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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 enrolledin a Genentech and /or F. Hoffmann-La Roche Ltd. – sponsored trastuzumab emtansine study.
EU CTIS ID: 2023-503479-79-00
What this study is testing
- To provide trastuzumab emtansine therapy as single agent or in combination with other agents to HER2-positive metastatic cancer patients who derived benefit from therapy administered in the Genentech/Roche-sponsored trastuzumab emtansine parent study. - To provide continued study treatment to patients in the control arm of study BO21976/TDM4450g who derived benefit from the treatment administered during the study. - To collect safety data with regard to long-term administration of single agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents.
- Therapeutic exploratory (Phase II)
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
- 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 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 at the time of the study closure
- Adequate organ function, evidenced by the following laboratory results within 7 days of the first study drug infusion for this study: Absolute neutrophil count > 1000 cells/mm3 Platelet count > 75,000 cells/mm3 Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 5 x the ULN Creatinine < 1.8 x the ULN
- Expectation by the investigator that the patient may continue to benefit from additional study treatment.
- LVEF ≥ 40% at baseline within 30 days prior to study entry as determined by either ECHO or MUGA Patients with an LVEF ≥ 40%-45% must have had an absolute change of <10% from baseline (using as reference the baseline LVEF from the parent study prior to the start of study therapy).
- ECOG Performance Status of 0-2
- For 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 patient and/or partner during the treatment period 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. For men, agreement to use an effective form of contraception and to continue its use for the duration of the study. Men must refrain from donating sperm during this same period.
You likely can't join if
- Adverse events leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study.
- Ongoing serious adverse events from the parent study
- Progressive disease (except for isolated CNS progression) on single agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study.
- Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version (V) 3.0, V4.0 or V5.0, 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, or history of myocardial infarction within 6 months prior to study entry.
- History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the patient’s last study drug dose in the parent study
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Japan
- Hong Kong
- Chile
- Panama
- Korea, Republic of
- Brazil
- Russian Federation
- Thailand
- Switzerland
- Philippines
- United States
- North Macedonia
- Canada
- Guatemala
- Peru
- China
- United Kingdom
- Israel
- Australia
+ 2 more site(s).
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 Mexico; Japan; Hong Kong; Chile; Panama; Korea, Republic of and 16 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.