NCT02903524

Brief Summary

Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 13, 2016

Last Update Submit

September 15, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • pathological complete response

    until the completion of 4 cycles (each cycle is 21 days) of chemotherapy

Study Arms (2)

control group

ACTIVE COMPARATOR

Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy

Drug: pirarubicin and cyclophosphamide

Experimental group

EXPERIMENTAL

Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy

Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide

Interventions

Doxorubicin Hydrochloride Liposome injection and cyclophosphamideDRUG
Experimental group
pirarubicin and cyclophosphamideDRUG
control group

Eligibility Criteria

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

You may qualify if:

  • Female patients with age between 18 and 70 years.
  • Newly diagnosed breast cancer, stages IIb-IIIc.
  • KPS performance status≥70.
  • Measurable disease according to RECIST version 1.1.
  • Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
  • Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
  • Adequate hepatic and renal function.
  • AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
  • Serum creatinine≥44 µmol/L and ≤133 µmol/L.
  • Written informed consent are acquired.
  • Not in pregnancy or the pregnancy tests of females is negative.

You may not qualify if:

  • Severe heart failure (NYHA grade II or higher).
  • Active and uncontrolled severe infection.
  • Have accepted any other anti-tumor drug within 30 days before the first dose or
  • received radiation treatment.
  • Other situations that investigators consider as contra-indication for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050019, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamidepirarubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Geng Cuizhi, archiater

CONTACT

0311-66696310gengcuizhi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

CN(1)