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

39 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Accelerated Partial Breast Irradiation (APBI) for breast cancer?

Research shows that Accelerated Partial Breast Irradiation (APBI) is effective for early-stage breast cancer, with studies indicating it provides local control similar to whole breast radiotherapy. It is a convenient option as it can be completed in a shorter time, and results from various studies have shown good outcomes with no significant relapses. ^{1 2 3 4 5}

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

Accelerated partial breast irradiation (APBI) has been studied for early-stage breast cancer and is generally well-tolerated, with some reports of skin toxicity (skin irritation or damage) depending on the technique used. Studies have shown that it can be a safe option with manageable side effects for patients undergoing breast-conserving surgery. ^{6 7 8 9 10}

How is the treatment Accelerated Partial Breast Irradiation (APBI) different from other breast cancer treatments?

Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast where cancer was removed, and it is delivered over a much shorter period (1 to 5 days) compared to whole breast irradiation, which can take several weeks. This makes APBI more convenient and potentially less costly for patients. ^{1 2 4 5 11}

What is the purpose of this trial?

This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.

Research Team

Adam Currey, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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]

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 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]

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

Accelerated partial breast irradiation: where do we stand? [2019]

3. United States 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. [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. 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]

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

Accelerated partial breast irradiation after conservative surgery for breast cancer. [2019]

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

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

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial testing a hyaluronic acid spacer injection for skin toxicity reduction of brachytherapy accelerated partial breast irradiation (APBI): a study protocol. [2023]

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

Accelerated Partial Breast Irradiation (APBI): Where Are We Now? [2022]