advanced or recurrent breast cancer
Conditions
Interventions
Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses.In case with paclitaxel,Trastusumab with a sta
Sponsors
Shonankamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed advancer (stave IIIB,IIIC,IV) or recurrent breast cancer. 2) Her2 positive breast cancer 3) Patient with history of Trasutuzumab treatment. 4) Patient without prior Pertuzumab treatment. 5) Patient with lesion confirmed by imaging tests 6) Patient with ECOG performance satis 0 or 1 7) Age 18 to 80 yeas old. 8) Patients with adequately maintained organ and bone marrow functions. 9) Any sex 19) Patients who provided written informed consent by themselves in principle to participate in this trial.
Exclusion criteria
Exclusion criteria: 1) Patient with history of severe allergy. 2) Patient with history of Pertuzumab treatment. 3) Patient with other malignancy under treatment. 4) Patient with active infectious disease. 5) Patient with severe complications, 6) Patient with history of interstitial neumonitis to pulmonary fibrosis. 7) Patient with uncontrollable pleural effusion or ascites. 8) Patient with symptomatic brain metastasis. 9) Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception. 10) Patient with psychiatric disease who were considered to be inappropriate. 11)Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Duration of treatment without taxane Safety | — |
Countries
Japan
Contacts
Public ContactRai Shimoyama
Shonankamakura General Hospital Clinical Research Center
Outcome results
None listed