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

Tianjin Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Abraxane

Study type: Interventional

Funder types: Other

Identifiers

NCT01647672

aesa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Abraxane

Experimental group

Description:

Abraxane for neoadjuvant chemotherapy

Treatment:

Drug: Abraxane