HERCEPTIN for intravenous infusion 60 and 150. General drug use-results survey - Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection -

HERCEPTIN for intravenous infusion 60 and 150. General drug use-results survey - Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection - - HERCEPTIN for intravenous infusion 60 and 150. General drug use-results survey - Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046620

Enrollment

Registered

2022-02-01

Start date

2022-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Target cases for enrollment: Patients with advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection to whom HERCEPTIN is scheduled to be administered during the enrollment period in facilities where a contract for this surveillance has been concluded. Target cases for case report form collection: All patients from among the target cases for enrollment who use HERCEPTIN.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main survey items etc. 1) Information on facilities: Name of facility, name of department, case report form entry date, name of physician who fills out the case report form 2) Patient demographics: Patient initials, age at administration start, sex, pregnancy status, identification number, reason for use (if used for this indication, HER2 over expression or gene amplifications test results), name of clinical diagnosis, height, weight, performance status (ECOG PS), malignancy, stage classification at initial diagnosis, treatment line, presence / absence of metastatic lesions at the time of administration of HERCEPTIN, if present: metastatic site, previous medical history, complications 3) Prior treatment history: Details of surgery for the primary disease, if performed. Irradiation method, if radiation therapy for the primary disease was undertaken. Name of medications, if chemotherapy for the primary disease was undertaken. 4) Administration status of HERCEPTIN. Administration date, amount in a single dose, status of HERCEPTIN at the end of the observation period (ongoing, temporarily suspended, discontinued [if discontinued, reason for discontinuation]) 5) Combination chemotherapy (docetaxel preparation): Administration date, amount in a single dose 6) If adverse events occur: Name of adverse event, date of onset, grade at the worst point, severity, treatment (HERCEPTIN, other), outcome, date of outcome, causal relationship (HERCEPTIN, other cause), laboratory test values related to the safety specifications among adverse events, co-suspect drugs related to the adverse event	—

Measure

Time frame

Main survey items etc. 1) Information on facilities: Name of facility, name of department, case report form entry date, name of physician who fills out the case report form 2) Patient demographics: Patient initials, age at administration start, sex, pregnancy status, identification number, reason for use (if used for this indication, HER2 over expression or gene amplifications test results), name of clinical diagnosis, height, weight, performance status (ECOG PS), malignancy, stage classification at initial diagnosis, treatment line, presence / absence of metastatic lesions at the time of administration of HERCEPTIN, if present: metastatic site, previous medical history, complications 3) Prior treatment history: Details of surgery for the primary disease, if performed. Irradiation method, if radiation therapy for the primary disease was undertaken. Name of medications, if chemotherapy for the primary disease was undertaken. 4) Administration status of HERCEPTIN. Administration date, amount in a single dose, status of HERCEPTIN at the end of the observation period (ongoing, temporarily suspended, discontinued [if discontinued, reason for discontinuation]) 5) Combination chemotherapy (docetaxel preparation): Administration date, amount in a single dose 6) If adverse events occur: Name of adverse event, date of onset, grade at the worst point, severity, treatment (HERCEPTIN, other), outcome, date of outcome, causal relationship (HERCEPTIN, other cause), laboratory test values related to the safety specifications among adverse events, co-suspect drugs related to the adverse event

—

Countries

Japan

Contacts

Public ContactAyako Murayama

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

murayamaayk@chugai-pharm.co.jp03-3281-6611

Outcome results