Oncoplastic Surgery + IORT for Breast Cancer

Overseen By Janie Weng Grumley, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Saint John's Cancer Institute

Disqualifiers: Metastatic disease, Connective tissue 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: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to breast cancer surgery for patients who have previously undergone radiation therapy. It combines oncoplastic partial mastectomy (a breast-conserving surgery) with intraoperative radiotherapy (a targeted radiation treatment during surgery) to assess whether it improves cosmetic results and reduces complications. The trial also evaluates if this method effectively prevents cancer recurrence and improves survival rates. It suits women over 50 who have experienced a breast cancer recurrence, previously received radiation, and declined a mastectomy as a treatment option. As an unphased trial, it provides a unique opportunity to explore innovative treatment options that may enhance quality of life.

Will I have to stop taking my current medications?

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

What prior data suggests that intraoperative radiotherapy and oncoplastic partial mastectomy are safe for breast cancer patients?

Research shows that intraoperative radiotherapy (IORT) for breast cancer is generally easy for patients to handle. Studies have found that IORT usually causes fewer skin problems than traditional external beam radiation. For example, one study reported that five years after treatment, over 96% of patients experienced no cancer recurrence, and all remained alive. This suggests that IORT is both effective and safe for many patients.

Regarding oncoplastic partial mastectomy, research indicates it combines cancer treatment with cosmetic surgery, aiming to remove cancer while preserving the breast's shape. Studies show that more than 95% of women avoid needing a full breast removal (mastectomy) with this method, and major complications are rare.

In summary, both IORT and oncoplastic surgery are considered safe, with a strong record of minimizing serious side effects and complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about oncoplastic surgery combined with intraoperative radiotherapy (IORT) for breast cancer because it offers a unique approach by integrating both surgery and immediate radiation treatment. Unlike the traditional approach, which usually involves multiple sessions of postoperative radiation over several weeks, this method delivers a single, concentrated dose of radiation directly to the site during surgery. This not only reduces the overall treatment time but also minimizes radiation exposure to healthy surrounding tissues, potentially leading to fewer side effects and a quicker recovery for patients.

What evidence suggests that intraoperative radiotherapy and oncoplastic partial mastectomy could be effective for breast cancer?

Research has shown that oncoplastic partial mastectomy effectively treats breast cancer. This procedure removes the tumor and employs techniques to enhance the breast's appearance. Studies indicate it provides good cancer control while preserving the breast's shape. Most women can avoid a full mastectomy, and it often results in fewer complications.

In this trial, participants will receive intraoperative radiotherapy (IORT) as part of their treatment. Studies like TARGIT-A and ELIOT found that IORT effectively prevents cancer from returning in the treated area. Long-term data shows high survival rates, with one study reporting a 97.37% survival rate without local cancer recurrence over five years. This suggests that combining these treatments could be effective for breast cancer patients, even for those who have previously undergone radiation. ^{1 2 3 6 7}

Who Is on the Research Team?

Janie G. Weng Grumley

Principal Investigator

Saint John's Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women over 50 with early-stage breast cancer who've had chest radiation before and now have a single tumor ≤3cm without spread to lymph nodes or distant organs. They must be at least one year past initial treatment, refuse mastectomy, and have enough skin distance from the tumor for safe radiation.

Inclusion Criteria

It has been at least a year since my initial breast-conserving therapy.

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

I have had radiation therapy to my entire breast or chest wall before.

Exclusion Criteria

My cancer has returned in multiple locations.

My cancer has spread to nearby lymph nodes.

My breast cancer involves the skin or muscle, or I have Paget's disease of the nipple.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo oncoplastic partial mastectomy with intraoperative radiotherapy (IORT) at the time of surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for cosmesis, perioperative complications, and effectiveness of treatment, including recurrence and survival rates

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Radiotherapy
• Oncoplastic partial mastectomy

Trial Overview The study tests oncoplastic partial mastectomy combined with IORT in patients previously treated with radiation. It's a single-group trial focusing on how well this approach works and its impact on appearance, complications, recurrence rates, necessity of full mastectomy later, and survival outcomes.

How Is the Trial Designed?

Group I: Single-arm Experimental Treatment 2 Interventions

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Oncoplastic partial mastectomy is already approved in European Union, United States for the following indications:

Approved in European Union as Oncoplastic partial mastectomy for:

• Early-stage breast cancer

Approved in United States as Oncoplastic partial mastectomy for:

• Early-stage breast cancer
• Breast cancer with prior history of chest wall radiation

Who Is Running the Clinical Trial?

Saint John's Cancer Institute

Lead Sponsor

Trials

27

Recruited

6,800+

Published Research Related to This Trial

Oncoplastic breast-conserving surgery (OBCS) combined with intraoperative radiotherapy (IORT) is safe and effective for early breast cancer, showing lower rates of postoperative complications and shorter hospital stays compared to standard breast-conserving surgery (SBCS).

Patients who underwent OBCS + IORT reported significantly better cosmetic outcomes and higher satisfaction with breast appearance, along with improved quality of life scores, indicating that this approach not only addresses cancer treatment but also enhances patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of oncoplastic breast-conserving surgery combined with intraoperative radiotherapy on early breast cancer. Liu, Q., Fang, J.[2021]

In a study of 50 women with in situ carcinoma treated with single-dose intraoperative radiation therapy (IORT) after oncoplastic breast-conserving surgery, no local recurrences were observed after a median follow-up of 46 months, indicating its efficacy.

Although 16% of patients had margins less than 2 mm and required additional therapy, the results suggest that single-dose IORT can be a safe and effective treatment option for well-selected patients with ductal carcinoma in situ (DCIS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncoplastic breast-conserving therapy and intraoperative radiotherapy for management of carcinoma in situ of the breast: A single-center experience. Crown, A., Carlson, E., Rocha, FG., et al.[2021]

Oncoplastic breast reconstruction is becoming more popular as it effectively addresses defects from partial mastectomy while maintaining good aesthetic results and comparable safety to traditional breast conservation surgery.

The choice of technique in oncoplastic surgery is influenced by various factors including patient and tumor characteristics, treatment needs, and available tissue, which helps in achieving the best possible outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncoplastic techniques and tricks to have in your toolbox. Huang, A., Wong, DE., Hanson, SE.[2023]

Oncoplastic lumpectomy is a safe alternative to standard lumpectomy for selected breast cancer patients, with similar immediate complication rates except for a higher incidence of nonhealing wounds in the oncoplastic group (8.6% vs 1.2%).

While cosmetic outcomes were generally comparable, oncoplastic patients experienced a higher rate of fat necrosis (25.9% vs 9.5%), indicating a potential trade-off in cosmetic satisfaction for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical, oncologic, and cosmetic differences between oncoplastic and nononcoplastic breast conserving surgery in breast cancer patients. Tenofsky, PL., Dowell, P., Topalovski, T., et al.[2022]

In a study of 53,165 breast cancer patients, those who underwent simultaneous oncoplastic reduction with lumpectomy had a significantly lower rate of positive margins requiring reexcision compared to those who had lumpectomy alone.

While oncoplastic reduction was associated with higher rates of certain complications, it did not delay the start of adjuvant radiation therapy, indicating that it can be a safe option for improving aesthetic outcomes without affecting treatment timelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Oncoplastic Reduction on Initiation of Adjuvant Radiation and Need for Reexcision: A Database Evaluation. Shah, JK., Lipman, K., Pedreira, R., et al.[2022]

Oncoplastic breast-conserving surgery (OPBCS) is widely practiced in the UK, with 97% of surveyed centers offering volume displacement techniques and over 40% treating more than 500 breast cancer cases annually.

There is variability in the contraindications for OPBCS, with most centers allowing it for multifocal cancers, indicating a need for further research to compare OPBCS outcomes with those of mastectomy and immediate breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current practice and provision of oncoplastic breast-conserving surgery in the UK: results of the ANTHEM national practice questionnaire. Davies, C., Whisker, L., Skillman, J., et al.[2023]

In a study of 30 patients with anaplastic thyroid carcinoma, combining surgery, chemotherapy, and hyperfractionated radiotherapy resulted in a complete local response in 19 patients, highlighting the efficacy of this treatment protocol.

The treatment was associated with significant acute toxicity, particularly hematologic issues, but showed improved long-term survival rates, especially for patients who underwent complete tumor resection before receiving radiotherapy and chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined treatment of anaplastic thyroid carcinoma with surgery, chemotherapy, and hyperfractionated accelerated external radiotherapy. De Crevoisier, R., Baudin, E., Bachelot, A., et al.[2022]

A 28-year-old woman with a malignant phyllodes tumor successfully underwent nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR), resulting in a disease-free status after 3 years and high patient satisfaction with cosmetic outcomes.

The case demonstrates that NSM with IBR can be a viable and effective treatment option for localized malignant phyllodes tumors, challenging the notion that such procedures are contraindicated in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of recurrent malignant phyllodes tumor undergoing nipple-sparing mastectomy with immediate breast reconstruction. Morioka, E., Noguchi, M., Noguchi, M., et al.[2020]

A study involving 454 patients who underwent oncoplastic surgery for invasive breast cancer showed that this approach has similar overall survival rates (91.4%) compared to a control group of 908 patients who received conventional conservation treatment (91.3%) over a median follow-up of 7.2 years.

Although the disease-free survival rate was slightly lower in the oncoplastic group (69% vs. 73.1%), the difference was not statistically significant, indicating that oncoplastic surgery is a safe and effective option for treating invasive breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncological results of oncoplastic breast-conserving surgery: Long term follow-up of a large series at a single institution: A matched-cohort analysis. De Lorenzi, F., Hubner, G., Rotmensz, N., et al.[2022]

In a study involving 5 patients with poorly differentiated non-anaplastic thyroid carcinoma, an intraoperative radiation therapy (IORT) protocol combined with post-operative irradiation resulted in a 100% tumor control rate in the thyroid bed.

No specific complications were reported from the IORT treatment, indicating a favorable safety profile for this approach in managing aggressive thyroid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy in advanced thyroid cancer. Wolf, G., Geyer, E., Langsteger, W., et al.[2019]

In a study of 20 patients with anaplastic thyroid carcinoma (ATC), surgical resection combined with radiotherapy and chemotherapy improved local disease control and resulted in a significant survival advantage compared to a control group, where all patients died within 1 to 13 months.

All patients who underwent surgery preserved the function of at least one laryngeal recurrent nerve, and none experienced permanent hypoparathyroidism, indicating that surgical intervention can be performed with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of anaplastic thyroid carcinoma. Our experience. Palestini, N., Brignardello, E., Freddi, M., et al.[2022]

In a study of 59 female patients undergoing oncoplastic breast reduction, the overall complication rate was 33.9%, which is higher than the rates typically seen with standard breast-conserving surgery.

Increased age and the presence of pulmonary disease were linked to a higher risk of minor complications, indicating that patient selection and counseling are crucial when considering this surgical option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postoperative Complications after Oncoplastic Reduction. Mattingly, AE., Ma, Z., Smith, PD., et al.[2020]

In a study of 119 patients with anaplastic thyroid cancer (ATC) and poorly differentiated thyroid cancer (PDTC) who underwent curative surgery, initial remission was achieved in 84% of patients, with significantly higher rates in differentiated thyroid cancer (DTC) with anaplastic foci (97.8%) and PDTC (96.7%) compared to ATC (60.5%).

The recurrence rates were notably higher in ATC (30.8%) and PDTC (25.9%) compared to DTC with anaplastic foci (6.7%), and overall mortality was highest in ATC at 58.1%, highlighting the need for careful monitoring for distant metastasis in patients with aggressive forms of thyroid cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival After Gross Total Removal of Resectable Undifferentiated or Poorly Differentiated Thyroid Carcinoma. Lee, DY., Won, JK., Choi, HS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12222354/

Intraoperative Radiation Therapy (IORT) for Breast Cancer Two prospective randomized IORT trials, TARGIT-A 1–3 and ELIOT4–6 showed promising results, with acceptable local recurrence rates.

2. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/astro-corrects-media-misinformation-on-breast-cancer-treatment-options

ASTRO corrects media misinformation on breast cancer ... As of now, IORT has not been proven to have the value of other methods of partial breast irradiation. The mission of the ASTRO Breast Resource ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39439951/

Comparative long-term oncological outcomes of ... Conclusion: At a long-term follow-up, the LRR rate was higher in the BCS followed by IORT, without significant differences in metastasis-free or ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468294225000620

Long-term oncologic outcome of intraoperative ... The 5-year loco-regional recurrence-free survival (LRRFS), recurrence-free survival (RFS), and overall survival (OS) rates were 97.37 %, 96.32 %, and 100 %, ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/2024/6207762

Outcomes From Real‐World Data on Intraoperative ... With a median follow-up of 66.6 months, the overall survival and mastectomy-free rates were 95.66% and 90.65%, respectively; this demonstrates ...

6. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.15092

Long‑term follow‑up outcomes of intraoperative ... However, the long‑term outcomes and safety of IORT in patients with breast cancer remain incompletely understood.

7. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-024-01936-0

Intraoperative radiotherapy versus ... - Breast Cancer Research We aimed to compare the outcome of IORT to that of whole-breast external beam radiotherapy (EBRT) in highly selected breast cancer patients.