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Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

NCT02402712 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2019-09-06

No results posted yet for this study

Summary

This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

Conditions

Interventions

DRUG

Docetaxel

Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.

DRUG

pertuzumab [Perjeta]

Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg

DRUG

trastuzumab [Herceptin]

Subcutaneous administration of 600 mg/5 mL every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-06
Primary Completion
2019-02-22
Completion
2019-02-22

Countries

  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02402712 on ClinicalTrials.gov