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A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection for Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017404
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Doxorubicin Hydrochloride Liposome Injection Drug: Cyclophosphamide Drug: docetaxel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Increase Finding Study of Doxorubicin Hydrochloride Liposome Injection in Neoadjuvant Chemotherapy for Patients With Locally Advanced Breast Cancer
Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: treatment group:35 mg/m(2)
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 Injection
Drug: Cyclophosphamide
Drug: docetaxel
Experimental: treatment group:40 mg/m(2)
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 Injection
Drug: Cyclophosphamide
Drug: docetaxel
Experimental: treatment group:45 mg/m(2)
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 Injection
Drug: Cyclophosphamide
Drug: docetaxel
Experimental: treatment group:50 mg/m(2)
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 Injection
Drug: Cyclophosphamide
Drug: docetaxel



Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 4 cycles (each cycle is 21 days) of chemotherapy ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017404


Locations
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China, Hebei
Fourth Hospital of Hebei Medical University
Shi Jiazhuang, Hebei, China, 050019
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03017404    
Other Study ID Numbers: CSPC-DMS-BC-02
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors