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Safety and Tolerability of Lutetium‑177 Vipivotide Tetraxetan Combined with Gozetotide in Women with Metastatic Triple‑Negative Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Metastatic triple‑negative breast cancer is a form of breast cancer that has spread beyond the breast and lacks three common receptors, making it more difficult to treat with hormone‑based or HER2‑targeted medicines. The study uses an intravenous injection of Pluvicto, a therapy that carries the radioactive element lutetium‑177 attached to a molecule that seeks out cancer cells, a technique known as radioligand therapy. This approach delivers radiation directly to the tumor while limiting exposure to healthy tissue.

The purpose of the study is to establish a safe and tolerable dose for future research. Participants receive the injection in a clinic setting, remain under observation for a short period to watch for immediate reactions, and then return for regular follow‑up visits over several months. During these visits, doctors check for side effects, record any new health problems, and perform simple tests to see how the body processes the radiation.

This early‑stage (phase 1) trial is open‑label, meaning the treatment being given is known to both the medical team and the participants. Safety monitoring includes routine blood work, imaging to look at the spread of disease, and assessments of overall well‑being, all aimed at determining whether the therapy can be given safely at the studied dose.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
After joining the study, a series of baseline tests are performed. these include a review of medical history, physical examination, blood tests, and imaging studies to confirm the presence of metastatic triple negative breast cancer.
The purpose of these assessments is to establish a reference point for evaluating safety and any changes that may occur during the trial.
Step 2
Radiopharmaceutical preparation
The study medication is prepared by combining Locametz (a kit containing 259 MBq of gozetotide) with Pluvicto solution.
The resulting radiopharmaceutical is ready for intravenous administration.
Step 3
Intravenous infusion of study drug
The prepared radiopharmaceutical is given by intravenous infusion (injection into a vein).
The dose of Pluvicto is recorded as 00 GBq (gigabecquerel) as specified in the protocol.
The infusion is performed in a clinical setting and typically lasts only a short period; exact infusion time is determined by the treating team.
Step 4
Immediate post‑infusion monitoring
After the infusion, vital signs and any immediate reactions are monitored for several hours.
Staff observe for signs of discomfort, allergic reaction, or other unexpected effects.
Step 5
Dose‑limiting toxicity observation period
Following the infusion, the patient enters a defined observation period during which the occurrence of dose‑limiting toxicities (DLTs) is recorded.
Any serious side effects that meet the study’s criteria for DLT are documented and reported.
Step 6
Regular follow‑up visits
Scheduled visits are held at intervals established by the protocol to assess safety and tolerability.
Each visit includes a physical exam, blood tests, and imaging as needed to check for treatment‑emergent adverse events (TEAEs).
The frequency of these visits follows the study schedule, which may be weekly or monthly depending on the protocol.
Step 7
Final safety evaluation
At the end of the trial period, a comprehensive safety evaluation is performed.
All recorded adverse events, laboratory results, and imaging findings are reviewed to determine the overall safety profile of the therapy.

Who can join the trial?

22 criteria

Must be a woman who is 18 years of age or older.
Must have waited at least 4 weeks (or five drug half‑lives, whichever is longer) since the last cancer treatment.
Any side effects from earlier treatments must have improved to a severity of grade 3 or less, using the CTCAE (a system that rates how strong side effects are).
Any major surgery must have taken place at least 12 weeks before joining the study.
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Must have adequate blood and organ function, shown by lab tests:
- Platelets ≥ 100 × 10⁹/L
- White blood cells (WBC) ≥ 2.5 × 10⁹/L
- Neutrophils ≥ 1.0 × 10⁹/L
- Hemoglobin ≥ 9 g/dL
- eGFR (a measure of kidney function) ≥ 50 ml/min/1.73 m²
- Bilirubin < 1.5 × Upper Limit of Normal (ULN)
- AST/ALT (liver enzymes) < 3 × ULN
- Albumin ≥ 30 g/L
- Must sign a written informed consent form before any study procedures begin.
- Must agree to follow any lifestyle restrictions required after receiving the study drug.
- Doctor must expect the patient to have a life expectancy of at least 24 weeks (about 6 months) from the start of the study.
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  Must have a confirmed diagnosis of triple‑negative breast cancer that is:
  - HER‑2 negative (tested by IHC 0 or 1+ or FISH negative)
  - Estrogen‑receptor (ER) less than 1 %
  - Progesterone‑receptor (PR) less than 1 %
  - Must have cancer that has returned locally or spread (metastatic) and must have received at least two prior treatment regimens, with the disease getting worse or being intolerable to the most recent therapy; any suitable antibody‑drug conjugates (ADCs) should have been tried if possible.
  - Must have an ECOG performance status of 0‑2 (a scale that measures how well you can perform daily activities).
  - Must have measurable disease (target or non‑target lesions) seen on a recent CT scan, MRI, or bone scan performed within the last 6 weeks.
  - Must have cancer that shows positive PSMA expression on a PSMA PET/CT scan, meaning at least one PSMA‑positive lesion of any size with higher uptake than the blood pool, measured by a value called SUV.

Who cannot join the trial?

23 criteria

Not willing to use reliable birth control methods.
Has a known history of central nervous system (CNS) metastases (cancer spread to the brain or spinal cord), unless it was treated, is stable, causes no symptoms, and does not require steroids or seizure medicines; brain imaging must be done.
Has another solid cancer that could shorten life expectancy or interfere with study assessments, unless it was treated, confirmed by pathology, and the person has been cancer‑free for more than 3 years (treated non‑melanoma skin cancer and non‑muscle invasive bladder cancer are allowed).
Has an unresolved blockage of the urinary tract shown by swelling of the kidney (hydronephrosis) with or without a stent, unless doctors judge the swelling is not actually blocking urine flow and kidney function meets study requirements.
Has any uncontrolled serious medical, mental health, or surgical problem, or abnormal lab result that could put safety at risk; for heart issues this includes severe heart failure (New York Heart Association class III or IV), a genetic condition causing a prolonged QT interval (QT syndrome), or a heart attack (myocardial infarction) within the past 6 months.
Is currently taking bone‑targeting medicines called bisphosphonates, unless a stable dose of zoledronic acid has been used for at least 8 weeks and kidney function (eGFR) is 60 mL/min or higher.
Has severe urinary leakage that would make it unsafe to handle radioactive urine.
Has only one kidney, a kidney transplant, or is on medicines that can damage the kidneys (nephrotoxic therapy) as judged by the investigator.
Shows important abnormalities on a 12‑lead heart tracing (electrocardiogram (ECG)) at screening.
Has had external radiation that covered more than 30 % of the bone marrow or kidneys (external beam irradiation).
Is an employee of the study sponsor, a study site staff member, or an immediate family member (spouse, parent, child, or sibling).
Received an experimental drug in another trial within the last 30 days.
Previously received any of the following radioactive bone treatments: PSMA‑targeted radionuclide therapy, Strontium‑89, Samarium‑153, Rhenium‑186, Rhenium‑188, Radium‑223, or hemi‑body irradiation.
Has both hip joints replaced or other large metal implants that could affect image quality or dose calculations.
Needs a blood transfusion solely to meet the study’s entry requirements.
Is pregnant or breastfeeding.
Is participating in another interventional clinical trial at the same time.
Is confined in a prison or other institutional setting by official or court order.
Has a known allergy (hypersensitivity) to the study drug or its diagnostic partner.
Has cancer that does not show the target molecule (PSMA‑negative disease) as defined by specific imaging rules.
Shows a “superscan” on a bone scan, meaning the entire skeleton lights up and other organs appear very dark, indicating widespread bone marrow disease.
Has symptoms or imaging suggesting spinal cord compression or a high risk of it.
Has a history of blood‑forming (hematological) cancers.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Universitaetsklinikum Aachen AöR
Aachen, Germany
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Universitaetsklinikum Duesseldorf AöR
Duesseldorf, Germany

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Investigated drugs

Pluvicto
is a radioactive medication that is given by injection into a vein. It contains a special form of the element lutetium that is attached to a molecule designed to seek out and bind to cancer cells. In this trial, the drug is being tested to see if it can safely deliver radiation directly to metastatic triple‑negative breast cancer cells, helping to shrink or control the tumors while limiting damage to normal tissue.
Locametz
is a kit used to prepare a radiopharmaceutical for injection. It provides the substance gozetotide, which is combined with the radioactive component to create the final treatment product. In the study, this kit is used in the background to help produce the radioactive drug that participants receive, ensuring the medication is ready for safe administration.

What is already known about the treatment

Pluvicto 1 000 MBq/mL solution for injection/infusion
The drug is supplied as a clear liquid that is given by intravenous injection (IV infusion). It is an approved radiopharmaceutical for treating prostate cancer and is now being studied in a trial for metastatic triple‑negative breast cancer. The active component, lutetium‑177 vipivotide tetraxetan, binds to a protein on cancer cells and delivers a small amount of radiation that destroys those cells. It belongs to the class of beta‑emitting radioligand therapies.
Locametz 25 micrograms kit for radiopharmaceutical preparation
This kit is mixed to create a solution that is injected into a vein (IV injection). Gozetotide is already used in medical literature as a diagnostic radiopharmaceutical that helps image cancers expressing a specific surface protein, and it serves as a background agent in this study. The molecule attaches to the same protein on tumor cells, allowing a tiny radioactive tag to highlight the tumors on scans. It is classified as a radiopharmaceutical imaging agent.

Investigated diseases

Metastatic triple‑negative breast cancer - Metastatic triple‑negative breast cancer is a type of breast cancer that lacks estrogen, progesterone, and HER2 receptors and has spread beyond the breast to other parts of the body. It usually starts as a tumor in the breast tissue and later can travel through the bloodstream or lymph system to distant organs such as bone, liver, lung, or brain. Because the cancer cells do not have the common receptors, they grow and divide without those signals. The disease often shows rapid growth and can form new tumors in multiple locations. Symptoms may include pain, fatigue, or swelling depending on where the cancer has spread.