What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as lumpectomy, chemotherapy, and endocrine therapy, have various side effects. Lumpectomy can lead to pain, infection, and changes in breast shape. Chemotherapy often causes hair loss, nausea, fatigue, and increased risk of infection. Endocrine therapies, like tamoxifen and aromatase inhibitors, can result in hot flashes, bone density loss, and cardiovascular risks. Laser ablation, as studied in the Novilase trial, aims to minimize these side effects by focusing on the focal destruction of tumors, potentially reducing the need for more invasive procedures.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including surgical options like lumpectomy and mastectomy, systemic therapies such as chemotherapy, hormone therapy, and targeted therapies like HER2 inhibitors (e.g., trastuzumab). While Novilase's laser ablation therapy is a newer, minimally invasive approach under investigation, other focal treatments like cryoablation and radiofrequency ablation have also been explored, though they are less commonly used compared to traditional surgical and systemic treatments.

What other types of research exist?

Promising novel alternatives to Novilase for breast cancer treatment include: 1) Immunotherapy, such as pembrolizumab, which has shown effectiveness in certain subtypes of breast cancer. 2) PARP inhibitors like olaparib, particularly for patients with BRCA mutations. 3) Antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan, which target specific cancer cells while minimizing damage to normal cells. 4) Targeted therapies like CDK4/6 inhibitors (e.g., palbociclib) for hormone receptor-positive breast cancer. These options should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Laser Therapy

Novilase Laser Therapy for Breast Cancer

N/A

Recruiting

Led By Barbara Schwartzberg, MD

Research Sponsored by Novian Health Inc.

Eligibility Criteria Checklist

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

Must have

Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images)

Subject weight limited to ≤300 lbs. or ≤136 kg

Must not have

Subject who is known to be BRCA positive

Tumor that is ER/PR/HER2 negative (TNBC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a laser treatment called Novilase to destroy small breast cancer tumors. It targets patients with tumors 15 mm or smaller, aiming to offer a less invasive option than surgery. The laser works by heating and killing the cancer cells.

Who is the study for?

This trial is for women aged 18+ with breast tumors no larger than 15mm, visible on MRI or mammography, and at least 5mm from the skin/chest wall. Participants must not have severe chronic illnesses, be pregnant/breastfeeding, have certain allergies to contrast agents or metals, kidney disease, extensive intraductal components (>25%), or known BRCA positivity.

What is being tested?

The Novilase Laser ablation technique is being tested for its ability to destroy malignant breast tumors up to 15mm in size. It's compared against lumpectomy standards aiming for less than a 20% retreatment rate. The procedure's success was previously indicated by a feasibility study.

What are the potential side effects?

Potential side effects of Novilase Laser ablation may include discomfort at the treatment site, bruising or swelling post-procedure, changes in skin sensation near the treated area and risks associated with laser treatments such as burns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My tumor can be clearly seen and distinguished from surrounding tissues on an ultrasound or mammogram.

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I weigh 300 lbs (136 kg) or less.

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My cancer is a single, small tumor not touching my skin or chest wall.

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I don't have any major health issues besides my cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have tested positive for the BRCA gene mutation.

Select...

My breast cancer is triple-negative.

Select...

I cannot have gadolinium contrast due to a past allergic reaction or severe kidney issues.

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My tumor is larger than 15 mm in its biggest size.

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My tumor is not a common breast cancer type.

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My tumor is mostly non-invasive but has a tiny area that has started to spread.

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I cannot lie on my stomach or back for an hour.

Select...

I haven't had a definitive HER2 test as per medical guidelines.

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I am under 18 years old.

Select...

My breast cancer is in an advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery

Percentage of target tumors completely ablated in one procedure

Secondary study objectives

Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)

Patient reported rate of return to activities of daily living post-laser ablation and post-surgery

Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)

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: Novilase Laser Ablation and excisionExperimental Treatment1 Intervention

Eligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care.

0 / 14Eligibility criteria met

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. Hormonal therapies, such as tamoxifen, block estrogen receptors on cancer cells, slowing their growth. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, by damaging their DNA or interfering with cell division. Laser ablation, like Novilase, uses focused laser energy to heat and destroy cancerous tissue precisely, minimizing damage to surrounding healthy tissue. These treatments are crucial for breast cancer patients as they offer multiple strategies to combat the disease, potentially improving survival rates and quality of life by targeting cancer cells through different pathways.

Adjuvant hormonal therapy in premenopausal women with operable breast cancer: not-so-peripheral perspectives.Adjuvant therapy of breast cancer: update.