What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy, each have distinct side effects. Chemotherapy can cause hair loss, nausea, fatigue, and infection risk. Radiation therapy may lead to skin irritation and fatigue. Hormone therapies like tamoxifen can cause hot flashes and blood clots. Targeted therapies, such as trastuzumab, can result in cardiac issues. Surgical procedures, relevant to the LS301-IT trial, may cause pain, infection, and lymphedema.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including hormone therapies, chemotherapy, targeted therapies, and immunotherapies. While specific fluorescence imaging agents like LS301-IT are still under investigation, other imaging agents such as technetium-99m sestamibi and fluorodeoxyglucose (FDG) used in PET scans have been approved for diagnostic purposes in breast cancer. These imaging agents help in detecting and monitoring the disease, guiding treatment decisions. Additionally, drugs like trastuzumab (Herceptin) and pertuzumab (Perjeta) have been approved for targeted therapy in HER2-positive breast cancer, significantly improving patient outcomes.

What other types of research exist?

Promising alternatives to LS301-IT for breast cancer patients include autofluorescence laparoscopy, which has been shown to detect peritoneal endometriotic lesions, and narrowband imaging, which has improved the identification of superficial endometriosis. Additionally, integrin α2β1-targeted self-assembled nanocarriers (ITNC OF27) for tumor bioimaging and luminescence-based interventional molecular imaging technologies are innovative options that could be considered.

← Back to Search

LS301 Imaging Agent for Breast Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Integro Theranostics

Eligibility Criteria Checklist

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

Must have

DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy.

ECOG performance status of 0 to 2

Must not have

Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1.

Simultaneous bilateral lumpectomies and bilateral partial mastectomies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special dye called LS301-IT that helps surgeons see breast cancer cells more clearly during surgery. It targets women with early-stage breast cancer undergoing partial mastectomy. The dye makes cancer cells glow under a special light, aiding in more precise removal.

Who is the study for?

This trial is for women having partial mastectomy for DCIS or Stage I-II primary invasive breast cancer, including those planning SLNB. Participants should be in good general health with an ECOG performance status of 0 to 2. It's not suitable for those who've had recent breast surgery, chest radiation therapy, prior cancer treatments for the current diagnosis, or severe drug allergies.

What is being tested?

The study tests different doses of LS301-IT, a new imaging agent given by IV before surgery to see how safe and effective it is at highlighting cancerous tissue during partial mastectomy and SLNB procedures in patients with certain types of breast cancer.

What are the potential side effects?

Potential side effects are not detailed but may include reactions similar to other agents used in the study such as indocyanine green (ICG), which can cause allergic reactions. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have early-stage breast cancer and am having or had a partial mastectomy.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

Select...

I have had chemotherapy, hormone therapy, or biological therapy for my current breast cancer.

Select...

I have had lumpectomies or partial mastectomies on both breasts.

Select...

I cannot undergo surgery due to health risks.

Select...

I have had radiation therapy to my chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AUCinf

AUClast

Adverse Events

+4 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: LS301-ITExperimental Treatment4 Interventions

LS301-IT will be administered by IV injection

0 / 6Eligibility 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

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves the physical removal of the tumor, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Radiation therapy employs high-energy rays to destroy cancer cells. Hormone therapy blocks hormones like estrogen that fuel certain types of breast cancer, and targeted therapy uses drugs to target specific molecules involved in cancer growth and spread. Fluorescence imaging agents, such as LS301-IT, are being studied to improve the precision of surgical removal of tumors by highlighting cancerous tissues, which can lead to better outcomes and fewer recurrences. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan tailored to the individual's cancer type and stage.

Potential molecular targets for Ewing's sarcoma therapy.Indications and limitations of third-generation aromatase inhibitors.Endocrine therapy for early breast cancer.