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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2009 by Fudan University
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01170143
First received: July 21, 2010
Last updated: July 26, 2010
Last verified: June 2009
  Purpose

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)


Condition Intervention Phase
Breast Cancer
Drug: Trastuzumab QW, Trastuzumab Q3W
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fudan University:

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). [ Time Frame: 3 years from last patient randomized ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trastuzumab QW
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
two arms using Trastuzumab QW vs Q3W
Other Name: Herceptin
Active Comparator: Trastuzumab Q3W
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
two arms using Trastuzumab QW vs Q3W
Other Name: Herceptin

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170143

Contacts
Contact: Zhimin Shao, Post-doctor 86 21 64175590 ext 8888 zhimingshao@yahoo.com
Contact: Canmin Chen, Bachelor 86 21 64175590 ext 8603 cmchen@medmail.com.cn

Locations
China, Shanghai
Cancer Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhimin Shao, Post-Doctor    86 21 64175590 ext 8888    zhimingshao@yahoo.com   
Sponsors and Collaborators
Fudan University
Hoffmann-La Roche
Investigators
Principal Investigator: Zhimin Shao, Post-Doctor Cancer Hospital Affiliated to Fudan University
  More Information

No publications provided

Responsible Party: Zhimin Shao/professor, Cancer Hospital Affiliated to Fudan University
ClinicalTrials.gov Identifier: NCT01170143     History of Changes
Other Study ID Numbers: ML22700
Study First Received: July 21, 2010
Last Updated: July 26, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
IIB-IIIB Breast Cancer
Her2 positive

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Paclitaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014