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Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer

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ClinicalTrials.gov Identifier: NCT01647672
Recruitment Status : Unknown
Verified July 2012 by Zhang jin, Tianjin Medical University.
Recruitment status was:  Recruiting
First Posted : July 23, 2012
Last Update Posted : July 25, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Abraxane Phase 2 Phase 3

Detailed Description:
The investigators select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess the Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in the Treatment of Operable Breast Cancer
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Abraxane
Abraxane for neoadjuvant chemotherapy
Drug: Abraxane
Abraxane for neoadjuvant chemotherapy


Outcome Measures

Primary Outcome Measures :
  1. therapeutic assessment [ Time Frame: 6 months ]
    therapeutic assessment


Secondary Outcome Measures :
  1. Adverse reactions and disease-free survival [ Time Frame: 2 year ]
    Adverse reactions during the treatment and disease-free survival


Other Outcome Measures:
  1. Recurrence or death [ Time Frame: 5 years ]
    Recurrence or death


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Karnofsky ≥ 70
  2. Provision of informed consent
  3. Pathological confirmation of breast cancer
  4. Tumor stage (TNM):T2-4bN0-3M0
  5. Measurable disease as per RECIST criteria
  6. Not previously treated with radiotherapy, chemotherapy or biological therapy.
  7. Laboratory criteria:

    • PLT ≥ 100*109/L
    • WBC ≥ 4000/mm3
    • HGB ≥ 10g/dl
    • GOT,GPT,ALP ≤ 2*ULN
    • TBIL,DBIL,CCr ≤ 1.5*ULN

Exclusion Criteria:

  1. Pregnant woman
  2. History of organ transplantation
  3. With mental disease
  4. With severe infection or active gastrointestinal ulcers
  5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
  6. Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ)
  7. With heart disease
  8. Experimental drug allergy
Contacts and Locations

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): NCT01647672


Locations
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: ZHANG SHENG, DOCTOR    86-022-23340123 ext 2901      
Contact: ZHANG SHENG, DORTOR    86-022-23340123 ext 2901      
Principal Investigator: ZHANG JIN, PROFESSOR         
Sponsors and Collaborators
Tianjin Medical University
Investigators
Study Chair: Jin Zhang, Professor Tianjin Cancer hospital
More Information

Responsible Party: Zhang jin, Professor, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01647672     History of Changes
Other Study ID Numbers: aesa
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action