Targeted Radiation Therapy for Breast Cancer

(Second Chance Trial)

Recruiting at 2 trial locations

Overseen By Charles Ekeh, M.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Regional recurrences, Metastatic disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat breast cancer that has returned in the same breast after previous surgery and radiation. The focus is on partial breast irradiation, a type of targeted radiation therapy that targets only the area around the original tumor site, to determine if this approach can conserve more breast tissue. It suits individuals whose breast cancer has returned in one spot, is small (less than 2-3 cm), and who received initial treatment at least a year ago. The study aims to provide another chance at breast conservation with fewer side effects. As an unphased trial, it offers patients a unique opportunity to contribute to innovative research that could lead to more personalized treatment options.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it mentions that every kind of systemic therapy is allowed. This suggests you may be able to continue your current treatments.

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

Research has shown that partial breast irradiation (PBI) is generally safe and well-tolerated. Studies have found that this treatment causes fewer changes to the breast's appearance and firmness compared to traditional whole breast radiation. In the long run, its safety and effectiveness are similar to whole breast radiotherapy.

Patients receiving partial breast irradiation often experience fewer changes to the breast, indicating it is a gentler option. This treatment targets only the area of the breast where cancer was removed, leading to fewer side effects than more extensive radiation.

The treatment's safety is supported by its use in early-stage breast cancer as an additional treatment after surgery. Guidelines recommend it for certain patients, reflecting confidence in its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Partial Breast Irradiation (PBI) is unique because it offers a faster and more targeted approach to treating breast cancer compared to traditional whole-breast radiation therapy. While standard treatments often involve several weeks of daily radiation, PBI can be completed in just 1-2 weeks, using an accelerated fractionation scheme. This not only reduces the treatment time significantly but also minimizes exposure to healthy tissues, potentially leading to fewer side effects. Researchers are excited because this method could offer a more convenient and potentially less toxic option for patients, making breast cancer treatment more patient-friendly.

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

Research has shown that partial breast irradiation (PBI), the treatment under study in this trial, can be a good option for some breast cancer patients. Studies have found that PBI, which targets only the area where the cancer was removed, can yield similar long-term results as whole-breast radiation. This approach requires fewer treatment sessions, offering more convenience for patients. However, some research suggests that PBI might not be as effective as full breast treatments in preventing cancer recurrence in the same breast. Despite this, PBI remains a valid choice for many, especially those who wish to preserve more of their breast. ^{2 4 5 6 7}

Who Is on the Research Team?

John Ng, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults who've had breast cancer return in the same breast after lumpectomy and radiation. They should have a small, single tumor (less than 2-3 cm) without skin involvement or distant spread, up to three positive lymph nodes, clear margins from surgery, and it must be at least a year since their first treatment.

Inclusion Criteria

I have up to 3 lymph nodes with cancer but no spread beyond their capsule.

Informed consent for clinical and research purposes signed

My cancer has not spread to distant parts of my body.

Exclusion Criteria

I have had targeted radiation therapy for breast cancer.

Positive histologic margins at resection

I am unhappy with how my previous surgery and radiation therapy look.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive partial breast irradiation with 30 Gy in 5 fractions over 1-2 weeks

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of adverse events and quality of life assessments

60 months

Regular visits at 6, 12, 24, 36, 48, and 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Partial Breast Irradiation

Trial Overview The study tests partial breast irradiation focused on the surgical bed with some margin around it. The aim is to see if this can offer another chance at preserving the breast in patients who've had previous lumpectomy and radiotherapy but now face recurrence.

How Is the Trial Designed?

Group I: Radiation Therapy Experimental Treatment 1 Intervention

Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT).

Partial Breast Irradiation is already approved in United States, European Union for the following indications:

Approved in United States as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

A case-control study comparing accelerated partial-breast irradiation (APBI) and conventional whole breast radiotherapy (WBRT) found no significant differences in overall survival or disease-free survival between the two treatments for early breast cancer.

APBI resulted in better cosmetic outcomes compared to WBRT, although it was associated with a slight increase in mild breast fibrosis and telangiectasias, indicating a trade-off between cosmetic benefits and some adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial-breast irradiation vs conventional whole-breast radiotherapy in early breast cancer: a case-control study of disease control, cosmesis, and complications. Wadasadawala, T., Sarin, R., Budrukkar, A., et al.[2022]

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 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 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) offers a promising alternative to whole breast irradiation for selected low-risk breast cancer patients, potentially reducing the volume of breast tissue exposed to radiation and shortening treatment duration.

Stereotactic partial breast radiotherapy has shown preliminary benefits in terms of reduced invasiveness, local toxicity, and improved cosmetic outcomes, supported by advanced imaging and planning techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic partial breast irradiation in primary breast cancer: A comprehensive review of the current status and future directions. Takanen, S., Pinnarò, P., Farina, I., et al.[2022]

Accelerated partial breast irradiation (APBI) is a promising adjuvant radiotherapy strategy for early breast cancer patients post-surgery, focusing on the tumor bed to reduce treatment duration and minimize late radiation side effects.

The review emphasizes the importance of careful patient selection for APBI based on tumor characteristics and recurrence patterns, supported by evidence from previous studies, to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation as part of breast conserving therapy of early breast carcinoma: a systematic review. Offersen, BV., Overgaard, M., Kroman, N., et al.[2022]

Breast conserving surgery combined with radiation therapy, particularly partial-breast irradiation (PBI) and accelerated partial-breast irradiation (APBI), is gaining acceptance as a viable alternative to mastectomy for early-stage breast cancer, focusing on treating only high-risk areas.

Despite emerging data on the effectiveness of PBI and APBI over 5 to 7 years, key issues such as patient selection, radiation dosing, and overall survival outcomes still need to be addressed through further research and standardized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Workshop on partial breast irradiation: state of the art and the science, Bethesda, MD, December 8-10, 2002. Wallner, P., Arthur, D., Bartelink, H., et al.[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) 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]

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) 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 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. 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. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00296-5/fulltext

Partial Breast Irradiation for Patients With Early-Stage ... This guideline provides evidence-based recommendations on appropriate indications and techniques for partial breast irradiation (PBI) for ...

4. redjournal.org redjournal.org/article/S0360-3016(22)03386-7/fulltext

A Meta-Analysis of Trials of Partial Breast Irradiation PBI was less effective than WBI in preventing ipsilateral breast events, but there was significant heterogeneity between different techniques, ...

5. nature.com nature.com/articles/s41598-025-85342-2

Quality of life in early breast cancer patients after adjuvant ... Accelerated partial breast irradiation (APBI) represents a valid option for adjuvant therapy of selected early breast cancer (BC).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5601757/

Efficacy and safety of accelerated partial breast irradiation All 7 studies reported local recurrence as an outcome. Meta-analysis of 5 trials that included 6486 patients showed significantly different 5-year local ...

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

Accelerated partial breast radiotherapy: a review of the ... Partial breast irradiation demonstrated lower rates of changes in breast appearance and firmness when compared to the control group. Lastly, the awaited NSABP ...