Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

Takeda

Status: Completed

Conditions: Premenopausal Breast Cancer

Treatments: Drug: Leuprorelin acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT03209518

JapicCTI-163203 (Registry Identifier)

Leuprorelin-5003

Details and patient eligibility

About

The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

Full description

The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.

This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.

The survey will enroll approximately 300 patients.

• Leuprorelin

This multi-center survey will be conducted in Japan.

Enrollment: 312 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with premenopausal breast cancer will be included.

Exclusion criteria

• Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
• Pregnant or potentially pregnant participants and breastfeeding participants

Trial design

312 participants in 1 patient group

Leuprorelin acetate

Description:

Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.

Treatment:

Drug: Leuprorelin acetate