COMACHI

A post-marketing clinical study to evaluate the efficacy and safety of pertuzumab combined with trastuzumab and docetaxel as first line treatment in HER2- positive inoperable or recurrent breast cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080222272

Enrollment

130

Registered

2013-10-30

Start date

2013-11-11

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

HER2- positive inoperable or recurrent breast cancer

Interventions

investigational material(s) Generic name etc : pertuzumab (PERJETA) INN of investigational material : pertuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for In

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - HER2 positive (IHC 3+ or ISH-positive) - cancer of the breast, with inoperable or recurrent disease, and candidate for chemotherapy - ECOG performance status 0 or 1.

Exclusion criteria

Exclusion criteria: - History of anticancer therapy (any EGFR or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen) for inoperable or recurrent breast cancer. - History of tyrosine kinase/HER family inhibitors for breast cancer, except trastuzumab used in the neoadjuvant or adjuvant setting - History of systemic breast cancer treatment in the neoadjuvant or adjuvant setting with a disease-free interval from completion of the taxane in the neoadjuvant or adjuvant setting to recurrent diagnosis of < 12 months - CNS metastases - Clinically relevant cardiovascular disease

Design outcomes

Secondary

Measure	Time frame
efficacy safety 1. Overall survival 2. Objective response rate 3. Duration of objective response 4. Safety 1. Time from the first dose to death of any cause 2. Rate of response occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST ver 1.1. 3. Time from occurrence of CR or PR to progressive disease, as determined by investigator according to RECIST ver 1.1, or death of any cause 4. Incidence of adverse events and abnormal laboratory values	—

Measure

Time frame

efficacy safety 1. Overall survival 2. Objective response rate 3. Duration of objective response 4. Safety 1. Time from the first dose to death of any cause 2. Rate of response occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST ver 1.1. 3. Time from occurrence of CR or PR to progressive disease, as determined by investigator according to RECIST ver 1.1, or death of any cause 4. Incidence of adverse events and abnormal laboratory values

—

Primary

Measure	Time frame
efficacy Progression free survival Time from the first dose to the first documented radiographic progressive disease, as determined by the investigator using RECIST ver 1.1, or death from any cause, whichever comes first.	—

Countries

Japan

Outcome results

None listed

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