A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer

ClinicalTrials.gov ID: NCT01565083

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Official title

A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.

Study identification

NCT ID: NCT01565083
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 213 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

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: Apr 2012 (Type not available)
Primary completion: Oct 2015 (Actual)
Completion: Oct 2015 (Actual)
Last update posted: Nov 22, 2016

2012 – 2015

United States locations

U.S. sites: 17
U.S. states: 13
U.S. cities: 16

Facility	City	State	ZIP	Site status
Not listed	Tucson	Arizona	85724	—
Not listed	Stanford	California	94305-5151	—
Not listed	Denver	Colorado	80220	—
Not listed	Hollywood	Florida	33021	—
Not listed	Miami	Florida	33136	—
Not listed	Plantation	Florida	33324	—
Not listed	Marietta	Georgia	30060	—
Not listed	Boston	Massachusetts	02215	—
Not listed	Morristown	New Jersey	07960	—
Not listed	Durham	North Carolina	27710	—
Not listed	Columbus	Ohio	43210	—
Not listed	Houston	Texas	77090	—
Not listed	San Antonio	Texas	78229	—
Not listed	Ogden	Utah	84403	—
Not listed	Fredericksburg	Virginia	22408	—
Not listed	Seattle	Washington	98101	—
Not listed	Seattle	Washington	98195	—

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 63 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01565083, 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 Nov 22, 2016 · Synced Nov 14, 2026