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Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

NCT01835236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2021-03-30

No results posted yet for this study

Summary

In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

Conditions

Interventions

DRUG

Trastuzumab

First administration (loading dose) 8 mg/kg i.v. infusion over 90 min. \- then every 3 weeks until progression 6 mg/kg i.v. infusion over 30 to 90 min.

DRUG

Pertuzumab

First administration (loading dose) 840 mg i.v. infusion over 60 min. \- then every 3 weeks until progression 420 mg i.v. infusion over 30 to 60 min.

DRUG

Paclitaxel

Day 1, 8 and 15; every 4 weeks for ≥4 months 90 mg/m2 i.v. infusion

DRUG

Vinorelbine

First administration: Day 1 and 8 25 mg/m2 i.v. infusion * then day 1 and 8, every 3 weeks for ≥4 months 30 mg/m2 i.v. infusion

DRUG

T-DM1

Every 3 weeks until unacceptable toxicity or progressive disease is observed 3.6 mg/kg i.v. infusion First dose: over 90 min (± 10 min.) Subsequent doses: over 30 min. (± 10 min.)

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Jens Huober, MD · University of Ulm

  • Patrik Weder, MD · Cantonal Hospital of St. Gallen

  • Hervé Bonnefoi, Prof · Institut Bergonié Bordeaux

  • Epie Boven, MD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-03
Primary Completion
2018-01-11
Completion
2020-05-26

Countries

  • France
  • Germany
  • Netherlands
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

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 NCT01835236 on ClinicalTrials.gov