A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
This study is an extension for people whose cancer has spread (metastatic neoplasm) and who have been receiving specific cancer treatments, either trastuzumab emtansine (T-DM1) alone or with other anti-cancer drugs, in a previous clinical trial. The main goal is to let these participants continue receiving the treatment they are already benefiting from, even after the earlier study officially ends. This type of study mainly looks at the long-term safety of the treatments when given over a longer period. It's a 'Phase 2' study, which means researchers are still carefully checking the treatment's safety and effectiveness. Participants who meet certain criteria, such as still benefiting from their current treatment, will be able to join and continue their therapy.
At a glance
What is this study about?
This study is designed for people who have been taking part in an earlier research study for cancer that has spread. If you're currently receiving a medication called trastuzumab emtansine (also known as T-DM1) by itself or with other cancer medicines, and your doctors believe it's still helping you, this study might allow you to continue that treatment. It’s essentially a way to keep beneficial treatments going for longer than originally planned in the first study.
The main purpose of this 'extension study' is to gather more information about the long-term safety and effects of these treatments. When new cancer medicines are tested, they often start with shorter studies. If the treatment shows promise and is helping patients, an extension study like this allows researchers to monitor participants for a longer time, which is really important for understanding the full picture of a medicine's effects over time.
By continuing to offer treatment to people who are already doing well on it, this study aims to ensure that those who benefit can keep receiving their therapy. It also helps medical professionals learn more about how these specific cancer treatments work in the long run, contributing to better care for future patients.
Key takeaways
- This study is for people currently doing well on specific cancer treatments in an earlier study.
- It allows you to continue receiving trastuzumab emtansine (T-DM1) or related drugs for longer.
- The main aim is to check the long-term safety of these treatments.
- Your doctors must believe the treatment is still benefiting you to join.
- It's a 'Phase 2' study, focusing on safety and how well the treatment works over time.
Who may be eligible?
This study is for adults, aged 18 or older, who are currently participating in a related cancer study sponsored by Genentech or Roche. To be considered, you must have been receiving trastuzumab emtansine (either alone or with other cancer medicines) or, in some cases, another treatment called the 'control arm' in one of those previous studies.
Crucially, your doctors must believe that you are still benefiting from the treatment you're currently receiving. If your previous study is ending, you must have received your last dose of the study medicine within the last six weeks (42 days) to be able to join this extension study and continue your treatment.
There are also important considerations regarding contraception: if you are a woman who could become pregnant, or a man with a female partner who could become pregnant, you must agree to use highly effective non-hormonal birth control during the study and for a period after your last dose of study medication. This includes not donating eggs for women during this time.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you currently participating in an eligible cancer study sponsored by Genentech or Roche?
- Are your doctors positive that your current study treatment is still helping your cancer?
- Have you used your current study medication recently (within 6 weeks)?
- Are you able and willing to use effective birth control if applicable?
What does participation involve?
If you join this study, you will continue to receive the same treatment you were getting in the previous study, which is either trastuzumab emtansine (T-DM1) alone or in combination with other anti-cancer medicines like atezolizumab, pertuzumab, trastuzumab, docetaxel, or paclitaxel. The type and schedule of your treatment will depend on what you were receiving before.
Your involvement will include regular visits to the clinic for medical check-ups, blood tests, and to receive your study medication. These visits help your doctors monitor your health and how you're responding to the treatment. The total duration of your participation will depend on how you respond to the treatment and your doctor's assessment, allowing you to continue as long as it's beneficial and safe.
Potential risks and benefits
Locations (178)
- City of Hope National Medical CenterVerified postcodeDuarte, United States
- Can Care Assoc Med Group IncVerified postcodeRedondo Beach, United States
- Univ of Calif, San FranciscoVerified postcodeSan Francisco, United States
- Central Coast Medical OncologyVerified postcodeSan Luis Obispo, United States
- UCLA Oncology OfficeVerified postcodeSanta Monica, United States
- Stanford Cancer InstituteVerified postcodeStanford, United States
- Kaiser Permanente - Walnut CreekVerified postcodeWalnut Creek, United States
- Univ of Colorado Canc CtrVerified postcodeAurora, United States
- University of ColoradoVerified postcodeAurora, United States
- Rocky Mountain Cancer Center - DenverVerified postcodeDenver, United States
- Christina Care Institutional Review BoardVerified postcodeNewark, United States
- Florida Cancer SpecialistsVerified postcodeFort Myers, United States
Common questions
What is trastuzumab emtansine (T-DM1)?
It's a specific cancer medicine that combines a targeted drug (trastuzumab) with a chemotherapy drug (emtansine) to deliver treatment directly to cancer cells.
Why is this study called an 'extension study'?
It's an extension because it allows people who were already in an earlier cancer study to continue receiving their beneficial treatment for a longer time, even after the first study finishes.
Who can join this study?
Adults who were already part of a specific Genentech/Roche cancer study, are still benefiting from the treatment, and meet other health requirements.
What is the main goal of this study?
The main goal is to continue providing treatment to patients who are benefiting and to gather more information about the long-term safety of the medicines.
Will I have to pay to be in the study?
Usually, all study-related treatments and tests are provided at no cost, but you should always confirm this with the study site staff.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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