Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study

Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study - Second-line Trastuzumab/Docetaxel combination therapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Beyond PD study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000264

Enrollment

Registered

2005-10-15

Start date

2003-02-01

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

Breast cancer

Interventions

Chemotherapy(Trastuzumab+Docetaxel)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Histologically confirmed mastocarcinoma Patients progriising on first line Trastuzumab monotherapy HER2 status of primary or metastatic tumour was assessed positive Measurable or evaluable lesion ECOG performance status 0,1 or 2 Age: 20-75 years old Ample organ function Signed informed consent

Exclusion criteria

Exclusion criteria: Documented history of serious hypersensitivity reaction on the medical drugs Severe complication Fever, suspicious of infection Severe pleural fluid and pericardial effusion Symptomatic brain metastasis Active double cancer Interstitial pneumonia or pulmonary fibrosis Neuropathy Grade 2,3 or 4 edema Pregnant or lactating women Doctor's decision for exclusion

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
Progression-free survival(PFS) Overall survival(OS) adverse event(AE)	—

Countries

Japan

Contacts

Public ContactNorikazu MASUDA

H/D study group on Breast Cancer Executive Office

06-6942-1331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026