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

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

Overview[ - collapse ][ - ]

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	Breast Cancer
Intervention	Drug: Abraxane
Phase	Phase 2/Phase 3
Sponsor	Tianjin Medical University
Responsible Party	Tianjin Medical University
ClinicalTrials.gov Identifier	NCT01647672
First Received	July 18, 2012
Last Updated	July 24, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	July 18, 2012
Last Updated Date	July 24, 2012
Start Date	January 2012
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	therapeutic assessment [Time Frame: 6 months] [Designated as safety issue: Yes]therapeutic assessment
Current 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

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer
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
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.
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 Type	Interventional
Study Phase	Phase 2/Phase 3
Study Design	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Breast Cancer
Intervention	Drug: Abraxane Abraxane for neoadjuvant chemotherapy Other Names: Abraxane
Study Arm (s)	Experimental: Abraxane Abraxane for neoadjuvant chemotherapy

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	60
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2012
Eligibility 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 ≥ 100109/L - WBC ≥ 4000/mm3 - HGB ≥ 10g/dl - GOT,GPT,ALP ≤ 2ULN - 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
Gender	Female
Ages	N/A
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01647672
Other Study ID Numbers	aesa
Has Data Monitoring Committee	Yes
Information Provided By	Tianjin Medical University
Study Sponsor	Tianjin Medical University
Collaborators	Not Provided
Investigators	Study Chair: Jin Zhang, Professor Tianjin Cancer hospital
Verification Date	July 2012

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