NCT03221881

Brief Summary

In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

June 22, 2017

Last Update Submit

July 15, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PCR rate

    pathologic complete response rate

    12 months

Study Arms (1)

Pegylated Liposomal Doxorubicin and docetaxel

EXPERIMENTAL

Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.

Drug: Pegylated Liposomal Doxorubicin and docetaxel

Interventions

Pegylated Liposomal Doxorubicin and docetaxelDRUG
Also known as: Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.
Pegylated Liposomal Doxorubicin and docetaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed breast cancer;
  • Age \>18 years;
  • Eastern Cooperative Group (ECOG) performance status 0-2;
  • measurable disease (as per radiological imaging); life
  • expectancy \>12 months;
  • adequate haematologic blood profile;
  • normal liver and kidney function;
  • adequate cardiac function;
  • no metastatic disease;
  • negative pregnancy test (premenopausal women);
  • signed informed consent.

You may not qualify if:

  • Level 2 cardiac toxic effects were defined as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ;
  • Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures);
  • Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRI

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Shan Baoen

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

July 19, 2017

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)