NCT00465673

Brief Summary

Primary objective: To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis Secondary objectives:

  1. 1.To determine the overall objective response rate (ORR)
  2. 2.To determine the progression free survival, and duration of objective response
  3. 3.To evaluate the overall survival (OS)
  4. 4.To assess the safety profiles

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

3.8 years

First QC Date

April 23, 2007

Last Update Submit

August 4, 2009

Conditions

Breast Cancer

Keywords

breast cancerbrain metastatsisLipo-Dox

Outcome Measures

Primary Outcomes (1)

  • Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis

    3 years

Secondary Outcomes (4)

  • To determine the overall objective response rate

    3 years

  • To determine the progression free survival, and duration of objective response

    3 years

  • To evaluate the overall survival

    3 years

  • To assess the safety profiles

    3 years

Interventions

Liposomal DoxorubicinDRUG

40mg/m2 over 1 hour infusion for 21 days

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proved breast cancer
  • Relapse/recurrent brain metastasis progression after brain radiotherapy
  • Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI)
  • Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed
  • Performance status of ECOG 0, 1, 2
  • With normal left ventricular ejection fraction and normal ventricular contractility
  • Age 21 years or older
  • Life expectancy equal or longer than 3 months
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin
  • Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study
  • Prior liposomal doxorubicin treatment
  • Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
  • Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
  • Brain metastases defined as meninges metastases
  • Presence of serious concomitant illness which might be aggravated by study medication:
  • Uncontrolled infection (active serious infections that are not controlled by antibiotics)
  • Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
  • History of ventricular arrhythmia or congestive heart failure.
  • Presence of abnormal left ventricular ejection fraction
  • Hematopoietic function as defined below:
  • Hemoglobin\<10g/dl
  • ANC\< 1,500/uL
  • Platelets\<100,000/uL
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Singapore International Medical Center

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alex Chang

    Johns Hopkins SIngapore International Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

September 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

SG(1)