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

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

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 Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Abraxane

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abraxane; Abraxane for neoadjuvant chemotherapy	Drug: Abraxane; Abraxane for neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
therapeutic assessment	therapeutic assessment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions and disease-free survival	Adverse reactions during the treatment and disease-free survival	2 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence or death	Recurrence or death	5 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Albumin-Bound Paclitaxel
• Other Study ID Numbers: aesa