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
Overview
- Phase
- Phase 2
- Intervention
- Abraxane
- Conditions
- Breast Cancer
- Sponsor
- Tianjin Medical University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- therapeutic assessment
- Last Updated
- 13 years ago
Overview
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.
Investigators
Zhang jin
Professor
Tianjin Medical University
Eligibility Criteria
Inclusion Criteria
- •Karnofsky ≥ 70
- •Provision of informed consent
- •Pathological confirmation of breast cancer
- •Tumor stage (TNM):T2-4bN0-3M0
- •Measurable disease as per RECIST criteria
- •Not previously treated with radiotherapy, chemotherapy or biological therapy.
- •Laboratory criteria:
- •PLT ≥ 100\*109/L
- •WBC ≥ 4000/mm3
- •HGB ≥ 10g/dl
Exclusion Criteria
- •Pregnant woman
- •History of organ transplantation
- •With mental disease
- •With severe infection or active gastrointestinal ulcers
- •With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
- •Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ)
- •With heart disease
- •Experimental drug allergy
Arms & Interventions
Abraxane
Abraxane for neoadjuvant chemotherapy
Intervention: Abraxane
Outcomes
Primary Outcomes
therapeutic assessment
Time Frame: 6 months
therapeutic assessment
Secondary Outcomes
- Adverse reactions and disease-free survival(2 year)