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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Tianjin Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhang jin, Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT01647672
First received: July 18, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Abraxane
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University:

Primary Outcome Measures:
  • therapeutic assessment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    therapeutic assessment


Secondary Outcome Measures:
  • Adverse reactions and disease-free survival [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    Adverse reactions during the treatment and disease-free survival


Other Outcome Measures:
  • Recurrence or death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Recurrence or death


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abraxane
Abraxane for neoadjuvant chemotherapy
Drug: Abraxane
Abraxane for neoadjuvant chemotherapy
Other Name: Abraxane

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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Zhang jin, Professor, Tianjin Medical University
ClinicalTrials.gov Identifier: NCT01647672     History of Changes
Other Study ID Numbers: aesa
Study First Received: July 18, 2012
Last Updated: July 24, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014