Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer
NCT ID: NCT01170143
Last Updated: 2010-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2009-08-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab QW
Arm A: Trastuzumab 2mg/kg, d1; qw (loading dose 4mg/kg wk1) Paclitaxel 80mg/m2,. d1; qw Carboplatin AUC 2 d1, qw
Trastuzumab QW, Trastuzumab Q3W
two arms using Trastuzumab QW vs Q3W
Trastuzumab Q3W
Arm B: Trastuzumab 6mg/kg, d1(loading dose 8mg/kg wk1) Paclitaxel 175mg/m2,. d1, q3w; Carboplatin AUC 6 ,. d1,q3w
Trastuzumab QW, Trastuzumab Q3W
two arms using Trastuzumab QW vs Q3W
Interventions
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Trastuzumab QW, Trastuzumab Q3W
two arms using Trastuzumab QW vs Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, T2N1 or local advanced breast cancer, with no evidence of metastasis
3. HER2 positive confirmed by FISH/CISH+ or IHC 3+
4. With no history of cancer other than in situ uterine cervix cancer or skin basal cell carcinoma
5. Adequate hematopoietic function: Neutrophil larger than 1.5\*109/L; Hb larger than 100g/L; PLT larger than 100\*109/L
6. 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
7. LVEF 55% by MUGA scan or echocardiography
8. Adequate coagulation function
9. ECOG PS 0-1
10. Willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
11. 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
12. Signed written informed consent; Able to comply with the protocol
Exclusion Criteria
2. Metastatic breast cancer
3. 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
4. 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）
5. grade 1 peripheral neuropathy from any cause
6. Patient is pregnant or nursing
7. Not willing to take pre-operative biopsy or neo-adjuvant therapy
8. Patients with psychiatric disorder or other disease leading to incompliance to the therapy
9. Known hypersensitivity to any ingredient of the regimen
10. Treatment with any investigational drug within 30 days before the beginning of treatment with study drug
18 Years
70 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Fudan University
OTHER
Responsible Party
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Cancer Hospital Affiliated to Fudan University
Principal Investigators
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Zhimin Shao, Post-Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital Affiliated to Fudan University
Locations
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Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML22700
Identifier Type: -
Identifier Source: org_study_id
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