Study on Trastuzumab Deruxtecan, Trastuzumab, and Pertuzumab for Patients with HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer

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What is this study about?

This clinical examination is about patients with a type of breast cancer called HER2-positive unresectable locally recurrent or metastatic breast cancer. This means the cancer has returned or spread and cannot be removed with surgery. The study is trying to see how effective a combination of treatments is for this kind of cancer.

The cancer treatment in this study involves two steps. First, patients receive a drug called trastuzumab deruxtecan, which is given as an intravenous infusion. This is used as an initial or induction treatment. After this, the study uses a combination of drugs called Phesgo, which includes two active ingredients: trastuzumab and pertuzumab. Phesgo is given as an injection and is used to maintain the treatment’s effects after trastuzumab deruxtecan.

The main purpose of this study is to check how long patients can live without the cancer getting worse after one year and the overall survival at three years. Participants in this study have not received chemotherapy or treatments targeting HER2 for their advanced cancer before. The study aims to provide insights into whether the treatment can help control cancer growth and improve patients’ survival.

1 Induction Treatment

The initial phase involves the administration of trastuzumab deruxtecan. This medication is given as an intravenous infusion. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.

This phase aims to reduce the size of the tumor and manage the disease effectively. The duration of this treatment will be specified by the healthcare provider.

2 Maintenance Therapy

Following the induction treatment, the patient will transition to maintenance therapy with Phesgo, which contains trastuzumab and pertuzumab.

Phesgo is administered as a solution for injection. The dosage options include 600 mg/600 mg or 1200 mg/600 mg, depending on the patient’s specific treatment plan.

The frequency and duration of this maintenance therapy will be determined by the healthcare provider, aiming to maintain disease control and prevent progression.

3 Monitoring and Follow-up

Throughout the trial, regular monitoring will be conducted to assess the patient’s response to treatment and manage any side effects.

This includes routine medical evaluations, imaging tests, and laboratory assessments to ensure the treatment’s effectiveness and the patient’s safety.

The healthcare provider will provide specific instructions regarding the schedule and type of follow-up required.

Who Can Join the Study?

The patient must understand the purpose of the study and sign a written informed consent form before starting any study procedures.
The patient should not have received any prior chemotherapy or HER2-targeted therapy for advanced disease. However, one prior line of hormone therapy is allowed for metastatic breast cancer (MBC).
The patient may have received chemotherapy or HER2-targeted therapy before, as long as there was a gap of at least 12 months between the end of that treatment and the diagnosis of metastatic disease.
The patient must have adequate bone marrow and organ function, which includes:
- White blood cell count greater than 3.0 x 10⁹/L.
- Absolute neutrophil count (a type of white blood cell) of at least 1.5 x 10⁹/L.
- Platelet count of at least 100.0 x 10⁹/L.
- Hemoglobin level of at least 9.0 g/dL.
- Serum albumin level of at least 2.5 g/dL.
- Total bilirubin level no more than 1.5 times the upper limit of normal (or 3 times for those with Gilbert’s disease).
- Alkaline phosphatase level no more than 2.5 times the upper limit of normal (or 5 times for those with liver or bone metastases).
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels no more than 1.5 times the upper limit of normal (or 3 times for those with liver metastases).
- Creatinine clearance (a measure of kidney function) of at least 50 mL/min.
- Coagulation tests (blood clotting) within normal limits.
Any side effects from previous cancer treatments must have resolved to a mild level, except for hair loss or other effects not considered a safety risk.
Women who can become pregnant and are sexually active with a male partner must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 7 months after the last treatment.
Men who are sexually active with a female partner who can become pregnant must be surgically sterile or use effective birth control during the study and for 4 months after the last dose of T-DXd or 7 months after the last dose of PHESGO.
The patient must be available for treatment and follow-up visits.
The patient must be 18 years or older at the time of signing the consent form.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
The patient must have a life expectancy of at least 12 weeks at the time of screening.
The patient must have a tumor that overexpresses HER2, confirmed by a designated central lab.
The patient must have known estrogen receptor (ER) and progesterone receptor (PgR) status before entering the study.
The patient must have unresectable locally recurrent or metastatic disease confirmed by a CT scan or MRI that cannot be removed with surgery for a cure.
The patient must have disease that can be measured according to specific criteria (RECIST v.1.1).
The patient must provide a recent tumor tissue sample. If no previous sample is available, a new biopsy of an accessible tumor is required before starting the study treatment.

Who Cannot Join the Study?

Patients who have already received chemotherapy or treatment specifically targeting HER2 for advanced breast cancer cannot participate. HER2 is a protein that can affect the growth of cancer cells.
Patients with breast cancer that can be surgically removed are not eligible. Unresectable means the cancer cannot be removed with surgery.
Patients with breast cancer that has not spread beyond the local area or has not come back after treatment are not eligible. Locally recurrent means the cancer has returned in the same area after treatment.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Hospital Beata Maria Ana	Madrid	Spain
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
MD Anderson Cancer Center	Madrid	Spain
Marienhospital Bottrop gGmbH	Bottrop	Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH	Moenchengladbach	Germany
Mammazentrum Hamburg MVZ GbR	Hamburg	Germany
Hospital Universitario Del Vinalopo	Elche	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital General Universitario De Alicante	Alicante	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Arnau De Vilanova De Valencia	Valencia	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Universitario Clínico San Cecilio	Granada	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Leon	Leon	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Iyndxmpm Cdltki Deqzfaggiwrbcotko	L'hospitalet De Llobregat	Spain
Huygpjdp Uchhcwgmmsjyr Demkqkmr	Donostia / San Sebastian	Spain
Kipclkyf dzx Urwjqybuujnm Mpzykltw Ald	Munich	Germany
Fphxbenac Petb Lz Idvkvlseklwfw Bwmewqxvs Dqn Hpexnhhk Urtwqvdihtwln Lm Psa	Madrid	Spain
Kwkuyacj Eupgfiwzrokqbonhxwwvmyru Hhkolbowdcgkeyxlo	Essen	Germany
Isjcfrml Peyrogzmyqfgsju Comlst Cjocpx	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2024
Germany	Not recruiting	01.04.2024
Italy	Not recruiting	01.04.2024
Spain	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan (T-DXd) is a medication used as an initial treatment in this trial. It is designed to target and attack HER2-positive cancer cells, which are a type of breast cancer cell that has higher levels of a protein called HER2. This medication helps to slow down or stop the growth of these cancer cells.

PHESGO is a combination of two medications, Trastuzumab and Pertuzumab, used as a maintenance therapy in this trial. After the initial treatment with Trastuzumab Deruxtecan, PHESGO is given to help keep the cancer from coming back or growing. It works by continuing to target the HER2 protein on cancer cells, helping to control the disease over a longer period.

Investigated diseases:

HER2 positive breast cancer

HER2-positive unresectable locally recurrent or metastatic breast cancer – This type of breast cancer is characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It is termed “unresectable” when the cancer cannot be surgically removed, and “locally recurrent” when it returns in the same area after treatment. “Metastatic” indicates that the cancer has spread to other parts of the body. The disease progresses as cancer cells continue to grow and spread, often affecting other organs. Patients with this condition may experience symptoms related to the growth and spread of tumors, such as pain or swelling in affected areas. The progression of the disease can vary widely among individuals, depending on various factors including the biology of the cancer and the patient’s overall health.

Trial ID:

2023-507306-13-00

Protocol code:

MEDOPP562

NCT ID:

NCT06172127

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Trastuzumab Deruxtecan, Trastuzumab, and Pertuzumab for Patients with HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?