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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Abraxane

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Karnofsky ≥ 70
Provision of informed consent
Pathological confirmation of breast cancer
Tumor stage (TNM):T2-4bN0-3M0
Measurable disease as per RECIST criteria
Not previously treated with radiotherapy, chemotherapy or biological therapy.
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:

Pregnant woman
History of organ transplantation
With mental disease
With severe infection or active gastrointestinal ulcers
With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ)
With heart disease
Experimental drug allergy

Sites / Locations

Tianjin Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abraxane

Arm Description

Abraxane for neoadjuvant chemotherapy

Outcomes

Primary Outcome Measures

therapeutic assessment

Secondary Outcome Measures

Adverse reactions and disease-free survival

Adverse reactions during the treatment and disease-free survival

Full Information

NCT ID

NCT01647672

First Posted

July 18, 2012

Last Updated

July 24, 2012

Sponsor

Tianjin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01647672

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Abraxane

Arm Type

Experimental

Arm Description

Abraxane for neoadjuvant chemotherapy

Intervention Type

Drug

Intervention Name(s)

Abraxane

Intervention Description

Abraxane for neoadjuvant chemotherapy

Primary Outcome Measure Information:

Title

therapeutic assessment

Description

therapeutic assessment

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Adverse reactions and disease-free survival

Description

Adverse reactions during the treatment and disease-free survival

Time Frame

2 year

Other Pre-specified Outcome Measures:

Title

Recurrence or death

Description

Recurrence or death

Time Frame

5 years

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Karnofsky ≥ 70 Provision of informed consent Pathological confirmation of breast cancer Tumor stage (TNM):T2-4bN0-3M0 Measurable disease as per RECIST criteria Not previously treated with radiotherapy, chemotherapy or biological therapy. 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: Pregnant woman History of organ transplantation With mental disease With severe infection or active gastrointestinal ulcers With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ) With heart disease Experimental drug allergy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Zhang, Professor

Organizational Affiliation

Tianjin Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Tianjin Cancer Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ZHANG SHENG, DOCTOR

Phone

86-022-23340123

Ext

2901

First Name & Middle Initial & Last Name & Degree

ZHANG SHENG, DORTOR

Phone

86-022-23340123

Ext

2901

First Name & Middle Initial & Last Name & Degree

ZHANG JIN, PROFESSOR

12. IPD Sharing Statement

Learn more about this trial

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

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