Clinical trial NCT01170143: Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: IIB-IIIB Breast Cancer
Her2 positive
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2010-07-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Women aged equals to or more than 18 years and no more than 70 years with life expectancy more than 12 months
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:

1. Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
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

Primary outcomes:
measure: 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).
timeFrame: 3 years from last patient randomized
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
affiliation: Cancer Hospital Affiliated to Fudan University
name: Zhimin Shao, Post-Doctor
role: PRINCIPAL_INVESTIGATOR
References: