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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01647672

Enrollment

Registered

2012-07-23

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DRUGAbraxane

Abraxane for neoadjuvant chemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
therapeutic assessment	6 months	therapeutic assessment

Secondary

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

Other

Measure	Time frame	Description
Recurrence or death	5 years	Recurrence or death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026