Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.

Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy. - JBCRG-C02

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002738

Enrollment

100

Registered

2009-11-11

Start date

2009-07-03

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

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients who meet ALL the following criteria are eligible: (1)Agreed to receive trastuzumab for recurrent breast cancer (2)Prior Registration into JBCRG C-01 (3)Must have received for at least 10 months of approved (neo) trastuzumab adjuvant therapy (4)Have evaluable lesion (5)Untreated for recurrence (6)LVEF >50% within 28days prior to registration. (7)Signed written informed consent

Exclusion criteria

Exclusion criteria: Patients who meet ANY ONE of the following criteria are NOT eligible: (1)History of hypersensitivity to trastuzumab (2)Patients who are pregnant, lactating or with possibility of pregnancy (3)Stage IV at the first diagnosis (4)Patients with brain metastasis (5)Patients who were decided ineligible to this study from an investigator.

Design outcomes

Primary

Measure	Time frame
Progression-free survival; PFS	—

Secondary

Measure	Time frame
Response rate, overall survival, safety	—

Countries

Japan

Contacts

Public ContactKatsumasa Kuroi

Japan Breast Cancer Research Group (JBCRG) Head Office

office@jbcrg.jp03-6264-8873

Outcome results