What is the mechanism of action of this treatment?

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Hormone therapy, such as the use of aromatase inhibitors, blocks hormones like estrogen that fuel certain types of breast cancer. Chemotherapy uses drugs to kill rapidly dividing cancer cells throughout the body. Targeted therapy, including CDK4/6 inhibitors, specifically targets molecules involved in cancer cell growth and survival. Immunotherapy, such as anti-PD-1 or anti-CTLA-4 antibodies, helps the immune system recognize and attack cancer cells. These treatments are crucial for breast cancer patients as they offer multiple strategies to combat the disease, often in combination with minimally invasive surgeries like those facilitated by the da-Vinci Single Port Robotic Platform, which can improve recovery times and reduce surgical risks.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, including minimally invasive surgeries like nipple-sparing mastectomy and immediate breast reconstruction, often result in side effects such as pain, infection, and changes in breast sensation. Systemic treatments like chemotherapy can cause weakness, fatigue, nausea, hair loss, and neuropathy. Radiation therapy may lead to skin irritation, fatigue, and lymphedema. Endocrine therapies, such as tamoxifen, can cause hot flashes, vaginal dryness, and an increased risk of blood clots. Aromatase inhibitors may lead to bone density loss and cardiovascular risks.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that align with minimally invasive surgical techniques, such as those facilitated by the da-Vinci Single Port Robotic Platform. Robotic-assisted surgeries, including nipple-sparing mastectomies, have been shown to be safe and feasible, with outcomes comparable to traditional open surgeries. Additionally, drugs like hormone therapies (e.g., tamoxifen, aromatase inhibitors) and targeted therapies (e.g., trastuzumab for HER2-positive breast cancer) are often used in conjunction with surgical treatments to improve patient outcomes. These advancements reflect a trend towards less invasive procedures with enhanced precision and patient satisfaction.

What other types of research exist?

Promising alternatives to the da-Vinci Single Port Robotic Platform for breast cancer patients include: 1) Advanced laparoscopic systems with enhanced 3D imaging and precision tools, 2) Transoral robotic surgery (TORS) adapted for breast surgery, 3) Single-incision laparoscopic surgery (SILS) with improved ergonomic instruments, and 4) Radiofrequency ablation techniques for tumor removal. These alternatives aim to provide minimally invasive options with potential benefits in recovery time, surgical precision, and patient outcomes.

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Procedure

Robotic Nipple-Sparing Mastectomy for Breast Cancer

N/A

Recruiting

Led By Deborah Farr, MD, FACS

Research Sponsored by Deborah Farr, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following surgery up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a robotic system to perform nipple-sparing mastectomy and immediate breast reconstruction. It targets patients with breast cancer or those at high risk. The robot allows precise surgery through a small incision, potentially improving recovery and satisfaction. The robotic system has been used for this type of surgery since its introduction, showing favorable outcomes in terms of cosmetic results and patient satisfaction.

Who is the study for?

This trial is for individuals with breast cancer or at high risk of it, who are fit enough for surgery (good performance status) and candidates for nipple sparing mastectomy. It excludes those with severe nipple sagging, skin tumor involvement, contraindications to anesthesia/surgery, heavy smokers, NAC tumor diagnosis, inability to consent, and pregnant/nursing women.

What is being tested?

The study tests the safety and feasibility of using a robotic system called da Vinci SP for performing nipple sparing mastectomies followed by immediate reconstruction. The goal is to compare this method's outcomes in terms of safety and patient satisfaction against traditional open surgeries.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include reactions to anesthesia, infection from surgery, complications from implant materials like ADM used in reconstruction (Alloderm), pain or changes in sensation around the operated area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following surgery up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following surgery up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and following surgery up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of perioperative complications

Number of participants who complete single port nipple sparing mastectomy (SPrNSM)

Secondary study objectives

Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline

Incidence of long term complications

Incidence of short term complications

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment arm (SPrNSM)Experimental Treatment1 Intervention

Patients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Hormone therapy, such as the use of aromatase inhibitors, blocks hormones like estrogen that fuel certain types of breast cancer. Chemotherapy uses drugs to kill rapidly dividing cancer cells throughout the body. Targeted therapy, including CDK4/6 inhibitors, specifically targets molecules involved in cancer cell growth and survival. Immunotherapy, such as anti-PD-1 or anti-CTLA-4 antibodies, helps the immune system recognize and attack cancer cells. These treatments are crucial for breast cancer patients as they offer multiple strategies to combat the disease, often in combination with minimally invasive surgeries like those facilitated by the da-Vinci Single Port Robotic Platform, which can improve recovery times and reduce surgical risks.

Role of CDK4/6 inhibitors in patients with hormone receptor (HR)-positive, human epidermal receptor-2 negative (HER-2) metastatic breast cancer study protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.