Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer
Sponsor
TTY Biopharm (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01451580
Collaborator
(none)
47
1
Study Details
Study Description
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 |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Sep 1, 2005
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- histologically proved breast cancer with metastatic disease
Exclusion Criteria:
- life expectancy less than 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CGMH | Linko | Taiwan |
Sponsors and Collaborators
- TTY Biopharm
Investigators
- Principal Investigator: Hsien-Kun Chang, Chang Gung Memorial Hospital, Lin-Kou Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01451580
Other Study ID Numbers:
- LD0411
First Posted:
Oct 13, 2011
Last Update Posted:
Oct 13, 2011
Last Verified:
Oct 1, 2011
Keywords provided by ,
,
Additional relevant MeSH terms: