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An Extension Study of trastuzumab emtansine administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolled in a Genentech and /or F. Hoffmann-La Roche Ltd. – sponsored trastuzumab emtansine study
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
- Cancer
- Tumor
- Neoplasms
- Neoplasm Metastasis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Countries
- Belgium
- Brazil
- China
- France
- Italy
- Panama
- Peru
- Poland
- Portugal
- South Korea
- Spain
Trial Identifier:
NCT00781612 TDM4529g, 2023-503479-79-00 BO25430
Trial Summary
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT00781612,BO25430,TDM4529g, 2023-503479-79-00,2010-021067-32 , 2023-503479-79-00
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
1. Why is this study needed?
Breast cancer is a health condition where cancer cells form in the breast. Breast cancer can sometimes be diagnosed as ‘metastatic’. Metastatic cancer is cancer that has spread to other parts of the body. Some cancers have more human epidermal growth factor receptor 2 (HER2) than normal. HER2 is a protein involved in normal cell growth. When cancers are ´HER2-positive’, the extra HER2 causes cancer cells to grow more quickly. Better treatments are needed for HER2-positive breast cancers that have spread to other parts of the body.
This study is testing a medicine called trastuzumab emtansine on its own and combined with other anti-cancer medicines (atezolizumab, pertuzumab, docetaxel and paclitaxel).
Trastuzumab emtansine on its own is approved in some countries by health authorities like the U.S. Food and Drug Administration and European Medicines Agency. This is for HER2-positive breast cancer that has been treated with trastuzumab and another type of anti-cancer medicine called a taxane. Atezolizumab is approved in some countries for treating a type of breast cancer called ‘triple negative breast cancer’ that has spread. It is not approved for treating HER2-positive breast cancer. Pertuzumab in combination with trastuzumab is approved in some countries for treating HER2-positive breast cancer that has spread. Pertuzumab combined with trastuzumab and either docetaxel or paclitaxel are also approved in some countries to treat HER2-positive breast cancer. This includes cases with or without spread.
Trastuzumab emtansine combined with other anti-cancer medicines are experimental treatments. This means health authorities have not approved these combinations for the treatment of HER2-positive breast cancer. This study aims to continue to assess the safety of trastuzumab emtansine. It will be studied on its own and combined with other anti-cancer medicines. The study will include people with HER2-positive breast cancer that has spread. Participants must have benefited from trastuzumab emtansine or trastuzumab treatment in a Genentech and/or F. Hoffmann-La Roche Ltd–sponsored study (called a parent study).
2. Who can take part in the study?
People of 18 years of age or older with HER2-positive breast cancer that has spread can take part in the study. But only if they have completed treatment in a parent study within the last 6 weeks. They must be expected to benefit from being given trastuzumab emtansine or from continuing their study treatment. They must also not be able to access their study treatment elsewhere.
People may not be able to take part in this study if their cancer got worse during the parent study. People who had unwanted effects from study medicines that were serious or caused them to stop treatment also cannot take part. People who are pregnant, or currently breastfeeding cannot take part in the study.
3. How does this study work?
Participants will be screened to check if they are able to participate in the study. The screening period will take place from 1 day to 1 month before the start of treatment.
Everyone who joins this study will continue to receive the same study treatment they were given during the parent study. Treatment will be once a week or once every 3 weeks instead if participants agree. If a participants’ cancer got worse when being given trastuzumab and docetaxel in the parent study, they may be given trastuzumab emtansine instead. If participants no longer benefit from trastuzumab and docetaxel during this study, they may get trastuzumab emtansine. This includes those who have unacceptable unwanted effects. Study treatment will be given as often as it was given during the parent study.
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 regularly to see how well the treatment is working and any unwanted effects participants may have. Participants will have a follow-up visit within 1 month of stopping study treatment, during which the study doctor will check on the participant’s wellbeing. Participants who can get pregnant will also have 2 follow-up visits 3 and 7 months after stopping study treatment. Total time of participation in the study could be more than 1 month. Participants have the right to stop study treatment and leave the study at any time, if they wish to do so. Participants will not lose access to regular care if they stop study treatment.
4. What are the main results measured in this study?
The main results measured in the study to assess if the medicines have worked are:
- The number of participants who have unwanted effects and serious unwanted effects
- The number of participants who stop study treatment or have a lower dose of study treatment due to unwanted effects
5. Are there any risks or benefits in taking part in this 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 medicines
Participants may have unwanted effects of the medicines 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.
Trastuzumab emtansine, atezolizumab, pertuzumab, trastuzumab, docetaxel and paclitaxel
Participants will be told about the known unwanted effects of trastuzumab emtansine, atezolizumab, pertuzumab, trastuzumab, docetaxel and paclitaxel, and possible unwanted effects based on human and laboratory studies or knowledge of similar medicines. Known unwanted effects include difficulty breathing while resting, feeling tired or weak, having a lack of energy, rash, fever, a feeling of coldness that makes the body shiver, cough, difficulty sleeping, throwing up and wanting to throw up.
Trastuzumab emtansine, atezolizumab, pertuzumab, trastuzumab, docetaxel and paclitaxel will be given as a drip into a vein (infusion). Known unwanted effects of drips into a vein include itching, rash, throat pain, reddening of the skin, headache, fever, a feeling of coldness that makes the body shiver, feeling tired or weak, throwing up and wanting to throw 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.
Trial Summary
This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.
Genentech, Inc.
Sponsor
Phase 2
Phase
NCT00781612,BO25430,TDM4529g, 2023-503479-79-00,2010-021067-32 , 2023-503479-79-00
Trial Identifier
Docetaxel, Paclitaxel, Pertuzumab, Trastuzumab, Trastuzumab Emtansine, Atezolizumab
Treatments
Neoplasm Metastasis
Condition
Official Title
An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension study
- Participants in the control arm from Study BO21976/TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDM4529g (NCT00781612)
- Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
- Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the participants and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab, trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period
- Male participants whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period
Exclusion Criteria
- AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
- Ongoing SAEs from the parent study
- Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDM4688g (NCT00943670) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
- Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, 4.0 or 5.0, as utilized in the parent study
- History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry
- Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease (for example [e.g.] clinically significant cardiovascular, pulmonary, or metabolic disease)
- Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
- Current pregnancy or lactation
- History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study
- History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
For the latest version of this information please go to www.forpatients.roche.com