A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
Public ClinicalTrials.gov record NCT01774786. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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 and Gastric Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram \[mg/kg\] intravenously \[IV\] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Study identification
- NCT ID
- NCT01774786
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 780 participants
Conditions and interventions
Conditions
Interventions
- 5-Fluorouracil Drug
- Capecitabine Drug
- Cisplatin Drug
- Pertuzumab Drug
- Placebo Drug
- Trastuzumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 10, 2013 (Actual)
- Primary completion
- Dec 9, 2016 (Actual)
- Completion
- Dec 31, 2019 (Actual)
- Last update posted
- Dec 30, 2020
2013 – 2019
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Cancer Specialists - SCRI; Pharmacy | Fort Myers | Florida | 33901 | — |
| University Of Chicago Medical Center; Section Of Hematology/Oncology | Chicago | Illinois | 60637 | — |
| Indiana University Health; Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| Queens Medical Associates | Fresh Meadows | New York | 11366 | — |
| Weill Medical College of Cornell University; Division of Hematology & Medical Oncology | New York | New York | 10065 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45219 | — |
| Medical University of South Carolina; Hollings Cancer Center | Charleston | South Carolina | 29425 | — |
| Tennessee Oncology PLLC - Nashville (20th Ave) | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 162 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01774786, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 30, 2020 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01774786 live on ClinicalTrials.gov.