NCT03017404

Brief Summary

To study the maximum tolerated dose of Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable breast-cancer

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

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 9, 2017

Last Update Submit

January 10, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • maximum tolerated dose

    4 cycles (each cycle is 21 days) of chemotherapy

Study Arms (4)

treatment group:35 mg/m(2)

EXPERIMENTAL

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Drug: Doxorubicin Hydrochloride Liposome InjectionDrug: CyclophosphamideDrug: docetaxel

treatment group:40 mg/m(2)

EXPERIMENTAL

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Drug: Doxorubicin Hydrochloride Liposome InjectionDrug: CyclophosphamideDrug: docetaxel

treatment group:45 mg/m(2)

EXPERIMENTAL

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Drug: Doxorubicin Hydrochloride Liposome InjectionDrug: CyclophosphamideDrug: docetaxel

treatment group:50 mg/m(2)

EXPERIMENTAL

Doxorubicin Hydrochloride Liposome injection combination with cyclophosphamide and sequential treatment of docetaxel, 4 cycles (each cycle is 21 days) of chemotherapy

Drug: Doxorubicin Hydrochloride Liposome InjectionDrug: CyclophosphamideDrug: docetaxel

Interventions

Doxorubicin Hydrochloride Liposome InjectionDRUG
treatment group:35 mg/m(2)treatment group:40 mg/m(2)treatment group:45 mg/m(2)treatment group:50 mg/m(2)
CyclophosphamideDRUG
treatment group:35 mg/m(2)treatment group:40 mg/m(2)treatment group:45 mg/m(2)treatment group:50 mg/m(2)
docetaxelDRUG
treatment group:35 mg/m(2)treatment group:40 mg/m(2)treatment group:45 mg/m(2)treatment group:50 mg/m(2)

Eligibility Criteria

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

You may qualify if:

  • Female patients newly diagnosed breast cancer≥18 and ≤70 years of age;
  • Karnofsky performance status≥70 and measurable or evaluable;
  • Stages Ⅲa-ⅢC;
  • Baseline left ventricular ejection fraction (LVEF) ≥ 50%;
  • Adequate marrow function (WBC count\> 4.0×10(9)/L, neutrophil\> 2.0×10(9)/L, platelet count \> 100×10(9)/L，hemoglobin \> 90g/L );
  • AST and ALT ≤1.5× institutional upper limit of normal, alkaline phosphatase
  • ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal;
  • Serum creatinine ≥ 44µmol/L and ≤ 133 µmol/L;
  • Expected lifetime ≥ 12 months;
  • Pregnancy tests of reproductive age women is negative;
  • All patients provided written informed consent.

You may not qualify if:

  • Distant metastasis;
  • Severe heart failure (NYHA grade II or higher);
  • Active and uncontrolled severe infection;
  • Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel;
  • Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin;
  • Pregnancy or breast feeding;
  • 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

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CyclophosphamideDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 11, 2017

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

CN(1)