臨床研究等提出・公開システム

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

780

Baseline patient demographics and disease characteristics were generally well balanced between treatment groups.

A total of 780 participants were randomly assigned to receive either pertuzumab plus trastuzumab and chemotherapy (pertuzumab group, n=388) or placebo plus trastuzumab and chemotherapy (control group, n=392).

Safety was generally similar between the treatment groups; the rates of grade 3 or worse diarrhoea, hypokalaemia, and nausea adverse events were increased in the pertuzumab versus control group.

Overall survival (Median [95% CI]) Pertuzumab group:17.5 months [16.2-19.3] Control group: 14.2 months [12.9-15.5]

Progression-free survival(Median [95% CI]) Pertuzumab group: 8.5 months [8.2-9.7] Control group: 7.0 months [6.4-8.2]

Adding pertuzumab to trastuzumab and chemotherapy did not significantly improve overall survival in patients with HER2-positive metastatic gastric or gastro-oesophageal junction cancer compared with placebo.

Sept. 11, 2018

https://pubmed.ncbi.nlm.nih.gov/30217672/

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp

completed

July. 10, 2013

Interventional

Double-blind, placebo-controlled, randomized, multicenter study

treatment purpose

3

- HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction
- Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy >/= 3 months

- Previous cytotoxic chemotherapy for advanced (metastatic) disease
- Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
- Previous treatment with any HER2-directed therapy, at any time, for any duration
- Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
- Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to peripheral bone metastases, if recovered from all toxicities)
- History or evidence of brain metastases
- Clinically significant active GI bleeding (Grade >/= 2 according to NCI-CTCAEv.4.03)
- Other malignancy (in addition to GC) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
- Inadequate hematologic, renal or liver function
- Pregnant or lactating women
- History of congestive heart failure of any New York Heart Association (NYHA) criteria
- Angina pectoris requiring treatment
- Myocardial infarction within the past 6 months before the first dose of study drug
- Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
- History or evidence of poorly controlled hypertension
- Baseline left ventricular ejection fraction (LVEF) value < 55%
- Any significant uncontrolled intercurrent systemic illness
- Positive for hepatitis B, hepatitis C or HIV infection

Both

HER2-positive metastatic gastroesophageal junction or gastric cancer

investigational material(s)
Generic name etc : pertuzumab
INN of investigational material : pertuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 840 mg iv every 3 weeks

control material(s)
Generic name etc : pertuzumab placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : iv every 3 weeks

efficacy
Overall survival
Time from randomization to death of any cause

safety
efficacy
pharmacokinetics
other
Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause
Overall objective response (partial response + complete response) : Response occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria
Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause
Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria
Safety: Incidence of adverse events and left ventricular systolic dysfunction (symptomatic or asymptomatic)

April. 09, 2013