Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
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
Intervention
Name: Abraxane
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
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
Location
Tianjin Cancer Hospital
Tianjin, Tianjin, China
Status: Recruiting
Contact: ZHANG SHENG, DOCTOR - 86-022-23340123
Start Date
January 2012
Completion Date
December 2013
Sponsors
Tianjin Medical University
Source
Tianjin Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page