Back to resultsNeoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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)
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neoadjuvant
Arm Description
Outcomes
Primary Outcome Measures
Pathological complete response rate
The percentage of patients with a pathological complete response after neoadjuvant therapy
Secondary Outcome Measures
Overall response rate
The percentage of patients with complete response or partial response after neoadjuvant therapy
Three-year disease free survival
The percentage of patients who survive without breast cancer recurrence or metastases three years after surgery
Overall survival
The overall survival time of all patients enrolled in the study presented by survival curve and median value
Safety
List and frequencies of adverse events occured during and one-month after the investigational drug treatment
Full Information
NCT ID
NCT01625429
First Posted
June 19, 2012
Last Updated
November 8, 2012
Sponsor
Shanghai Cancer Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT01625429
Brief Title
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Cancer Hospital, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
neoadjuvant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane, Herceptin
Intervention Description
nab-paclitaxel 125mg/m2, day 1, 8, 15, q4w; carboplatin AUC 2, day 1, 8, 15, q4w; for HER-2 positive patients: trastuzumab loading dose 4mg/kg, then 2mg/kg, day 1, 8, 15, 22, q4w. All patients will receive up to four cycles except for unacceptable toxicity
Primary Outcome Measure Information:
Title
Pathological complete response rate
Description
The percentage of patients with a pathological complete response after neoadjuvant therapy
Time Frame
Obtained within six months of the last patient's enrollment
Secondary Outcome Measure Information:
Title
Overall response rate
Description
The percentage of patients with complete response or partial response after neoadjuvant therapy
Time Frame
Obtained within six months of the last patient's enrollment
Title
Three-year disease free survival
Description
The percentage of patients who survive without breast cancer recurrence or metastases three years after surgery
Time Frame
Obtained within 42 months after last patient's enrollment
Title
Overall survival
Description
The overall survival time of all patients enrolled in the study presented by survival curve and median value
Time Frame
Obtained around 5 years after the last patient's erollment
Title
Safety
Description
List and frequencies of adverse events occured during and one-month after the investigational drug treatment
Time Frame
Obtained around six months after the last patient's enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer
We'll reach out to this number within 24 hrs