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Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer

NCT02229149 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-12-02

No results posted yet for this study

Summary

This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane \[paclitaxel, docetaxel or nab paclitaxel\] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.

Conditions

  • Breast Neoplasms
  • Malignant Tumor of the Breast

Interventions

DRUG

Trastuzumab

Treatment for all patients will consist of trastuzumab, given as a loading dose of 8 mg/kg IV on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter. Patients randomized to the chemotherapy plus trastuzumab arm (without pertuzumab) can receive trastuzumab 6 mg/kg IV every 3 weeks if they are receiving docetaxel or capecitabine on a 3-week cycle, or 4 mg/kg IV every 2 weeks if they are receiving vinorelbine, paclitaxel, or nab-paclitaxel on a 4-week cycle. The loading dose for all patients remains 8 mg/kg. For patients randomized to the chemotherapy plus trastuzumab plus pertuzumab arm, both trastuzumab and pertuzumab need to be administered every 3 weeks regardless of which chemotherapy agent they are receiving.

DRUG

Pertuzumab

pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.

DRUG

Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine

physician's choice of chemotherapy: * Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR * Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR * Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR * Docetaxel 75 mg/m2 IV every 3 weeks; OR * Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Neelima Denduluri, MD · US Oncology Research, McKesson Specialty Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States

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Entities

Drugs

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 NCT02229149 on ClinicalTrials.gov