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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 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.

Heroine01 Trial 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

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 more

Secondary 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.

0 / 7Eligibility criteria met

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

868 Previous Clinical Trials

487,790 Total Patients Enrolled

Postgraduate Institute of Medical and ResearchUNKNOWN

Media Library

Lutetium-177-DOTAGA-PEG-IAC (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04469127 — Phase 1 & 2

Breast Cancer Research Study Groups: Arm 1

Breast Cancer Clinical Trial 2023: Lutetium-177-DOTAGA-PEG-IAC Highlights & Side Effects. Trial Name: NCT04469127 — Phase 1 & 2

Lutetium-177-DOTAGA-PEG-IAC (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469127 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to become a participant in this research?

"Eligibility for this medical investigation requires prospective participants to possess the erbb2 gene and fall within an age range of 18 - 80. A total of 100 individuals are being welcomed into the trial."

Answered by AI

Does this medical trial accept adults aged 25 or younger as participants?

"Eligible participants must fall within the 18–80 age bracket. There are 64 studies catering to minors and 2209 trials geared towards seniors."

Answered by AI

Are there vacancies for participants in this medical research endeavor?

"The clinicaltrials.gov page suggests that this particular research project is not presently enrolling subjects, with the study being first posted on January 30th 2023 and last updated on November 11th 2022. Nonetheless, there are still 2,291 other trials searching for participants at this time."

Answered by AI

Recent research and studies

Bioorganic & Medicinal Chemistry LettersJournal

Synthesis and Characterization of Αvβ3-targeting Peptidomimetic Chelate Conjugates for PET and SPECT Imaging

Kim, Young-Seung, Kido Nwe, Diane E. Milenic, Martin W. Brechbiel, Stanley Satz, and Kwamena E. Baidoo. 2012. “Synthesis and Characterization of Αvβ3-targeting Peptidomimetic Chelate Conjugates for PET and SPECT Imaging”. Bioorganic & Medicinal Chemistry Letters. Elsevier BV. doi:10.1016/j.bmcl.2012.07.024.

Cancer Biotherapy and RadiopharmaceuticalsJournal

First-in-human Study Demonstrating Tumor-angiogenesis by PET/CT Imaging With68ga-nodaga-theranost, a High-affinity Peptidomimetic for Αvβ3integrin Receptor Targeting

Baum, Richard P., Harshad R. Kulkarni, Dirk Müller, Stanley Satz, Narasimhan Danthi, Young-Seung Kim, and Martin W. Brechbiel. 2015. “First-in-human Study Demonstrating Tumor-angiogenesis by PET/CT Imaging With68ga-nodaga-theranost, a High-affinity Peptidomimetic for Αvβ3integrin Receptor Targeting”. Cancer Biotherapy and Radiopharmaceuticals. Mary Ann Liebert Inc. doi:10.1089/cbr.2014.1747.

clinicaltrials.govStudy

A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.

2024. "A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04469127.