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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights
Heroine01 Trial Summary
This trial is testing a new cancer treatment drug to see if it is effective and safe for people with breast cancer that has spread and cannot be removed with surgery.
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.Check my eligibility
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.See study design
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.
Heroine01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Heroine01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Specific Aim 2
Specific Aim 3
Specific Aim 4
+1 moreSecondary outcome measures
Specific Aim 1
Heroine01 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.
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.
Potential molecular targets for Ewing's sarcoma therapy.Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer.
Find a Location
Who is running the clinical trial?
University of Witwatersrand, South AfricaOTHER
98 Previous Clinical Trials
9,944,236 Total Patients Enrolled
1 Trials studying Breast Cancer
60 Patients Enrolled for Breast Cancer
US Department of Veterans AffairsFED
870 Previous Clinical Trials
495,847 Total Patients Enrolled
Postgraduate Institute of Medical and ResearchUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am capable of limited self-care.I cannot stay still for long periods due to a condition like severe arthritis.I have had radiation therapy targeting one of my kidneys.I do not have any ongoing infections.My PET/CT scan showed positive results for a specific test.My cancer did not respond to previous treatments including trastuzumab.My blood counts and organ functions are within the required ranges.I do not have any health or mental conditions that could risk my safety or affect the study.My breast tumor is confirmed to grow new blood vessels.My kidney function is reduced.I have not received any live vaccines in the last 30 days.My cancer has only spread to my bones.I am not pregnant or cannot become pregnant.You weigh 400 pounds or more and cannot fit into the PET/CT scanner, which could affect the quality of the images.I am 18 years old or older.I have had a kidney removal, transplant, or am on medication that could harm my kidneys.I've had radiation therapy that affected over 30% of my bone marrow.I've had radiation therapy targeting the only known cancer lesion.I have not taken high doses of steroids by IV in the last 8 weeks or more than 20 mg of oral steroids in the last 30 days.I don't have lasting side effects from cancer treatment, except for hair loss.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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