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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01647672
• Other study ID #: aesa
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 18, 2012
• Last updated: July 24, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Abraxane
Abraxane for neoadjuvant chemotherapy

Locations

Country	Name	City	State
China	Tianjin Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrence or death	Recurrence or death	5 years	Yes
Primary	therapeutic assessment	therapeutic assessment	6 months	Yes
Secondary	Adverse reactions and disease-free survival	Adverse reactions during the treatment and disease-free survival	2 year	Yes