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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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