Clinical trial NCT01625429: Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Shanghai Cancer Hospital, China
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pathological complete response rate
timeFrame: Obtained within six months of the last patient's enrollment
Secondary outcomes:
measure: Overall response rate
timeFrame: Obtained within six months of the last patient's enrollment
measure: Three-year disease free survival
timeFrame: Obtained within 42 months after last patient's enrollment
measure: Overall survival
timeFrame: Obtained around 5 years after the last patient's erollment
measure: Safety
timeFrame: Obtained around six months after the last patient's enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Zhimin Shao, MD
role: PRINCIPAL_INVESTIGATOR
References: