What is the mechanism of action of this treatment?

Breast cancer treatments encompass a variety of mechanisms aimed at eradicating cancer cells. Surgery physically removes tumors, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers. Targeted therapies, such as monoclonal antibodies, specifically attack cancer cell markers. Radiotherapy uses high-energy radiation to destroy cancer cells. Targeted radiotherapy, like Lutetium-177-DOTAGA-IAC, combines a radioactive isotope with a molecule that specifically binds to cancer cells, delivering radiation directly to the tumor. This precision minimizes damage to surrounding healthy tissue, making it a promising option for patients with advanced or difficult-to-treat breast cancer.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, including targeted radiotherapy like Lutetium-177-DOTAGA-IAC, often have side effects such as nausea, fatigue, and hematologic toxicities (e.g., thrombocytopenia, lymphopenia, anemia, and leukopenia). These side effects are typically due to the irradiation of bone marrow. Other general side effects of breast cancer treatments can include hair loss, skin changes, and gastrointestinal issues. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including chemotherapy, hormone therapy, targeted therapy, and immunotherapy. However, specific approvals for targeted radiotherapy using Lutetium-177 for breast cancer are not well-documented. Broadly, targeted therapies such as trastuzumab (Herceptin) for HER2-positive breast cancer and CDK4/6 inhibitors like palbociclib (Ibrance) have been significant advancements. Radiopharmaceuticals like Lutetium-177 are more commonly associated with neuroendocrine tumors and prostate cancer, as seen with 177Lu-Dotatate and Ra-223. The investigational agent Lutetium-177-DOTAGA-IAC represents a novel approach in the context of breast cancer treatment.

What other types of research exist?

Promising alternatives to Lutetium-177-DOTAGA-IAC for breast cancer treatment include 177Lu-labeled antibodies such as 177Lu-Pan and 177Lu-DOTA-cetuximab, which have shown favorable tumor targeting efficacy and significant tumor growth delay in preclinical models. Additionally, 177Lu-octapa-trastuzumab has demonstrated improved biodistribution and higher tumor-to-tissue activity ratios, making it a potential candidate for further investigation in breast cancer therapy.

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Radioisotope Therapy

Lu-177 for Advanced Breast Cancer (Heroine01 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Advanced Imaging Projects, LLC

Eligibility Criteria Checklist

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

Must have

ECOG score ≤3

Positive scan with PET/CT imaging with Ga-68 αvβ3-IAC PET/CT

Must not have

Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.)

Previously received external beam irradiation to a field that one kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug that uses radiation to target and kill cancer cells in patients with advanced breast cancer who have not responded to other treatments. The goal is to see if this drug can help shrink tumors and improve patients' quality of life.

Who is the study for?

This trial is for women with angiogenic breast cancer that's spread and hasn't been removed by surgery. They must have tried at least one treatment before, be over 18, not pregnant, able to follow the study plan, and have a certain level of physical fitness (ECOG score ≤3). Their organs need to function well enough to handle the trial.

What is being tested?

The trial tests a new drug called Lutetium-177-DOTAGA-PEG-IAC on patients with advanced breast cancer who've had previous treatments. It's an early-phase study looking at safety and effectiveness. Patients will get this drug and then be monitored using PET/CT scans.

What are the potential side effects?

Possible side effects aren't detailed here but may include typical reactions related to radiation-based therapies such as fatigue, nausea, or changes in blood counts due to bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am capable of limited self-care.

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My PET/CT scan showed positive results for a specific test.

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My cancer did not respond to previous treatments including trastuzumab.

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My blood counts and organ functions are within the required ranges.

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My breast tumor is confirmed to grow new blood vessels.

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I am not pregnant or cannot become pregnant.

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I am 18 years old or older.

Exclusion Criteria

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

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I cannot stay still for long periods due to a condition like severe arthritis.

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I have had radiation therapy targeting one of my kidneys.

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I do not have any ongoing infections.

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I do not have any health or mental conditions that could risk my safety or affect the study.

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My kidney function is reduced.

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I have not received any live vaccines in the last 30 days.

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My cancer has only spread to my bones.

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I have had a kidney removal, transplant, or am on medication that could harm my kidneys.

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I've had radiation therapy that affected over 30% of my bone marrow.

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I've had radiation therapy targeting the only known cancer lesion.

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I don't have lasting side effects from cancer treatment, except for hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Specific Aim 2

Specific Aim 3

Specific Aim 4

+1 more

Secondary study objectives

Specific Aim 1

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: Arm 1Experimental Treatment1 Intervention

Single Arm study Lu-177-DOTAGA-IAC (intracutaneous) Dosage and Dose Escalation Frequency: Cohort 1: 75 mCi x 3 (maximum cumulative administered activity, 225mCi) + 100 μgr IAC Cohort 2: 150 mCi x 3 (maximum cumulative administered activity, 450mCi) + 100 μgr IAC Cohort 3: 200 mCi x 3 (maximum cumulative administered activity, 600mCi) + 100 μgr IAC Three cycles each 4 weeks apart.

0 / 18Eligibility 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 encompass a variety of mechanisms aimed at eradicating cancer cells. Surgery physically removes tumors, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers. Targeted therapies, such as monoclonal antibodies, specifically attack cancer cell markers. Radiotherapy uses high-energy radiation to destroy cancer cells. Targeted radiotherapy, like Lutetium-177-DOTAGA-IAC, combines a radioactive isotope with a molecule that specifically binds to cancer cells, delivering radiation directly to the tumor. This precision minimizes damage to surrounding healthy tissue, making it a promising option for patients with advanced or difficult-to-treat breast cancer.

Potential molecular targets for Ewing's sarcoma therapy.Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer.