Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by TTY Biopharm.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
TTY Biopharm
ClinicalTrials.gov Identifier:
NCT01451580
First received: October 11, 2011
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: Lipo-Dox
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TTY Biopharm:

Estimated Enrollment: 47
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically proved breast cancer with metastatic disease

Exclusion Criteria:

  • life expectancy less than 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01451580     History of Changes
Other Study ID Numbers: LD0411
Study First Received: October 11, 2011
Last Updated: October 12, 2011
Health Authority: Taiwan: Department of Health

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
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 28, 2014