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Trial record 23 of 2157 for:    doxorubicin

Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in 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: NCT03221881
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pegylated Liposomal Doxorubicin and docetaxel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Breast Cancer.
Actual Study Start Date : January 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Pegylated Liposomal Doxorubicin and docetaxel
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
Other Name: 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.




Primary Outcome Measures :
  1. PCR rate [ Time Frame: 12 months ]
    pathologic complete response rate



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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:

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

Exclusion Criteria:

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

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): NCT03221881


Locations
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China, Beijing
MRI
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Shan Baoen Investigator

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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03221881     History of Changes
Other Study ID Numbers: CSPC-DMS-BC-01
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors