TRASTUZUMAB EMTANSINE for HER2-positive breast cancer|Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- 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\n- 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\n- Expectation by the investigator that the patient may continue to benefit from additional study treatment.\n- 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).\n- ECOG Performance Status of 0-2\n- 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."}

Exclusion criteria

• {"criterion_text":"- Adverse events leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study.\n- Ongoing serious adverse events from the parent study\n- 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.\n- 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.\n- 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.\n- 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"}

Primary endpoints

• {"endpoint_text":"- 1. Incidence of adverse events leading to trastuzumab emtansine or combination treatment discontinuation or dose reduction.\n- 2. Incidence of all adverse events and all serious adverse events","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- N/A","definition_or_measurement_approach":""}

Portugal

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

672

Number Of Sites

2

Number Of Participants

6

Belgium

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

667

Number Of Sites

1

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

673

Number Of Sites

1

Number Of Participants

22

Poland

Earliest CTIS Part Ii Submission Date

06-02-2024

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

671

Number Of Sites

3

Number Of Participants

14

France

Earliest CTIS Part Ii Submission Date

14-03-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

635

Number Of Sites

2

Number Of Participants

13

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Signant Health Global LLC

Responsibilities

sponsorDuties code: 3; contact: EU_ClinicalRegulation@signanthealth.com; phone: 12674221700

Name

IQVIA Limited

Responsibilities

sponsorDuties code: 1; contact: eu_clinical_trials_information@iqvia.com; phone: 441184508000

Third parties

• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code: 3; contact email: EU_ClinicalRegulation@signanthealth.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code: 1; contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}