Lu-177 for Advanced Breast Cancer

(Heroine01 Trial)

Not yet recruiting at 7 trial locations

Overseen By Rose Satz

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Advanced Imaging Projects, LLC

Must not be taking: Corticosteroids, Investigational agents

Disqualifiers: Renal issues, Bone metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a new treatment called Lutetium-177-DOTAGA-IAC, a type of radiopharmaceutical therapy, for advanced breast cancer that cannot be surgically removed. The treatment will be tested on patients whose cancer has not responded to at least one round of standard chemotherapy. Participants should have breast cancer confirmed as angiogenic (related to blood vessel growth) and must have undergone a specific type of PET/CT scan. The trial seeks individuals willing to comply with study requirements and who have experienced tumor progression despite previous treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have used any other investigational therapeutic product within 30 days prior to dosing or if you require any other investigational agent before completing all scheduled study assessments.

Is there any evidence suggesting that Lutetium-177-DOTAGA-PEG-IAC is likely to be safe for humans?

Research shows that Lutetium-177-DOTAGA-PEG-IAC, a treatment under study for advanced breast cancer, targets and destroys cancer cells using a radioactive substance. This approach differs from traditional treatments. In earlier studies, researchers administered this treatment in cycles, with breaks in between, to assess its safety and tolerability. These studies indicate it has generally been well-tolerated, although some patients experienced side effects. As the treatment remains in early testing stages, researchers continue to gather safety information, but the results so far are promising. However, like any new treatment, risks exist, and it is important to be aware of them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lutetium-177-DOTAGA-PEG-IAC is unique because it uses a targeted radiopharmaceutical approach to treat advanced breast cancer. Unlike standard treatments like chemotherapy and hormone therapy, which affect both cancerous and healthy cells, this treatment delivers radiation directly to cancer cells, minimizing damage to surrounding tissues. Researchers are excited about its potential to provide a more precise and potentially effective option with fewer side effects, offering hope for patients with advanced stages of the disease.

What evidence suggests that Lutetium-177-DOTAGA-PEG-IAC might be an effective treatment for advanced breast cancer?

Research has shown that Lutetium-177-DOTAGA-PEG-IAC uses a radioactive substance called Lutetium-177 to target and destroy cancer cells. This method differs from traditional treatments and shows promise for breast cancer. Early findings suggest that similar treatments with Lutetium-177 are safe and effective for advanced cancers. In studies with other cancer patients, this treatment proved safe and may improve outcomes. While more research is needed, these early results offer encouragement for people with advanced breast cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Stanley Satz, Ph.D.

Principal Investigator

Advanced Imaging Projects

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am capable of limited self-care.

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

The patient is able and willing to provide informed consent and to comply with the requirements of this trial protocol

Exclusion Criteria

Additional inclusion criterion for measure human dosimetry: Unable to comply with the requirements of the dosimetry imaging protocol

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

I have had radiation therapy targeting one of my kidneys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Assessment of safety and adequacy of a dose of HurlutinTM Lu-177 for up to three cycles, at 4-week intervals

12 weeks

3 visits (in-person)

Phase II Treatment

Demonstration of safety, dose adequacy, anti-tumor activity, and efficacy of tumor-targeted therapy using Lutetium-177-DOTAGA-IAC

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lutetium-177-DOTAGA-PEG-IAC

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Advanced Imaging Projects, LLC

Lead Sponsor

Trials

2

Recruited

130+

University of Witwatersrand, South Africa

Collaborator

Trials

107

Recruited

10,090,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Postgraduate Institute of Medical and Research

Collaborator

Trials

1

Recruited

100+

All India Institute of Medical Sciences, New Delhi

Collaborator

Trials

196

Recruited

200,000+

Published Research Related to This Trial

The LUTIA study is a multicenter randomized controlled trial involving 26 patients with unresectable grade I or II neuroendocrine tumors, aiming to compare intra-arterial (IA) administration of 177Lu-DOTATATE to conventional intravenous (IV) administration to enhance tumor-absorbed doses in liver metastases.

The primary goal is to determine if IA treatment leads to a higher tumor-to-non-tumor uptake ratio of 177Lu-DOTATATE in liver metastases, which could potentially improve treatment response and survival rates for patients with bulky liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial). Ebbers, SC., Braat, AJAT., Moelker, A., et al.[2020]

In a study of 38 patients with stage IV neuroendocrine tumors, lutetium-177 (177Lu)-DOTATATE therapy significantly improved global health-related quality of life from the start of treatment to three months after completion.

Patients reported notable reductions in nausea, vomiting, and gastrointestinal symptoms, indicating that 177Lu-DOTATATE therapy not only enhances overall well-being but also alleviates specific disease-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Cohort Real-World Study on Neuroendocrine Tumor Patient's Quality of Life During Peptide Receptor Radionuclide Therapy With 177Lu-DOTATATE. Ramim, JE., Matheos de Lima, BA., Bulzico, DA., et al.[2023]

177Lu-DOTA-Peptide 2, a new radioantagonist, showed high stability and selective binding to somatostatin receptors in HT-29 colorectal cancer cells, indicating its potential for targeted therapy.

The study demonstrated that 177Lu-DOTA-Peptide 2 has a low internalization rate and a high tumor uptake, making it a promising candidate for radionuclide therapy in treating somatostatin receptor-positive tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical study of a new 177Lu-labeled somatostatin receptor antagonist in HT-29 human colorectal cancer cells. Behnammanesh, H., Erfani, M., Hajiramezanali, M., et al.[2023]

Lutetium Lu-177 dotatate is an effective treatment for gastroenteropancreatic neuroendocrine tumors, significantly improving progression-free survival, as shown in European studies.

In a study of 12 patients, tumor flare reactions were observed in 5 patients, but these reactions can be effectively managed with corticosteroids or other strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutetium Lu-177 Dotatate Flare Reaction. Salner, AL., Blankenship, B., Dunnack, H., et al.[2022]

In a study of 79 patients with progressive neuroendocrine tumors treated with Lu-DOTATATE, 13% showed a partial response and 64% had stable disease, with a median time to progression of 28 months overall.

The treatment was found to be safe, with only a few patients experiencing mild toxicity, including grade 1 haematotoxicity and nephrotoxicity, supporting its use as an effective option for managing these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early efficacy of and toxicity from lutetium-177-DOTATATE treatment in patients with progressive metastatic NET. Pencharz, D., Walker, M., Yalchin, M., et al.[2019]

In a study of 47 patients with progressive well-differentiated neuroendocrine tumors (NETs) treated with 177Lu-Dotatate, the median progression-free survival was 34.1 months, indicating the treatment's efficacy in managing these tumors over time.

Factors such as having 5 or more bone metastases, non-gastroenteropancreatic NETs, high levels of chromogranin A, and pre-existing ascites were identified as significant predictors of poorer overall survival, helping to identify patients who may benefit less from this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival predictors of 177Lu-Dotatate peptide receptor radionuclide therapy (PRRT) in patients with progressive well-differentiated neuroendocrine tumors (NETS). Swiha, MM., Sutherland, DEK., Sistani, G., et al.[2022]

Lutetium-177 (Lu-177) DOTATATE is an effective treatment for inoperable gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have not responded to standard therapies, as it can reduce tumor size, improve symptoms, and increase progression-free survival.

The practice parameter document ensures safe handling and administration of Lu-177 DOTATATE, providing essential guidelines for authorized users to maintain consistent and safe treatment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR-ACNM-ASTRO-SNMMI Practice Parameter for Lutetium-177 (Lu-177) DOTATATE Therapy. Love, C., Desai, NB., Abraham, T., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04469127

NCT04469127 | A Phase I/II Multicenter, Open-Label Study ... This study is a Phase I/II clinical evaluation of a new investigational agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to treat patients with ...

2. withpower.com withpower.com/trial/lu-177-for-advanced-breast-cancer-c28c5

Lu-177 for Advanced Breast Cancer (Heroine01 Trial) Lu-177-DOTAGA-PEG-IAC is unique because it uses a radioactive substance, Lutetium-177, to target and destroy cancer cells, which is different from traditional ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37932560/

Therapeutic potential of [177Lu]Lu-DOTAGA-FAPi dimers ... The findings suggest that [ 177 Lu]Lu-DOTAGA.FAPi dimer therapy is well-tolerated, safe, and effective for treating end-stage metastatic breast cancer patients.

4. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT04469127/

Trial | NCT04469127 This study is a Phase I/II clinical evaluation of a new investigational agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to treat patients with ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-breast-cancer-stage-iv-ii-multicenter-open-label-lu-177-v-3-trial-nct04469127

A Phase I/II study of Lu-177-DOTAGA-IAC in angiogenic ... Participation in this study offers the opportunity to receive a potentially effective investigational treatment for advanced breast cancer. The study may ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/247367

A Phase I/II Multicenter, Open-Label Study of Lu-177- ... To determine the safety and tolerability of fractionated administrations of 3 cycles of Lu-177-DOTAGA-IAC administered with 4 weeks between cycles in patients ...

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-lutetium-lu-177-and-aby-271-in-patients-with-her2-positive-metastatic-breast-cancer/

Study on the Safety and Effects of Lutetium Lu-177 and ... This study examines the safety and effects of Lutetium Lu-177 and ABY-271 in treating patients with HER2-positive metastatic breast cancer.