Clinical Trials Logo
NCT number NCT01120171
Study type Interventional
Source Hellenic Oncology Research Group
Contact
Status Terminated
Phase Phase 2
Start date September 2009
Completion date May 2015

Clinical Trial Summary

This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment


Clinical Trial Description

Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


See also
Status Clinical Trial Phase
 Not yet recruiting NCT02830685 - Pre-pectoral Breast Reconstruction PART 1 Phase 3
 Not yet recruiting NCT02875626 - Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer N/A
 Not yet recruiting NCT00960544 - Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Phase 2
 Not yet recruiting NCT02858934 - Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer N/A
 Not yet recruiting NCT02831426 - Pre-pectoral Breast Reconstruction PART 2 Phase 3
 Not yet recruiting NCT02861859 - A Randomized Trial of Individualised Care Versus Standard Care for Breast Cancer Patients at High Risk for Chemotherapy Induced Nausea and Vomiting. The ILIAD Study Phase 3
 Not yet recruiting NCT02871115 - Pilot Study of a Pharmacy Intervention for Older Adults With Cancer N/A
 Not yet recruiting NCT02784730 - Iterative PICC Placement Versus Long Term Device (PAC) in Oncology Phase 3
 Not yet recruiting NCT02850419 - Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer Patients Phase 2
 Not yet recruiting NCT02779751 - A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer Phase 2
 Not yet recruiting NCT02871167 - Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation N/A
 Recruiting NCT02547987 - Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer Phase 2
 Recruiting NCT02560818 - Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer N/A
 Recruiting NCT02466737 - Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery N/A
 Recruiting NCT02562118 - Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer Phase 1/Phase 2
 Recruiting NCT02694796 - Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy N/A
 Recruiting NCT02565017 - Examining Patient Preferences About the IBM Watson Oncology Clinical Decision Support System N/A
 Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
 Recruiting NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
 Recruiting NCT02630368 - A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX) Phase 1/Phase 2