CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,436 enrolled
Drug / intervention
Docetaxel +4 moredrug
Likely dose
Pertuzumab 840 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01572038
NCT01572038Phase 3Completed
CompareCT.gov

A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

Hoffmann-La Roche·interventional·Posted Apr 5, 2012·Updated Sep 25, 2020

In Brief

A Phase 3 clinical trial evaluating Docetaxel, Nab-paclitaxel, and 3 other interventions for Breast Neoplasms. Completed, enrolled 1,436 participants across 299 sites in 39 countries.

Detailed Summary

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAlgeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Lebanon, Lithuania, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 5, 2012
Enrollment StartJun 1, 2012
Primary CompletionSep 20, 2019
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 14.2 years ago

Interventions

Docetaxeldrug

Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Nab-paclitaxeldrug

Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Paclitaxeldrug

Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Pertuzumabdrug

Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.

Trastuzumabdrug

Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.