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
 Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
 Recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
 Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy N/A
 Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
 Active, not recruiting NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan. N/A
 Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
 Recruiting NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer Phase 2
 Recruiting NCT02739425 - The Efficacy of Sentimag in Detection of Sentinel Node Biopsy N/A
 Not yet recruiting NCT02767661 - Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer Phase 3
 Not yet recruiting NCT03176888 - Health Benefits of HIT for Breast Cancer Patients N/A
 Not yet recruiting NCT03197805 - Assessment of the Impact of RNA Genomic Profile on Treatment Decision-making in HER2 Equivocal Breast Cancer Patients N/A
 Recruiting NCT03080155 - A Study of the 3D MIRA System in Classifying Women at for Likelihood of Breast Cancer N/A
 Recruiting NCT02689427 - Phase IIB Neoadjuvant Enzalutamide (ZT) Plus Taxol for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer (AR+ TNBC) Phase 2
 Recruiting NCT02980848 - Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study N/A
 Recruiting NCT02035085 - 19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction Phase 1
 Recruiting NCT02909751 - Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer Phase 2
 Recruiting NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant Phase 2
 Recruiting NCT02897050 - Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer Phase 2
 Recruiting NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation N/A
 Recruiting NCT02840344 - Couples-Based Mindfulness for Young Breast Cancer Survivors N/A