both short-term and long-term safety outcomes. Patients have reported manageable side effects, and the treatment has been used safely in various forms for early-stage breast cancer. ^{3 4 6 7 8}

How does Three Fraction APBI treatment differ from other treatments for early-stage breast cancer?

Three Fraction APBI is unique because it delivers radiation to a smaller area of the breast over a shorter period, typically in just three sessions, compared to traditional whole-breast irradiation which covers the entire breast and takes several weeks. This approach can reduce treatment time and potentially minimize side effects while still effectively targeting cancer cells. ^{2 3 4 9 10}

What is the purpose of this trial?

The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).

Research Team

Imran Zoberi, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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) 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 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]

References

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

Impact of lymph node status on clinical outcomes after accelerated partial breast irradiation. [2012]

2. Germany pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation with external beam radiotherapy : First results of the German phase 2 trial. [2018]

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

Is oncoplastic surgery a contraindication for accelerated partial breast radiation using the interstitial multicatheter brachytherapy method? [2022]

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

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

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. Italy pubmed.ncbi.nlm.nih.gov

Long-term results of a randomized partial irradiation trial compared to whole breast irradiation in the early stage and low-risk breast cancer patients after conservative surgery. [2021]

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

Three-year outcomes of a Canadian multicenter study of accelerated partial breast irradiation using conformal radiation therapy. [2018]

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

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

9. 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]

10. 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]