Eine Verlängerungsstudie zur Sicherheit und Wirksamkeit von Pertuzumab bei Patient*innen mit soliden Tumoren, die zuvor an einer von Hoffmann-La Roche gesponserten Pertuzumab-Studie teilgenommen hatten

1. Why is this study needed?

The PerEx study is an extension study and takes place after the parent study is over, allowing participants that keep on benefiting from the study treatment to continue their treatment. This study gives people with HER2 positive cancer that continued to benefit from the study drug pertuzumab the chance to keep receiving pertuzumab-based treatment after the parent study ended. HER2, also known as human epidermal growth factor receptor 2, is a protein involved in normal cell growth. It can be made in larger than normal amounts by some types of cancer cells, including breast cancer cells, and cause cancer cells to grow more quickly. ‘HER2-positive’ means that cancer cells have more HER2 than normal. Checking the amount of HER2 on some types of cancer cells may help to plan treatment. Medicines that target HER2 can help treat this type of cancer.

This study is testing a medicine called pertuzumab, either on its own or together with other cancer treatments. It is being developed to treat cancer cells that grow in organ systems throughout the body (solid tumour).

Pertuzumab is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved pertuzumab (in combination with other cancer treatment) for the treatment of certain solid tumours.

This study aims to find out how well pertuzumab works and how safe it is over a long period of time, either alone or with other cancer treatments, in people with HER2 positive solid tumour who continue to receive benefit from pertuzumab-based treatment in the parent study when it ended.

2. Who can take part in the study?

People (males and females) with HER2 positive solid tumours can take part in the study if they were previously a part of Hoffman-La Roche-sponsored study (Parent study) where they received pertuzumab, and the study doctor recommends continuing pertuzumab treatment after the parent study ended.

People may not be able to take part in this study if they have signs that the disease is getting worse, stopped taking pertuzumab permanently for any reason during the original study, more than 9 weeks have passed since the last dose of pertuzumab in the original study, or have been given certain medicines within a certain timeframe before the study.

People who are pregnant, or currently breastfeeding cannot take part in the study.

3. How does this study work?

People will be screened to check if they are able to participate in the study. The screening period will take place from 28 days before the start of treatment.

Everyone who joins this study will be given pertuzumab either alone or in combination with other cancer treatments as a drip into a vein (infusion) every 3 weeks.

This is an open-label study. This means everyone involved, including the participant and the study doctor, will know the study treatment the participant has been given.

During this study, the study doctor will see participants every 3 weeks. They will see how well the treatment is working and any unwanted effects participants may have. Participants will have follow-up visits 4 and 7 months after their last dose of study treatment, during which the study doctor will check on the participant’s well being . Total time of participation in the study will be until the participant completes their 7 month check up after receiving the last dose of the treatment. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so.

4. What are the main results measured in this study?

The main results measured in the study to assess if the medicine has worked are how long participants live and how long they live without their cancer getting worse. Other key results measured in the study include the unwanted effects of treatment.

5. Are there any risks or benefits in taking part in this study?

This study is open to participants who have been doing well with pertuzumab-based treatment in the parent study. Taking part in the study may or may not make participants feel better. But the information collected in the study can help other people with similar health conditions in the future.

It may not be fully known at the time of the study how safe and how well the study treatment works. The study involves some risks to the participant. But these risks are generally not greater than those related to routine medical care or the natural progression of the health condition. People interested in taking part will be informed about the risks and benefits, as well as any additional procedures or tests they may need to undergo. All details of the study will be described in an informed consent document. This includes information about possible effects and other options of treatment.

Risks associated with the study drugs
Participants may have unwanted effects of the drugs used in this study. These unwanted effects can be mild to severe, even life-threatening, and vary from person to person. During this study, participants will have regular check-ups to see if there are any unwanted effects.

Pertuzumab
Participants will be told about the known unwanted effects of pertuzumab both alone and in combination with other cancer treatments, and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include allergic reactions, loose, watery [and more frequent] stools, the inside linings of the body, like the mouth and nose, get irritated, and heart failure.

Known unwanted effects of a drip into a vein include fever, a feeling of coldness that makes the body shiver, low blood pressure, discomfort in breathing, a rash on the skin where it has been pricked with a needle to give a treatment, pain or discomfort in the head, wanting to throw up, throwing up.

The study medicine(s) may be harmful to an unborn baby. Women and men must take precautions to avoid exposing an unborn baby to the study treatment.