Efficacy and Safety Study of Trastuzumab, Paclitaxel and Carboplatin on HER2+ Preoperative Breast Cancer
Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Trastuzumab QW, Trastuzumab Q3W (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Fudan University Official(s) and/or principal investigator(s): Zhimin Shao, Post-Doctor, Principal Investigator, Affiliation: Cancer Hospital Affiliated to Fudan University
Overall contact: Zhimin Shao, Post-doctor, Phone: 86 21 64175590, Ext: 8888, Email: zhimingshao@yahoo.com
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)
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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).
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Female.
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
Locations and Contacts
Zhimin Shao, Post-doctor, Phone: 86 21 64175590, Ext: 8888, Email: zhimingshao@yahoo.com
Cancer Hospital Affiliated to Fudan University, Shanghai, Shanghai 200032, China; Recruiting Zhimin Shao, Post-Doctor, Phone: 86 21 64175590, Ext: 8888, Email: zhimingshao@yahoo.com
Additional Information
Starting date: August 2009
Last updated: July 26, 2010
|