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NCT01597414 (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1 (NCT01597414)

Trial Description
Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.

The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.

This trial is sponsored by European Organisation for Research and Treatment of Cancer  (EORTC) / F. Hoffmann-La Roche. [1]

Study Data

  • Condition: Elderly Metastatic Breast Cancer
  • Interventions:
  • Phase: II
  • Estimated Enrollment: 80
  • Start: June 2013
  • Estimated Primary Completion: November 2016
  • Last verified: January 2015

Study Schematic

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* The name metronomic comes from the idea of regular administration of chemotherapeutic drugs.

The concept of Metronomic Chemotherapy or MCT, which is intended to prevent tumor angiogenesis, is based on research by Douglas Hanahan, Judah Folkman and Robert Kerbel and their respective colleagues. This approach stand in contradiction to traditional chemotherapy regimens which generally call for higher doses of chemotherapy and are often limited largely by the body’s own capacity to handle the adverse events as well as for limited campaigns of several weeks in order to avoid drug resistance and avoid harming the body’s organs beyond a certain limit. Hence, metronomic chemotherapy, which uses conventional cytotoxic drugs but counts on them to stop or slow blood vessel growth, makes reference to the chronic, equally spaced administration of low doses of various chemotherapeutic drugs without extended rest periods between cycles of therapy (a practice that may not only involve re-growth of tumour cells, but also growth of selected clones resistant to the therapy).[2][3]

Metronomic Chemotherapy (MCT) contrasts the Maximum Tolerated Dose (MTD) method typically used in most clinical protocols.[2]

Last Editorial review: July 30, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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