Myocet Plus Endoxan for Older Patients With Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01120171|
Recruitment Status : Terminated (Due to poor accrual)
First Posted : May 10, 2010
Last Update Posted : October 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Cyclophosphamide Drug: Liposomal-encapsulated doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.
Therapy will continue until maximum response,or unacceptable toxicity.
Other Name: EndoxanDrug: Liposomal-encapsulated doxorubicin
Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days.
Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.
Therapy will continue until maximum response or unacceptable toxicity.
Other Name: Myocet
- Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ]
- Toxicity profile [ Time Frame: Toxicity assessment every month ]
- Time to Tumor Progression [ Time Frame: 1-year ]
- Overall Survival [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120171
|University General Hospital of Alexandroupolis|
|"IASO" General Hospital of Athens, 1st Dep of Medical Oncology|
|"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine|
|"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology|
|"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology|
|401 Military Hospital of Athens|
|Air Forces Military Hospital of Athens|
|University Hospital of Crete|
|State General Hospital of Larissa, Dep of Medical Oncology|
|"Diabalkaniko" hospital, Thessaloniki|
|: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology|
|Principal Investigator:||Dimitris Mavrudis, MD||University Hospital of Crete|