Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer

Shanghai Cancer Hospital, China

Status and phase

Unknown

Phase 2

Conditions

Breast Cancer

Treatments

Drug: nab-paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT01625429

ABX-1201

Details and patient eligibility

About

This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)