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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: Abraxane

• Registration Number: NCT01647672
• Lead Sponsor: Tianjin Medical University

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 Timeline

• Study Start: 2012-01
• Status Verified: 2012-07
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-23
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abraxane	Abraxane	Abraxane for neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
therapeutic assessment	6 months	therapeutic assessment

Secondary Outcome Measures

Name	Time	Method
Adverse reactions and disease-free survival	2 year	Adverse reactions during the treatment and disease-free survival

Trial Locations

Locations (1)

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China