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

Trial Summary

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 data supports the effectiveness of the treatment Partial Mastectomy Methods for Breast Cancer using Savi Scout® localization?

Research shows that the Savi Scout system is an accurate and reliable method for localizing and removing breast lesions, with acceptable rates of needing additional surgery to remove cancerous tissue. It overcomes many limitations of other localization methods, making it a promising option for breast cancer surgery. ^{1 2 3 4 5}

What makes the partial mastectomy with Savi Scout® localization and selective shave margins treatment unique for breast cancer?

This treatment is unique because it uses the Savi Scout® system, which is a radar-based technology, to precisely locate the tumor before surgery, reducing the need for uncomfortable wire localization. Additionally, the use of selective shave margins helps ensure that no cancerous tissue is left behind, potentially lowering the risk of cancer recurrence. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Research Team

Andrew Fenton, M.D.

Principal Investigator

Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Eligibility Criteria

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

I am a man.

Pregnant women

I am under 18 years old.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Beyond Wires and Seeds: Reflector-guided Breast Lesion Localization and Excision. [2018]

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

Implementing the SAVI SCOUT System in Community Radiology Practice. [2018]

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

Savi Scout Radar Localization Versus Wire Localization for Breast Biopsy Regarding Positive Margin, Complication, and Reoperation Rates. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

SAVI SCOUT® localization of metastatic axillary lymph node prior to neoadjuvant chemotherapy for targeted axillary dissection: a pilot study. [2022]

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

Utilization of multiple SAVI SCOUT surgical guidance system reflectors in the same breast: A single-institution feasibility study. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. China pubmed.ncbi.nlm.nih.gov

Ultrasound image-guided core biopsy of the breast. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Intraoperative Ultrasound Guidance With an Ultrasound-Visible Clip: A Practical and Cost-effective Option for Breast Cancer Localization. [2021]

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

A management algorithm and practical oncoplastic surgical techniques for repairing partial mastectomy defects. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Prognostic factors for residual occult disease in shave margins during partial mastectomy. [2021]