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Radium-223 dichloride (223RaCl) with drug combination for patients with symptomatic bone metastases from breast cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The study focuses on patients with symptomatic bone metastases from breast cancer. Bone metastases are sites where cancer that started in the breast has spread to the bones, causing pain and other problems. The investigational treatment is a radiopharmaceutical called Radium223 dichloride (223RaCl) given by intravenous injection. The trial also includes groups that receive the radiopharmaceutical together with standard hormone‑blocking pills such as exemestane, letrozole, or anastrozole, which are taken by mouth.

The purpose of the study is to evaluate the efficacy and safety of the radiopharmaceutical alone or in combination with these hormone blockers. Participants receive a series of injections over several months, and those in the combination arms take one of the oral pills daily. Throughout the study, doctors monitor pain levels, overall well‑being, and any side effects, and they check blood tests for an enzyme called alkaline phosphatase that can show how the bones are responding.

The trial follows each person from the first dose until the disease progresses, they stop treatment, or the study ends. Researchers record how long patients live without the disease getting worse (progression‑free survival) and overall survival, as well as quality of life, to understand the potential benefit of the new therapy.

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
Signing informed consent and enrollment
After agreeing to participate, the consent form is signed and the patient is officially enrolled in the study.
Step 2
Baseline evaluation
A complete medical history is recorded, including assessment of bone pain and quality of life using standard questionnaires.
Blood samples are taken to measure baseline alkaline phosphatase and other routine laboratory values.
Step 3
First treatment administration
The first dose of radium223 dichloride is given by intravenous injection. the dose is 55 kbq/kg (kilobecquerel per kilogram).
If the patient is assigned to a combination arm, an oral aromatase inhibitor is started at the same time:
- exemestane: 25 mg taken once daily by mouth.
- letrozole: 2.5 mg taken once daily by mouth.
- anastrozole: 1 mg taken once daily by mouth.
Step 4
Subsequent radium223 injections
Additional doses of radium223 dichloride are administered according to the study schedule, each dose using the same amount (55 kbq/kg) and route (intravenous).
Step 5
Regular follow‑up visits
At each scheduled visit, pain levels, quality of life, and any side effects are recorded.
Blood tests, including alkaline phosphatase, are repeated to monitor changes.
The oral aromatase inhibitor, if prescribed, continues to be taken daily at the same dose.
Step 6
Completion of treatment phase
After the final planned dose of radium223 dichloride, the treatment phase ends.
Final assessments of pain, quality of life, and laboratory values are performed.
Step 7
Post‑treatment follow‑up
The patient continues to be monitored for overall survival, disease progression, and any long‑term effects until the study end date.

Who can join the trial?

8 criteria

Be at least 18 years old.
Have a confirmed diagnosis of breast cancer based on examination of tissue under a microscope (histological confirmation).
Have cancer that has mainly spread to the bones, with at least two bone lesions seen on a baseline bone scan (a special X‑ray test that shows bone disease).
It is allowed to have a few cancer spots in soft parts of the body such as skin, muscle, fat, or lymph nodes (soft tissues).
Have a Performance Status score of 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well you can carry out daily activities.
Have an absolute neutrophil count of at least 1.5 × 10⁹ per liter (a measure of a type of white blood cell that helps fight infection).
Have a platelet count of at least 100 × 10⁹ per liter and not have received a platelet transfusion in the four weeks before the first treatment dose (platelets help blood clot).
Have a hemoglobin level of at least 9.0 g/dL (100 g/L) and not have received a blood transfusion or the drug erythropoietin in the four weeks before the first treatment (hemoglobin carries oxygen in the blood).

Who cannot join the trial?

4 criteria

Having cancer that has spread to internal organs (known as visceral disease) or having other health problems that require strong cancer‑killing drugs called cytotoxic chemotherapy.
Having carcinomatous lymphangitis, which means cancer cells are spreading through the lymph vessels.
Having had any other type of cancer in the past, except for a previously treated skin cancer called basal cell carcinoma or an early‑stage bladder cancer called superficial bladder cancer (stages Ta or Tis).
Having received previous whole‑body radiation treatment that used the radioactive substances strontium‑89, samarium‑153, rhenium‑186, or rhenium‑188.

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy

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Investigated drugs

Radium‑223 dichloride
is a radioactive medication given through an IV. It travels to the bones and delivers tiny amounts of radiation directly to cancer cells that have spread to the bone. This helps to slow the growth of bone metastases and can reduce bone pain in patients with breast cancer.
Exemestane
is a pill taken by mouth that blocks an enzyme called aromatase. By blocking this enzyme, the drug lowers the amount of estrogen in the body. Since many breast cancers need estrogen to grow, reducing estrogen can help slow the cancer. In the trial, it is used alone or together with radium‑223 to see if the combination works better.
Letrozole
is another oral medication that works in the same way as exemestane. It stops the body from making estrogen, which can help control breast cancer that depends on estrogen. The study looks at how letrozole works by itself and when combined with radium‑223.
Anastrozole
is also an oral aromatase‑inhibiting drug. It lowers estrogen levels to help treat hormone‑sensitive breast cancer. In this trial, anastrozole is tested as a single treatment and as part of a combination with radium‑223 to see if patients get extra benefit.

What is already known about the treatment

EXEMESTANE
This medication is taken as a 25 mg oral tablet once daily. It is an approved drug used mainly for postmenopausal women with hormone‑sensitive breast cancer that has spread to bone. Exemestane works by permanently blocking the aromatase enzyme, which stops the body from making estrogen that can feed cancer cells. It belongs to the class of steroidal aromatase inhibitors and is well documented in medical literature.
RADIUM (223RA) DICHLORIDE
This drug is given by an intravenous injection, with a dose measured in kilobecquerels per kilogram of body weight. It is a radiopharmaceutical that is still being studied for treating painful bone metastases from breast cancer, although it is already approved for bone metastases in prostate cancer. The compound releases alpha‑particle radiation that travels only a short distance, targeting and destroying cancer cells in bone while sparing most surrounding tissue. It is classified as an alpha‑emitting radiopharmaceutical and is considered experimental for breast cancer.
LETROZOLE
Letrozole is taken as a 2.5 mg oral tablet each day. It is an approved treatment for postmenopausal women with estrogen‑dependent breast cancer that has spread to bone. The drug blocks the aromatase enzyme, lowering estrogen levels and slowing tumor growth. It is a non‑steroidal aromatase inhibitor and is widely referenced in clinical studies.
ANASTROZOLE
Anastozole is administered as a 1 mg oral tablet once daily. It is also an approved therapy for hormone‑sensitive breast cancer in postmenopausal patients with bone involvement. Like other aromatase inhibitors, it stops the enzyme that makes estrogen, thereby reducing the hormone that fuels cancer cells. It belongs to the non‑steroidal aromatase inhibitor class and is well established in medical practice.

Investigated diseases

Symptomatic bone metastases from breast cancer - Bone metastases from breast cancer are cancer cells that have spread from the original breast tumor to the bones. They often cause pain, fractures, and other bone problems. The spread usually occurs when cancer cells travel through the bloodstream or lymph system to bone tissue. Over time, the lesions can enlarge, weakening the bone and involving additional sites. Symptoms may increase as more bone areas become affected.