Partial Radiation for Breast Cancer

Not currently recruiting at 9 trial locations

Overseen By Christian Misdary

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Chemotherapy, Hormone therapy

Disqualifiers: Metastatic disease, BRCA+, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Accelerated Partial Breast Irradiation (APBI) to treat breast cancer by administering radiation before surgery. Researchers aim to assess the safety of this method by examining wound healing, cosmetic results, and any side effects. They also study the cancer's response to this treatment at the tissue level. This trial may suit individuals with small, non-spreading breast cancer (tumor size ≤ 2cm) that is estrogen-receptor positive. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this radiation protocol is safe for breast cancer patients?

Research has shown that Accelerated Partial Breast Irradiation (APBI) is generally safe for treating breast cancer. Studies have found that APBI causes fewer long-term side effects compared to whole breast treatment, resulting in less lasting damage to healthy tissues. APBI also improves the appearance of the treated area, making it resemble normal breast tissue more closely after treatment. Another study found that APBI has fewer harmful effects and is easier for patients to manage. However, one study noted that some individuals experienced moderate issues with soft tissue and bone later on. Overall, evidence suggests that APBI is well-tolerated, with manageable side effects for most patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast where the cancer is located, rather than the whole breast. Unlike traditional whole-breast irradiation, which can take several weeks, APBI can be completed in just a few days with five treatment sessions. Researchers are excited about this approach because it could potentially reduce treatment time and minimize radiation exposure to healthy tissues, leading to fewer side effects and a quicker recovery for patients.

What evidence suggests that Accelerated Partial Breast Irradiation (APBI) might be an effective treatment for breast cancer?

Research has shown that Accelerated Partial Breast Irradiation (APBI), which participants in this trial will receive preoperatively, can effectively treat breast cancer. Studies have found that APBI provides similar long-term results to whole-breast radiotherapy. Specifically, the breast cancer-specific survival rate is very high, about 99.6%, with APBI. Additionally, APBI has similar rates of patients remaining disease-free compared to traditional treatments, with about 84.89% over ten years. Although APBI carries a slightly higher chance of cancer returning in the same area, the likelihood of cancer spreading to other parts of the body remains the same as with standard treatment. Overall, APBI appears to be a promising option for treating breast cancer. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for breast cancer patients with conditions like Ductal Carcinoma In Situ. Participants should be eligible for surgery and have not received prior radiation therapy or chemotherapy for their breast cancer.

Inclusion Criteria

I am over 50 years old.

I am fully active or can carry out light work.

I have been diagnosed with invasive ductal cancer or DCIS in my breast.

Exclusion Criteria

I cannot receive radiation due to scleroderma or a similar condition.

I am recommended to have chemotherapy or hormone therapy before surgery.

My tumor is larger than 2cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Partial Breast Irradiation

Participants receive 5 fractions of accelerated partial breast irradiation (APBI) delivered before surgery

1 week

5 visits (in-person)

Surgery

Surgery is scheduled 1-3 weeks after radiation

1-3 weeks

Postoperative Radiation (if indicated)

Additional whole-breast or lymph node radiation may be given postoperatively if surgical pathology indicates

3-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cosmetic outcomes and late toxicities

Up to 3 years

Selected follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Partial Breast Irradiation (APBI)

Trial Overview The study tests preoperative partial breast radiation (APBI) to see if it's feasible before surgery. It looks at wound healing, cosmetic results, late side effects, and changes in the tumor due to the treatment.

How Is the Trial Designed?

Group I: Preoperative Partial Breast Irradiation Experimental Treatment 1 Intervention

Patients will receive 5 fractions of accelerated partial breast irradiation (APBI) delivered before surgery. Surgery is scheduled 1-3 weeks after radiation. If surgical pathology indicates, additional whole-breast or lymph node radiation may be given postoperatively (3-8 weeks after surgery).

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S096097762500476X

Long-term outcomes of three distinct once-daily schedules ... Once-daily accelerated partial breast irradiation is feasible. Long term outcomes are comparable with whole breast radiotherapy. Shorter schedule (<5 fractions ...

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

Long-Term Outcomes of Multimodality Accelerated Partial ... Breast cancer–specific survival (BCSS) was 99.6% at the time of analysis. There was no statistically significant difference in overall survival or recurrence ...

4. mdpi.com mdpi.com/2072-6694/16/6/1138

Ten-Year Results of Accelerated Partial-Breast Irradiation ... The 10-year disease-free survival was 87·95% (95%CI: 85.10 to 90.91) with whole-breast irradiation and 84.89% (81.97–87.91) with APBI ( ...

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01752-2

A meta-analysis of the efficacy and safety of accelerated ... The analysis showed that patients receiving APBI had a higher local recurrence rate, but no differences in distant metastasis, breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7136642/

Comparison of Toxicity and Cosmetic Outcomes After ... Conclusions. In women with breast cancer after BCS, APBI was associated with better cosmetic outcome and fewer late radiation toxicities than WBI.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960740425001203

Ten-Year Outcomes of 3D-Conformal Accelerated Partial ... In women with breast cancer after BCS, APBI was comparable to WBI in terms of LRRFS, DFS and OS. Cosmetic outcome was better in APBI arm. Late ...

8. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.22.01485

Cosmetic Results and Side Effects of Accelerated Partial ... External beam radiation therapy-APBI with a twice-daily IRMA schedule was associated with increased rates of late moderate soft tissue and bone toxicities.

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.