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Premedication with dexamethasone to prevent interstitial lung disease in breast cancer patients receiving trastuzumab deruxtecan

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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 Breast Cancer who are being treated with a medication called trastuzumab deruxtecan. This cancer drug can sometimes cause a lung problem known as interstitial lung disease, which is inflammation and scarring of the tiny air sacs in the lungs that can make breathing difficult. To try to prevent this, participants will receive a short course of a steroid tablet named dexamethasone before each cancer treatment dose.

The purpose of the study is to find out whether taking dexamethasone beforehand lowers the chance of developing interstitial lung disease in these patients. Participants will continue their usual cancer therapy, and the study will add the dexamethasone tablets for a set period. Over the next year, they will have regular doctor visits, blood tests, and lung checks to see how they are doing.

Doctors will use a special imaging test called a high-resolution thorax CT scan to get detailed pictures of the lungs and will watch for any side effects such as nausea, liver changes, cough, or shortness of breath. The study will also record overall well‑being and quality of life throughout the follow‑up period.

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
Enrollment and randomization
After joining the study you will be randomly assigned to receive premedication with dexamethasone before each dose of trastuzumab deruxtecan.
Step 2
Baseline lung assessment
A high‑resolution chest ct scan will be performed to evaluate the condition of your lungs before starting treatment.
Step 3
Start of treatment with premedication
You will begin receiving trastuzumab deruxtecan infusions.
Before each infusion you will take one tablet of dexamethasone containing 8 mg of the active ingredient, taken by mouth (buccal use) as instructed.
The premedication will be continued for every infusion throughout the treatment period, which may last up to twelve months.
Step 4
Scheduled follow‑up ct scans
High‑resolution chest ct scans will be repeated at month 3, month 6, month 9, and month 12 after randomization to check for the development of interstitial lung disease.
Step 5
Monitoring of side effects
At each visit you will be asked about symptoms such as nausea, vomiting, cough, shortness of breath, and any changes in liver test results.
These observations help determine whether any adjustments to the medication are needed.
Step 6
Dose adjustments or treatment discontinuation
If serious side effects occur, the study team may reduce the dose of trastuzumab deruxtecan or stop treatment permanently.
Step 7
Final assessment
At the twelve‑month mark a final high‑resolution chest ct scan and overall evaluation will be performed to assess the presence of interstitial lung disease and the overall outcome of the study.

Who can join the trial?

18 criteria

Provide a signed, written and dated consent form agreeing to take part in the study.
Be at least 18 years old (or meet the legal age of consent in your country) at the time you sign the consent.
Have a diagnosis of metastatic breast cancer (cancer that has spread beyond the breast) that has been confirmed by a pathologist looking at tissue or cells under a microscope, and be eligible to receive the drug T‑DXd at the study site.
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Be ready to start T‑DXd treatment according to one of the following patterns:
- If the cancer is hormone‑receptor‑positive (meaning it grows in response to hormones) and has low or ultra‑low HER2, you must have had no more than two prior chemotherapy regimens for advanced disease.
- If the cancer is hormone‑receptor‑negative and has low HER2, you must also have had no more than two prior chemotherapy regimens for advanced disease.
- If the cancer is HER2‑positive (a protein that can make the cancer grow faster), you may have had up to three prior chemotherapy regimens for advanced disease, regardless of hormone‑receptor status.
- Have an ECOG performance status of 0 or 1, which means you are fully active or able to do light work but are still able to take care of yourself.
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  Show adequate bone‑marrow function, meaning recent blood tests must meet these levels:
  - Absolute neutrophil count (a type of white blood cell) of at least 1.5 × 10⁹/L.
  - Platelet count (helps blood clot) of at least 100 × 10⁹/L.
  - Hemoglobin (carries oxygen) of at least 9.0 g/dL.
  - Show adequate liver function, meaning recent blood tests must be within these limits:
    
    Serum albumin (a protein made by the liver) of at least 2.5 g/dL.
    Total bilirubin (a waste product processed by the liver) not higher than 1.5 times the normal upper limit (up to 3 × normal if you have liver metastases or a condition called Gilbert’s disease).
    Alkaline phosphatase (an enzyme) not higher than 2.5 times the normal upper limit.
    AST and ALT (liver enzymes) not higher than 3 times the normal upper limit (up to 5 × normal if you have liver metastases).
    International Normalized Ratio (INR, a test of blood clotting) less than 1.5.
    Allow enough time for your body to recover before randomization:
    
    At least 4 weeks after any major surgery or chest radiation.
    At least 2 weeks after other types of radiation that are not aimed at the chest.
    Be willing and able to follow all study procedures, attend scheduled visits, receive the treatment, and complete follow‑up examinations for the duration of the trial.

Who cannot join the trial?

17 criteria

Having uncontrolled diabetes mellitus (type 1 or type 2) with a recent blood‑sugar test (HbA1c) higher than 8.5%.
Being unable to take pills, having chronic nausea, having had major stomach or bowel surgery, a condition that prevents nutrient absorption, or any other gut problem that could stop the study drug from being absorbed.
Having received limited‑field radiation therapy less than 2 weeks ago for areas that are not the chest, or less than 4 weeks ago for the chest or for large portions of bone marrow.
Having received a live, weakened (attenuated) vaccine within 30 days before the first study dose, and not being able to receive any live vaccine during the study and up to 390 days after the last dose.
Having an active, uncontrolled infection that requires treatment with intravenous (IV) antibiotics, antivirals, or antifungal medicines.
Showing evidence of ongoing alcohol or drug abuse, as judged by the study doctor.
Having a severe medical illness or serious mental‑health condition that the doctor believes would make participation unsafe.
Being able to become pregnant or father a child and not agreeing to use a highly effective birth‑control method or to avoid sexual intercourse for the duration of the study; women who cannot become pregnant are those who have had a hysterectomy or tubal ligation or who are post‑menopausal (no periods for at least 12 months).
Having a known allergy or strong reaction to the study medicines or any of their inactive ingredients.
Having any condition that makes the use of dexamethasone unsafe, as decided by the doctor and medical monitor.
Already taking chronic steroid medication (for example, 10 mg per day of prednisone or an equivalent drug).
Needing oxygen therapy while at rest.
Having documented lung inflammation (pneumonitis or interstitial lung disease) before the first day of treatment.
Having uncontrolled or serious heart problems, such as a heart attack within the past 6 months, moderate to severe heart failure, high blood‑troponin levels without symptoms, uncontrolled high blood pressure, irregular heart rhythms, or a prolonged QT interval on an ECG (longer than 470 ms for women or 450 ms for men).
Having poor kidney function, measured by a creatinine clearance less than 30 mL per minute (a test that shows how well the kidneys filter waste).
Having active or newly diagnosed cancer spread to the brain or its covering (CNS metastases or meningeal carcinomatosis).
Having a recent respiratory infection within the past 28 days.

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Verified sites

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

Verified
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

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Investigated drugs

Dexamethasone
is a short‑acting steroid medicine that helps reduce inflammation and suppresses the immune system. In this study it is given before each dose of cancer treatment to see if it can lower the chance of developing interstitial lung disease, a type of lung problem that can happen with the cancer drug.
Trastuzumab deruxtecan
is a targeted cancer therapy used for HER2‑positive breast cancer. It combines an antibody that finds cancer cells with a chemotherapy drug that kills them. Patients in the trial receive this medication as their main cancer treatment, and the study looks at whether the steroid pre‑medication can make this therapy safer for the lungs.

Dexamethasone

What is already known about the treatment

Dexamethasone 4 mg tablets - It is an oral tablet taken by mouth that contains 4 mg of dexamethasone. Dexamethasone is an approved corticosteroid that is well‑known and widely described in medical literature. It is mainly used to lower inflammation and immune reactions, such as helping prevent lung inflammation in breast cancer patients receiving certain treatments. The drug works by attaching to glucocorticoid receptors inside cells, which then switches off genes that cause inflammation; it belongs to the glucocorticoid (corticosteroid) class.

Investigated diseases

Breast Cancer - Breast cancer begins when cells in the breast start to grow without control, often in the milk‑duct lining or the milk‑producing lobules. The uncontrolled cells can form a lump that may be felt or seen on imaging. As the disease advances, the abnormal cells can invade nearby breast tissue and spread to surrounding lymph nodes. Further progression may allow the cancer to travel through the bloodstream or lymphatic system to distant organs such as bone, liver, lungs, or brain. The condition can move from a stage limited to the breast to more extensive involvement of surrounding structures and distant sites.