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Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic 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: NCT01451580
Recruitment Status : Unknown
Verified October 2011 by TTY Biopharm.
Recruitment status was:  Recruiting
First Posted : October 13, 2011
Last Update Posted : October 13, 2011
Sponsor:
Information provided by:
TTY Biopharm

Brief Summary:
To determine the overall objective response rate of pegylated liposomal doxorubicin (Lipo-Dox)combined with cyclophosphamide/5-FU as second-line treatment in patients with metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Lipo-Dox Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase II Study of Pegylated Liposomal Doxorubicin (Lipo-Dox) Combined With Cyclophosphamide /5-Fluorouracil as Second Line Chemotherapy in the Treatment of Metastatic Breast Cancer
Study Start Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically proved breast cancer with metastatic disease

Exclusion Criteria:

  • life expectancy less than 3 months.

Information from the National Library of Medicine

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): NCT01451580


Locations
Taiwan
CGMH Recruiting
Linko, Taiwan
Contact: Wang, AN    +8862-2545-3105    monicachang@tty.com.tw   
Principal Investigator: Chang         
Sponsors and Collaborators
TTY Biopharm
Investigators
Principal Investigator: Hsien-Kun Chang Chang Gung Memorial Hospital, Lin-Kou Medical Center

ClinicalTrials.gov Identifier: NCT01451580     History of Changes
Other Study ID Numbers: LD0411
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by TTY Biopharm:
Phase II
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Liposomal doxorubicin
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors