Study on Trastuzumab Emtansine, Pertuzumab, and Atezolizumab for Patients with HER2-Positive Metastatic Cancer Who Benefited from Previous Treatment

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What is this study about?

This clinical trial is focused on studying treatments for metastatic cancer, which is a type of cancer that has spread from its original site to other parts of the body. The study involves the use of several medications, including trastuzumab emtansine, pertuzumab, and atezolizumab. Trastuzumab emtansine is being tested both as a single treatment and in combination with other anti-cancer therapies. Pertuzumab and atezolizumab are also being used in combination with trastuzumab emtansine to explore their effectiveness in treating this condition.

The purpose of the study is to provide continued treatment to patients who have previously benefited from these therapies in earlier studies. The trial aims to gather information on the safety of long-term use of trastuzumab emtansine, whether used alone or with other medications. Patients who have shown positive results from previous treatments with these drugs are given the opportunity to continue their therapy in this extension study.

Participants in the study will receive their treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor patients over a period to assess the safety and any side effects of the treatments. This trial is designed to ensure that patients who have responded well to these medications can continue to receive them and to collect valuable data on their long-term use.

1 joining the study

Upon joining the study, the patient must have completed previous treatment with trastuzumab emtansine or be continuing treatment at the time of the parent study’s closure.

The patient must have received the last dose of the study drug within 6 weeks prior to the first dose in this extension study.

2 initial assessment

An initial assessment is conducted to ensure adequate organ function. This includes checking blood counts, liver function, and kidney function.

The patient’s heart function is evaluated, requiring a left ventricular ejection fraction (LVEF) of at least 40%.

3 treatment administration

The patient receives trastuzumab emtansine as a single agent or in combination with other medications such as pertuzumab and atezolizumab.

All medications are administered through an intravenous infusion, which involves delivering the drug directly into the bloodstream through a vein.

4 treatment schedule

The specific dosage and frequency of each medication are determined by the study protocol and the patient’s response to treatment.

The treatment continues as long as the patient is benefiting from it, as assessed by the study investigators.

5 monitoring and follow-up

Regular monitoring is conducted to track the patient’s response to treatment and any side effects.

Safety data is collected to understand the long-term effects of the treatment.

6 end of study participation

The study is estimated to conclude by September 26, 2029.

The patient may continue to receive treatment until the study ends or until it is determined that they are no longer benefiting from the treatment.

Who Can Join the Study?

The patient must have completed or be continuing treatment with trastuzumab emtansine (a type of cancer medication) in a previous study, or be in the control group of a specific study at the time it ended.
The patient must have adequate organ function, shown by specific lab results within 7 days before starting the study drug. This includes:
- Absolute neutrophil count (a type of white blood cell) greater than 1000 cells/mm³
- Platelet count (cells that help blood clot) greater than 75,000 cells/mm³
- Total bilirubin (a substance made by the liver) less than or equal to 1.5 times the upper limit of normal
- SGOT (AST) and SGPT (ALT) (liver enzymes) less than or equal to 5 times the upper limit of normal
- Creatinine (a waste product in the blood) less than 1.8 times the upper limit of normal
The doctor must expect that the patient may continue to benefit from more study treatment.
The patient must have a Left Ventricular Ejection Fraction (LVEF) of 40% or higher, measured within 30 days before joining the study. LVEF is a measure of how well the heart pumps blood.
The patient must have an ECOG Performance Status of 0-2, which is a scale used to assess how a patient’s disease is affecting their daily living abilities.
Women who can have children and men with partners who can have children must agree to use a highly effective form of non-hormonal birth control or two effective forms of non-hormonal birth control during the treatment and for a certain period after the last dose of the study drugs. Women must not donate eggs, and men must not donate sperm during this time.

Who Cannot Join the Study?

Patients who do not have HER2-positive metastatic cancer. This means the cancer must have a specific protein called HER2 that helps it grow.
Patients who did not benefit from previous treatment with trastuzumab emtansine. This is a specific medication used to treat HER2-positive cancer.
Patients who were not part of the Genentech/Roche-sponsored trastuzumab emtansine parent study. This refers to a previous study where the medication was given.
Patients who were not in the control group of the BO21976/TDM4450g study and did not benefit from the treatment given in that study.
Patients who are not within the specified age range for the study. The study includes certain age groups only.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Sqmakucfwsw Pxdokxdgm Zpkjhq Oxatay Zjojkvasuu Woejmedjrp Sdpejfw Szxwxqnifjagdej Na 3 W Rragaot	Rybnik	Poland
Nwlgznme Inzwpecy Ogxllhaky Iel Mplop Syelnxkjtwsbjyntbuqavonpoloj Ipihgrfx Brlzojdj	Cracow	Poland
Ibnjeqxt Cowpq	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	13.07.2011
France	Recruiting	13.07.2011
Poland	Recruiting	13.07.2011
Portugal	Recruiting	13.07.2011
Spain	Recruiting	13.07.2011

Trial locations

Investigated drugs:

Trastuzumab Emtansine is a medication used in this trial as a single agent or in combination with other anti-cancer therapies. It is designed for patients with HER2-positive metastatic cancer who have previously benefited from this treatment in earlier studies. The medication works by targeting and attacking cancer cells that have high levels of the HER2 protein, helping to slow or stop the growth of the cancer.

Investigated diseases:

HER2 positive breast cancer

Metastatic Cancer – Metastatic cancer occurs when cancer cells spread from the primary site to other parts of the body. This process involves cancer cells breaking away from the original tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs or tissues. The progression of metastatic cancer can vary depending on the type of primary cancer and the organs affected. Common sites for metastasis include bones, liver, lungs, and brain. Symptoms may differ based on the location of the metastases and can include pain, fatigue, and organ-specific issues. The disease is often more challenging to manage due to its widespread nature.

Trial ID:

2023-503479-79-00

Protocol code:

BO25430

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Trastuzumab Emtansine, Pertuzumab, and Atezolizumab for Patients with HER2-Positive Metastatic Cancer Who Benefited from Previous Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?