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A Single-center, Prospective, Phase II Study of Albumin-bound Paclitaxel (Nab-paclitaxel) and Carboplatin With or Without Trastuzumab (Herceptin) as Neoadjuvant Therapy in Locally Advanced Breast Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Single-center, Prospective, Phase II Study of Albumin-bound Paclitaxel (Nab-paclitaxel) and Carboplatin With or Without Trastuzumab (Herceptin) as Neoadjuvant Therapy in Locally Advanced Breast Cancer


Inclusion Criteria:



- Female, between 18 and 70 years old

- Life expectancy is more than 12 months

- Breast MRI or ultrasound confirmd tumor over 3cm and biopsy comfirned invasive breast
caner of stage II-III (inflammatory breast cancer excluded)

- Not accompanied with other malignancies(except for controlled carcinoma in situ of
the cervix or skin basal-cell carcinoma)

- A normal bone marrow: absolute neutrophil count≥1.5*10E9/L, hemoglobin≥100g/L,
PLT≥100*10E9/L

- Normal liver and renal functions: AST≤60U/L, total biliruin≤1.5*upper limit of
normal, serum creatinine≤110umol/L, urea nitrogen≤7.1mmol/L

- Normal blood coagulation function

- ECOG performance status of 0-1

- Willing to coordinate with a punch biopsy before treatment and accept neoadjuvant
therapy

- Women of child-producing potential must agree to use effective contraceptive methods
during the study, and a negative serum or urine pregnancy test must be obtained
within 7 days prior to administration of the drugs

- Written informed consent

- For HER-2 positive patients, the HER-2 status must be determined by ICH +++ or
FISH/CISH. For patients treated with trastuzumb, LVEF≥55% by ultrasonic cardiogram or
MUGA scan

Exclusion Criteria:

- Previous systematic or local therapy including chemotherapy for breast cancer

- Distant metastases of breast cancer are observed

- Concurrent uncontrolled lung disease, severe sepsis, active peptic ulcer requring
treatment, blood coagulation disorders, serious uncontrolled diabetes, connective
tissue disease or bone marrow depression, unable to tolerate neoadjuvant therapy and
related treatment

- >Grade 1 peripheral neuropathy caused by any reason

- History of CHF, uncontrolled symptomatic angina, history of arrhythmias or myocardial
infarction, poorly controlled hypertension (systolic pressure > 180mmHg or diastlic
pressure > 100 mmHg)

- Lactational or gestational breast cancer

- Not willing to accept a punch biopsy before treatment and neoadjuvant therapy

- Psychopath or any other reasons that would preclude compliane with treatment

- Known serious allergy to any of the study drugs or excipients

- Participation in another study requiring administration of an in investigational drug
or biological agent at present or recently (within the last 30 days prior to
screening visit)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathological complete response rate

Outcome Description:

The percentage of patients with a pathological complete response after neoadjuvant therapy

Outcome Time Frame:

Obtained within six months of the last patient's enrollment

Safety Issue:

No

Principal Investigator

Zhimin Shao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ministry of Health

Study ID:

ABX-1201

NCT ID:

NCT01625429

Start Date:

June 2012

Completion Date:

June 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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