Back to resultsEfficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer (PCH)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Trastuzumab QW, Trastuzumab Q3W
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring IIB-IIIB Breast Cancer, Her2 positive
Eligibility Criteria
Inclusion Criteria:
- Women aged equals to or more than 18 years and no more than 70 years with life expectancy more than 12 months
- Histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, T2N1 or local advanced breast cancer, with no evidence of metastasis
- HER2 positive confirmed by FISH/CISH+ or IHC 3+
- With no history of cancer other than in situ uterine cervix cancer or skin basal cell carcinoma
- Adequate hematopoietic function: Neutrophil larger than 1.5*109/L; Hb larger than 100g/L; PLT larger than 100*109/L
Adequate hepatic and renal function
- serum AST less than 60U/L
- Total bilirubin less than 1.5 ULN
- serum creatinine less than 110umol/L
- BUN less than 7.1mmol/L
- LVEF 55% by MUGA scan or echocardiography
- Adequate coagulation function
- ECOG PS 0-1
- Willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
- Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
- Signed written informed consent; Able to comply with the protocol
Exclusion Criteria:
- Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
- Metastatic breast cancer
- Patients with medical conditions that renders them intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, Diabetes Mellitus, severe infection, active peptic ulcer, Coagulation disorder, connective tissue disease or myelo-suppressive disease
- History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (Systolic BP more than 180mmHg or Diastolic BP more than 100mmHg）
- grade 1 peripheral neuropathy from any cause
- Patient is pregnant or nursing
- Not willing to take pre-operative biopsy or neo-adjuvant therapy
- Patients with psychiatric disorder or other disease leading to incompliance to the therapy
- Known hypersensitivity to any ingredient of the regimen
- Treatment with any investigational drug within 30 days before the beginning of treatment with study drug
Sites / Locations
- Cancer Hospital Affiliated to Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Trastuzumab QW
Trastuzumab Q3W
Arm Description
Arm A: Trastuzumab 2mg/kg, d1; qw (loading dose 4mg/kg wk1) Paclitaxel 80mg/m2,. d1; qw Carboplatin AUC 2 d1, qw
Arm B: Trastuzumab 6mg/kg, d1(loading dose 8mg/kg wk1) Paclitaxel 175mg/m2,. d1, q3w; Carboplatin AUC 6 ,. d1,q3w
Outcomes
Primary Outcome Measures
Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH).
Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH). The primary efficacy variable is the rate of pathological complete response (pCR). Time to recurrence will be measured as the time from when the patient was randomized to the time the patient is first recorded as having disease recurrence or the date of death if the patient dies due to causes other than disease recurrence.
Secondary Outcome Measures
Full Information
NCT ID
NCT01170143
First Posted
July 21, 2010
Last Updated
July 26, 2010
Sponsor
Fudan University
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT01170143
Brief Title
Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer
Acronym
PCH
Official Title
A Randomized Study to Investigate the Efficacy and Safety of qw or q3w Trastuzumab, Paclitaxel and Carboplatin in Patients With IIB-IIIB HER2 Positive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH)
Detailed Description
Currently Herceptin has moved to Neoadjuvant treatment combined with chemotherapy. Paclitaxel and Carboplatin are two of the best partners with high pCR. The significant efficacy and good safety profile of Herceptin® combination with taxane as adjuvant treatment on EBC are accepted; 1 year of Herceptin as adjuvant treatment is one standard therapy. This study is one small Phase II trial to explore the efficacy and safety of QW and Q3W of PCH as Neoadjuvant treatment, we only plan 60 pts and the trend of the two curves is anticipated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
IIB-IIIB Breast Cancer, Her2 positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trastuzumab QW
Arm Type
Active Comparator
Arm Description
Arm A: Trastuzumab 2mg/kg, d1; qw (loading dose 4mg/kg wk1) Paclitaxel 80mg/m2,. d1; qw Carboplatin AUC 2 d1, qw
Arm Title
Trastuzumab Q3W
Arm Type
Active Comparator
Arm Description
Arm B: Trastuzumab 6mg/kg, d1(loading dose 8mg/kg wk1) Paclitaxel 175mg/m2,. d1, q3w; Carboplatin AUC 6 ,. d1,q3w
Intervention Type
Drug
Intervention Name(s)
Trastuzumab QW, Trastuzumab Q3W
Other Intervention Name(s)
Herceptin
Intervention Description
two arms using Trastuzumab QW vs Q3W
Primary Outcome Measure Information:
Title
Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH).
Description
Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH). The primary efficacy variable is the rate of pathological complete response (pCR). Time to recurrence will be measured as the time from when the patient was randomized to the time the patient is first recorded as having disease recurrence or the date of death if the patient dies due to causes other than disease recurrence.
Time Frame
3 years from last patient randomized
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:
Women aged equals to or more than 18 years and no more than 70 years with life expectancy more than 12 months
Histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, T2N1 or local advanced breast cancer, with no evidence of metastasis
HER2 positive confirmed by FISH/CISH+ or IHC 3+
With no history of cancer other than in situ uterine cervix cancer or skin basal cell carcinoma
Adequate hematopoietic function: Neutrophil larger than 1.5*109/L; Hb larger than 100g/L; PLT larger than 100*109/L
Adequate hepatic and renal function
serum AST less than 60U/L
Total bilirubin less than 1.5 ULN
serum creatinine less than 110umol/L
BUN less than 7.1mmol/L
LVEF 55% by MUGA scan or echocardiography
Adequate coagulation function
ECOG PS 0-1
Willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
Signed written informed consent; Able to comply with the protocol
Exclusion Criteria:
Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
Metastatic breast cancer
Patients with medical conditions that renders them intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, Diabetes Mellitus, severe infection, active peptic ulcer, Coagulation disorder, connective tissue disease or myelo-suppressive disease
History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (Systolic BP more than 180mmHg or Diastolic BP more than 100mmHg）
grade 1 peripheral neuropathy from any cause
Patient is pregnant or nursing
Not willing to take pre-operative biopsy or neo-adjuvant therapy
Patients with psychiatric disorder or other disease leading to incompliance to the therapy
Known hypersensitivity to any ingredient of the regimen
Treatment with any investigational drug within 30 days before the beginning of treatment with study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhimin Shao, Post-doctor
Phone
86 21 64175590
Ext
8888
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Canmin Chen, Bachelor
Phone
86 21 64175590
Ext
8603
Email
cmchen@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, Post-Doctor
Organizational Affiliation
Cancer Hospital Affiliated to Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, Post-Doctor
Phone
86 21 64175590
Ext
8888
Email
zhimingshao@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer
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