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

Trial Summary

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 data supports the effectiveness of the treatment Oncoplastic Surgery + IORT for Breast Cancer?

Intraoperative radiation therapy (IORT) has shown effectiveness in controlling tumors in other types of cancer, such as thyroid cancer, where it helped control the tumor in the thyroid bed in all patients studied. This suggests that IORT could be beneficial in managing breast cancer when combined with oncoplastic surgery. ^{1 2 3 4 5}

Is oncoplastic surgery with IORT safe for breast cancer patients?

Oncoplastic breast surgery, which combines cancer surgery with plastic surgery techniques, is generally considered safe and aims to improve cosmetic outcomes. Studies have shown that it has comparable safety to traditional breast-conserving surgery, with a focus on minimizing complications and achieving good aesthetic results. ^{6 7 8 9 10}

How is the treatment Oncoplastic Surgery + IORT for Breast Cancer different from other treatments?

Oncoplastic surgery combined with intraoperative radiotherapy (IORT) for breast cancer is unique because it integrates immediate breast reconstruction with radiation therapy delivered during surgery, potentially reducing the need for additional radiation sessions and improving cosmetic outcomes compared to traditional breast-conserving surgery. ^{9 10 11 12 13}

What is the purpose of this trial?

Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.

Research Team

Janie G. Weng Grumley

Principal Investigator

Saint John's Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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 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 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 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-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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A case of recurrent malignant phyllodes tumor undergoing nipple-sparing mastectomy with immediate breast reconstruction. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy in advanced thyroid cancer. [2019]

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

Combined treatment of anaplastic thyroid carcinoma with surgery, chemotherapy, and hyperfractionated accelerated external radiotherapy. [2022]

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

Recurrence and Survival After Gross Total Removal of Resectable Undifferentiated or Poorly Differentiated Thyroid Carcinoma. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Surgical treatment of anaplastic thyroid carcinoma. Our experience. [2022]

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

Surgical, oncologic, and cosmetic differences between oncoplastic and nononcoplastic breast conserving surgery in breast cancer patients. [2022]

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

Early Postoperative Complications after Oncoplastic Reduction. [2020]

8. England 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. [2022]

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

The Impact of Oncoplastic Reduction on Initiation of Adjuvant Radiation and Need for Reexcision: A Database Evaluation. [2022]

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

Oncoplastic techniques and tricks to have in your toolbox. [2023]

11. Cyprus pubmed.ncbi.nlm.nih.gov

Efficacy of oncoplastic breast-conserving surgery combined with intraoperative radiotherapy on early breast cancer. [2021]

12. United States 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. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Current practice and provision of oncoplastic breast-conserving surgery in the UK: results of the ANTHEM national practice questionnaire. [2023]