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An open-label extension study of pertuzumab administered on its own or in combination with other anti-cancer therapies in patients previously enrolled in a Hoffmann-La Roche sponsored pertuzumab study
EU CTIS ID: 2023-505102-42-00
What this study is testing
To provide continued pertuzumab therapy to patients who were previously enrolled in a F. Hoffmann-La Roche (Roche)-sponsored pertuzumab study (the Parent study) and who continue to derive benefit from pertuzumab-based therapy administered in the Parent study at the time of Parent study closure.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written Informed consent approved by the relevant Ethics Committee (EC) or the Institutional Review Board (IRB)
- Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
- Investigator's opinion that the patient continues to benefit from pertuzumab treatment
You likely can't join if
- Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
- Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
- Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion 5 below.
- More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
- Left ventricular ejection fraction ≤ 50%
- Positive serum pregnancy test in women of childbearing potential (WOCBP) defined as pre-menopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Ukraine
- China
- Korea, Republic of
- Peru
- Japan
- Mexico
- Russian Federation
- Costa Rica
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Ukraine; China; Korea, Republic of; Peru; Japan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.