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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01170143
• Other study ID #: ML22700
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2010
• Last updated: July 26, 2010
• Start date: August 2009
• Est. completion date: December 2015

Study information

• Verified date: June 2009
• Source: Fudan University
• Contact: Zhimin Shao, Post-doctor
• Phone: 86 21 64175590
• Email: zhimingshao[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab QW, Trastuzumab Q3W
two arms using Trastuzumab QW vs Q3W

Locations

Country	Name	City	State
China	Cancer Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes