Preoperative APBI for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Chemotherapy

Disqualifiers: Multifocal cancer, Lobular carcinoma, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores treating early-stage breast cancer with a special type of radiation called accelerated partial breast irradiation (APBI) before surgery. The goal is to shrink the area needing radiation, potentially reducing side effects. Advanced imaging plans the treatment, and the cancer is surgically removed several weeks later. Women with estrogen receptor-positive, early-stage invasive breast cancer, and no spread to lymph nodes might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking chemotherapy, you may not be eligible to participate.

What prior data suggests that this method is safe for preoperative use in breast cancer treatment?

Research has shown that accelerated partial breast irradiation (APBI) is generally safe and well-tolerated for many women with early-stage breast cancer. Studies have found that this type of radiation treatment usually causes fewer side effects than standard full-breast radiation. For instance, one study discovered that external beam APBI led to fewer harmful side effects compared to other common radiation treatments for breast cancer.

Common side effects of radiation treatments like APBI can include skin irritation, tiredness, and breast pain, but these are usually mild and temporary. Serious side effects are rare. Overall, APBI has been used effectively with a low risk of cancer returning in the treated breast.

In this study, using MRI (magnetic resonance imaging) instead of CT (computed tomography) scans to plan the radiation may help target the cancer more precisely, potentially improving safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Accelerated Partial Breast Irradiation (APBI) because it represents a targeted and efficient approach to treating breast cancer. Unlike traditional whole-breast radiation therapy, which can take several weeks and impact the entire breast, APBI focuses radiation only on the tumor site and is delivered in a much shorter timeframe, potentially just days. This precise targeting minimizes damage to surrounding healthy tissue, reduces side effects, and offers a more convenient treatment schedule for patients.

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

Research has shown that accelerated partial breast irradiation (APBI) effectively treats breast cancer. One study found that APBI prevented cancer recurrence in 99.4% of patients with ductal carcinoma in situ for two years after surgery. Another study noted that APBI led to excellent survival rates and cosmetic results. Compared to whole breast irradiation, APBI caused less breast shrinkage, with all patients experiencing only mild changes. Overall, APBI offers strong cancer control and good cosmetic outcomes, making it a promising treatment option for breast cancer. In this trial, participants will receive radiation therapy followed by lumpectomy to evaluate the effectiveness of this approach. ^{6 7 8 9 10}

Who Is on the Research Team?

Adam Currey, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for women over 40 with early-stage breast cancer (stage I-II), who have not been treated yet. They must be estrogen receptor positive, and can have either her2 positive or negative tumors. Participants should not be pregnant, willing to use contraception during radiation therapy, and without a history of certain other cancers or severe health conditions.

Inclusion Criteria

My recent blood test shows I have enough neutrophils, platelets, and hemoglobin.

I had cancer in my other breast but finished all treatments over five years ago.

I have had breast augmentation or implants.

Exclusion Criteria

Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent

Your doctor thinks you have 10 years or less to live.

My cancer is not driven by estrogen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive MRI-based preoperative accelerated partial breast irradiation using 3D conformal external beam irradiation

5-8 weeks

Surgery

Lumpectomy is performed to surgically remove the cancer

1 week

Follow-up

Participants are monitored for postoperative complications and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Partial Breast Irradiation
• Lumpectomy

Trial Overview The study tests if giving accelerated partial breast irradiation (APBI) using MRI before lumpectomy surgery is feasible. This could mean less breast tissue gets exposed to radiation compared to traditional methods where APBI follows the surgery.

How Is the Trial Designed?

Group I: Radiation Therapy followed by Lumpectomy Experimental Treatment 1 Intervention

Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy

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?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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]

Accelerated partial breast irradiation (APBI) shows early results indicating comparable toxicity, cosmetic outcomes, and local control to standard whole-breast irradiation, based on phase I-II studies involving around 500 patients.

Approximately 3% of patients experience local recurrence after breast-conserving surgery, whether or not they receive standard whole-breast irradiation, highlighting the need for further research to validate APBI as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation after conservative surgery for breast cancer. Kuerer, HM., Julian, TB., Strom, EA., et al.[2019]

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]

Accelerated partial breast irradiation (APBI) has been shown to be non-inferior to whole breast irradiation (WBI) in terms of long-term outcomes, with similar rates of ipsilateral breast tumor recurrence (IBTR) at 8 years (3% for APBI vs. 2.8% for WBI), based on the OCOG-RAPID trial involving patients receiving 38.5 Gy in 10 fractions.

While APBI offers reduced acute toxicity and improved convenience, it may lead to worse late toxicity and breast cosmetic outcomes compared to WBI, indicating that patient selection is crucial for its application, particularly for those with low-risk ductal carcinoma in situ or early-stage invasive ductal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Partial Breast Irradiation (APBI): Where Are We Now? Goldberg, M., Whelan, TJ.[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) is a promising new radiotherapy method for breast cancer patients, showing local control rates comparable to traditional whole breast radiotherapy in recent studies.

Ongoing phase III trials are investigating the safety and efficacy of various APBI techniques to determine if they can effectively replace whole breast radiotherapy for women opting for breast conservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: where do we stand? Dirbas, FM.[2019]

In a study of 98 patients with early-stage breast cancer treated with accelerated partial breast irradiation (APBI), the 5-year rate of ipsilateral breast tumor recurrence (IBTR) was low at 5%, indicating the treatment's efficacy, especially for estrogen receptor-positive tumors.

Patients with triple-negative breast cancer had a significantly higher IBTR rate of 33% compared to only 2% for non-triple-negative patients, suggesting that hormone receptor status is an important factor in treatment outcomes with 3D-APBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Pashtan, IM., Recht, A., Ancukiewicz, M., 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002915

Accelerated Partial Breast Irradiation (APBI) For Ductal ... Accelerated partial breast irradiation (APBI) achieved excellent local control (2-year rate: 99.4%) in patients with DCIS following lumpectomy, ...

2. esmoopen.com esmoopen.com/article/S2059-7029(25)00599-X/fulltext

176P Prospective randomized study comparing ... Of those that had WBI, 40% had moderate shrinkage, whereas with APBI, 100% had only mild shrinkage. Excellent cosmesis was achieved in 64% of APBI patients ...

3. 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6378667/

Effectiveness of different accelerated partial breast ... This systematic review was conducted to compare the effectiveness of different accelerated partial breast irradiation (APBI) techniques for the treatment of ...

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

Long-Term Outcomes of Multimodality Accelerated Partial ... APBI as a component of breast-conserving therapy for pure ductal carcinoma in situ is associated with excellent survival rates, local control, and cosmetic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6167235/

Accelerated Partial Breast Irradiation: A Safe, Effective, and ... Accelerated partial breast irradiation (APBI) is an excellent treatment option for many women with early stage breast cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6323254/

Accelerated partial breast radiotherapy: a review of the ... Throughout these studies, ipsilateral breast tumor recurrence (IBTR) rates ranged from 5.2–15% at greater than 10-year follow-up in each study with generally ...

8. 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.

9. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02412-x

Toxicity of external beam accelerated partial-breast irradiation ... External APBI demonstrated better feasibility and less toxicity than the standard regimen in the adjuvant setting for treating early breast cancer patients.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06677944

Preoperative Partial Breast Irradiation in Early-Stage ... The objective is to prove that preoperative partial breast irradiation (PBI) is not inferior in terms of radiotherapy-related side effects ...