Partial Mastectomy Methods for Breast Cancer

Recruiting at 1 trial location

Overseen By Wendy Catchpole

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Men, Pregnant, Neoadjuvant chemotherapy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of performing partial mastectomies for breast cancer. The aim is to determine which method more effectively removes cancer while minimizing additional surgery. Both methods use the Savi Scout® tool to locate the cancer, but they differ in the amount of surrounding tissue removed. Women diagnosed with early-stage breast cancer, specifically Stage I-II invasive breast cancer or Stage 0 ductal carcinoma in situ, who have not received chemotherapy, may be suitable candidates. Participants must be able to visit Cleveland Clinic Akron General for treatment. As an unphased trial, this study allows participants to contribute to innovative surgical research that could enhance future breast cancer treatments.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients may have received or may be receiving endocrine therapy, suggesting that some medications might be allowed.

What prior data suggests that these partial mastectomy methods are safe?

Research has shown that the SAVI SCOUT® system in breast surgeries is generally safe and well-tolerated. Studies have found that it helps doctors locate tumors more accurately, leading to more successful surgeries. This system also reduces delays, keeping surgeries on schedule.

In one study, the SAVI SCOUT® method yielded positive results, with very few patients needing another surgery to remove remaining cancerous tissue. Specifically, only about 5.6% of patients had cancer cells at the edge of the removed tissue, and only 5.3% required another surgery.

Overall, the SAVI SCOUT® method for partial mastectomy is considered safe, with few complications reported. Using selective or routine cavity shave margins does not significantly affect safety, but it might change how much tissue is removed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these partial mastectomy methods because they aim to improve precision and outcomes in breast cancer surgery. The use of the Savi Scout® localization technology allows surgeons to accurately locate and remove tumors with minimal disruption to surrounding tissue. Additionally, comparing routine cavity shave margins with selective shave margins could help identify the best technique for reducing the chance of cancer recurrence. These methods could lead to more personalized and effective surgical approaches, offering hope for better recovery and long-term results for patients.

What evidence suggests that this trial's methods could be effective for breast cancer?

Research has shown that Savi Scout® localization effectively finds breast tumors that can't be felt by touch. It improves surgical accuracy compared to older methods like wire-guided localization. Studies have found that Savi Scout® can make surgeries more efficient and reduce operating room delays. In this trial, participants will undergo partial mastectomy with Savi Scout® localization using either routine cavity shave margins or selective shave margins. Early findings suggest both methods may remove cancer at similar rates while possibly preserving more healthy tissue. This can help maintain a more natural breast appearance and lower the chance of needing additional surgeries. ^{1 2 3 5 6}

Who Is on the Research Team?

Andrew Fenton, M.D.

Principal Investigator

Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with early-stage breast cancer (stage I-II) or stage 0 DCIS, diagnosed via core needle biopsy and suitable for breast-conserving therapy. Participants must be patients at Cleveland Clinic Akron General.

Inclusion Criteria

Subjects must have the ability to understand and the willingness to sign a written informed consent document

I have been diagnosed with breast cancer or ductal carcinoma in situ.

I am a woman aged 18 or older.

Exclusion Criteria

Pregnant women

I am a man.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo partial mastectomy with Savi Scout® localization and either routine or selective cavity shave margins

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including completion of the Breast-Q® questionnaire

24 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Partial mastectomy with Savi Scout® localization and selective shave margins
• Partial mastectomy with Savi Scout® localization and shave margins

Trial Overview The study compares two surgical techniques in partial mastectomy: one uses routine cavity shave margins with Savi Scout® localization, while the other uses selective shave margins with the same localization tool. The goal is to see which method results in fewer positive margin rates and less tissue removal without increasing re-surgery needs.

How Is the Trial Designed?

Group I: Arm 1 Active Control 1 Intervention

Partial mastectomy with Savi Scout® localization and routine cavity shave margins

Group II: Arm 2 Active Control 1 Intervention

Partial mastectomy with Savi Scout® localization and selective shave margins.

Partial mastectomy with Savi Scout® localization and selective shave margins is already approved in United States, European Union for the following indications:

Approved in United States as Savi Scout for:

• Breast cancer
• Partial mastectomy guidance

Approved in European Union as Savi Scout for:

• Breast cancer
• Partial mastectomy guidance

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Cleveland Clinic Akron General

Lead Sponsor

Trials

8

Recruited

480+

Published Research Related to This Trial

A management algorithm for repairing partial mastectomy defects helps clinicians choose the best surgical approach based on factors like breast size, timing of reconstruction, and tumor margin status, optimizing patient outcomes.

Immediate repair using local tissue techniques is preferred for medium to large breasts, as it simplifies the procedure and preserves the breast's appearance, while delaying repair after radiation can complicate reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A management algorithm and practical oncoplastic surgical techniques for repairing partial mastectomy defects. Kronowitz, SJ., Kuerer, HM., Buchholz, TA., et al.[2023]

Using ultrasound-visible clips (UVCs) during breast biopsies significantly increased the use of ultrasound localization during partial mastectomy by 13%, indicating that UVCs enhance the effectiveness of ultrasound guidance.

The study found that using UVCs not only avoids the discomfort associated with wire localization but also resulted in cost savings of $36,000 for the institution, making it a recommended practice for breast cancer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Ultrasound Guidance With an Ultrasound-Visible Clip: A Practical and Cost-effective Option for Breast Cancer Localization. Konen, J., Murphy, S., Berkman, A., et al.[2021]

In a study of 166 patients with invasive breast carcinoma and ductal carcinoma in situ (DCIS), 24.5% of those with invasive carcinoma and 29.6% with DCIS had residual occult disease (ROD) after lumpectomy with shave margins, indicating that ROD is a common issue in these surgeries.

A positive initial lumpectomy margin was identified as a significant predictor of ROD, suggesting that surgeons should be cautious and consider broader shave margins during re-excision to minimize the risk of residual disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factors for residual occult disease in shave margins during partial mastectomy. Siegel, JB., Mukherjee, R., Park, Y., et al.[2021]

The SAVI SCOUT Surgical Guidance System is a safe and effective alternative to traditional wire localization for breast surgery, as demonstrated in a study of 183 patients where all lesions were successfully targeted and retrieved.

Using multiple reflectors in the same breast for localization of multiple lesions or large lesions is feasible, with no reported complications and a low rate of positive margins (10.3%) in malignant cases, indicating effective surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of multiple SAVI SCOUT surgical guidance system reflectors in the same breast: A single-institution feasibility study. Jadeja, PH., Mango, V., Patel, S., et al.[2019]

In a study of 512 patients, the Savi Scout localization system showed a significantly lower rate of positive margins (5.6%) and reoperations (5.3%) compared to wire localization, which had rates of 13.7% for reoperations.

The Savi Scout system also resulted in fewer surgical site occurrences (2.1%) compared to wire localization (7.4%), suggesting it may be a safer and more effective option for breast lesion removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Savi Scout Radar Localization Versus Wire Localization for Breast Biopsy Regarding Positive Margin, Complication, and Reoperation Rates. Tingen, JS., McKinley, BP., Rinkliff, JM., et al.[2020]

Using the SAVI SCOUT® reflector to localize metastatic lymph nodes before neoadjuvant chemotherapy (NAC) was successful in 92% of patients, allowing for targeted axillary dissection (TAD) after treatment.

All patients who underwent TAD had the SAVI reflector successfully retrieved, demonstrating that this method may offer advantages in accurately locating lymph nodes compared to traditional post-NAC localization techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAVI SCOUT® localization of metastatic axillary lymph node prior to neoadjuvant chemotherapy for targeted axillary dissection: a pilot study. Baker, JL., Haji, F., Kusske, AM., et al.[2022]

Partial mastectomy, which includes procedures like lumpectomy and wide excision, is effective for tumors smaller than 4 cm, and ensuring clear resection margins can significantly reduce the risk of local recurrence.

This surgical approach offers psychological benefits for patients, but it requires careful execution to prevent unacceptable changes in breast shape, and axillary dissection should be performed through a separate incision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Techniques of breast-conserving therapy in breast carcinoma]. Mosny, D.[2008]

Preoperative diagnosis significantly improves the outcomes of partial mastectomy or lumpectomy, particularly in achieving negative margins, which is crucial for cancer treatment.

Ultrasound (US) is highlighted as a useful and effective tool in the preoperative diagnosis process, aiding in better surgical results and potentially reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound image-guided core biopsy of the breast. Klimberg, VS., Rivere, A.[2017]

The Savi Scout system successfully localized and excised 100% of breast lesions in a study of 100 women, demonstrating its accuracy and reliability in guiding surgical procedures.

The re-excision rate for malignant cases was low at 7.4%, indicating that the method provides acceptable margin positivity, which is crucial for effective cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision. Mango, VL., Wynn, RT., Feldman, S., et al.[2018]

SAVI SCOUT is an FDA-approved localization system designed to assist surgeons in accurately excising nonpalpable breast lesions, improving surgical outcomes.

The article outlines essential technical and clinical considerations for radiologists to effectively implement SAVI SCOUT in community practice, ensuring its successful integration into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the SAVI SCOUT System in Community Radiology Practice. Kalambo, M., Parikh, JR.[2018]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06800

Routine Cavity Shave Margins or Selective ... Selective shave margins using Savi Scout may decrease the volume of tissue removed with no change in positive margin rate compared to routine cavity shave ...

2. withpower.com withpower.com/trial/phase-breast-neoplasms-4-2023-03463

Partial Mastectomy Methods for Breast Cancer This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy ...

3. link.springer.com link.springer.com/article/10.1007/s12609-022-00450-6

Intraoperative Margin Trials in Breast Cancer This paper reviews the literature on current strategies and intraoperative clinical trials to reduce positive margin rates.

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/458135

Breast Margin Study: Routine Cavity Shave Margins Vs ... This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05825482

NCT05825482 | Breast Margin Study: Routine Cavity ... This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10731028/

Locoregional Therapy: From Mastectomy to Reconstruction ... Radical mastectomy has been replaced by breast-conserving and oncoplastic approaches in most patients, and full axillary lymph node dissection by less radical ...