Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer

NCT01170143 | Unknown Phase 2 DMC

• 1 other identifier: ML22700
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Breast Cancer

Keywords

IIB-IIIB Breast Cancer; Her2 positive

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years from last patient randomized

Study Arms (2)

Trastuzumab QW

ACTIVE COMPARATOR

Arm A: Trastuzumab 2mg/kg, d1; qw (loading dose 4mg/kg wk1) Paclitaxel 80mg/m2,. d1; qw Carboplatin AUC 2 d1, qw

Drug: Trastuzumab QW, Trastuzumab Q3W

Trastuzumab Q3W

ACTIVE COMPARATOR

Arm B: Trastuzumab 6mg/kg, d1(loading dose 8mg/kg wk1) Paclitaxel 175mg/m2,. d1, q3w; Carboplatin AUC 6 ,. d1,q3w

Drug: Trastuzumab QW, Trastuzumab Q3W

Interventions

Trastuzumab QW, Trastuzumab Q3W DRUG

two arms using Trastuzumab QW vs Q3W

Also known as: Herceptin

Trastuzumab Q3W; Trastuzumab QW

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Cancer Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhimin Shao, Post-Doctor

  Cancer Hospital Affiliated to Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, Post-doctor

CONTACT

86 21 64175590; zhimingshao@yahoo.com

Canmin Chen, Bachelor

CONTACT

86 21 64175590; cmchen@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 27, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 27, 2010

Record last verified: 2009-06

Locations

CN (1)