Know Cancer

or
forgot password

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


Phase 2/Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

therapeutic assessment

Outcome Description:

therapeutic assessment

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jin Zhang, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin Cancer hospital

Authority:

China: Ministry of Health

Study ID:

aesa

NCT ID:

NCT01647672

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location