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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jan 2012
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 25, 2012
July 1, 2012
11 months
July 18, 2012
July 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
therapeutic assessment
therapeutic assessment
6 months
Secondary Outcomes (1)
Adverse reactions and disease-free survival
2 year
Other Outcomes (1)
Recurrence or death
5 years
Study Arms (1)
Abraxane
EXPERIMENTALAbraxane for neoadjuvant chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jin Zhang, Professor
Tianjin Cancer Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 23, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
July 25, 2012
Record last verified: 2012-07