Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast Cancer
NCT ID: NCT01428414
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2011-08-31
2015-02-28
Brief Summary
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Detailed Description
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In the investigators study, Trastuzumab was concomitantly administered with different chemotherapies after randomization to determine the effect of this approach on the pathologic CR rates. 100 patients from multicenter would be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed by operation and adjuvant treatment. Pathological complete response rate (pCR), disease free survival (DFS), response rates (RR), percentage of conserving breast surgery and adverse events including Serious AEs and non-serious AEs would be compared. The follow up time for each patients would be 3 years at most.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab+ Carboplatin+Paclitaxel
Neoadjuvant treatment regimen:Trastuzumab,Carboplatin,Paclitaxel
Trastuzumab
2 mg/kg, iv, d1,8,15(loading dose 4mg/kg wk1), qw
Paclitaxel
75mg/m2, iv d1, 8,15. qw; 4-6 cycles
Carboplatin
AUC 2, qw, iv d1, 8,15. 4-6 cycles
Trastuzumab+Epirubicin+Paclitaxel
Neoadjuvant treatment regimen:Trastuzumab,Epirubicin,Paclitaxel
Trastuzumab
2 mg/kg, iv, d1,8,15(loading dose 4mg/kg wk1), qw
Paclitaxel
75mg/m2, iv d1, 8,15. qw; 4-6 cycles
Epirubicin
75mg/m2, iv d1, q3w, 4-6 cycles
Interventions
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Trastuzumab
2 mg/kg, iv, d1,8,15(loading dose 4mg/kg wk1), qw
Paclitaxel
75mg/m2, iv d1, 8,15. qw; 4-6 cycles
Epirubicin
75mg/m2, iv d1, q3w, 4-6 cycles
Carboplatin
AUC 2, qw, iv d1, 8,15. 4-6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years and \< 70 years with life expectancy \> 12 months
3. Histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, staged II-III according to TNM Classification System, with no evidence of metastasis and tumor size ≥3 cm
4. HER2 positive confirmed by IHC 2+ and FISH positivity or IHC 3+
5. At least one measurable lesion according to RECIST criteria 1.1
6. Patients with a left ventricular ejection fraction(LVEF)≥55% by MUGA scan or echocardiography
7. ECOG PS 0-1
8. Willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
9. Signed written informed consent; Able to comply with the protocol
Exclusion Criteria
2. 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
3. Previous treatment with chemotherapy or hormonal therapy or any prior therapy with an anti-HER2 therapy for any malignancy.
4. History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction
5. Other invasive malignancy (including second primary breast cancer) which could affect compliance with the protocol or interpretation of results. Patients who have been curatively treated and free of malignant disease for greater than 5 years are generally eligible
6. Inadequate bone marrow, hepatic and renal functions as evidenced by the following:
* Neutrophil count of \<1500/uL,
* Platelet count of \<100,000/uL.
* Haemoglobin \<10 g/dL.
* Serum total bilirubin \> 1.5\*ULN (upper limit of normal),
* ALT or AST \> 2.5\*ULN,
* Alkaline phosphatase \> 2.5\*ULN,
* Serum creatinine \> 1.5\*ULN.
7. Other serious illness or medical condition including:
* Congestive heart failure (NYHA class II, III, IV) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias.
* Patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy.
* Active serious uncontrolled infections.
* Poorly controlled diabetes mellitus.
8. Not willing to take pre-operative biopsy or neo-adjuvant therapy
9. Patients with psychiatric disorder or other disease leading to incompliance to the therapy
10. Known hypersensitivity to any ingredient of the regimen
11. Treatment with any investigational drug within 30 days before the beginning of treatment with study drug.
18 Years
69 Years
FEMALE
No
Sponsors
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Roche Pharma AG
INDUSTRY
Zhimin Shao
OTHER
Responsible Party
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Zhimin Shao
Professor and director of department of the Breast Cancer Institute, Fudan University
Principal Investigators
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Zhi-Ming Shao, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Sikov WM, Dizon DS, Strenger R, Legare RD, Theall KP, Graves TA, Gass JS, Kennedy TA, Fenton MA. Frequent pathologic complete responses in aggressive stages II to III breast cancers with every-4-week carboplatin and weekly paclitaxel with or without trastuzumab: a Brown University Oncology Group Study. J Clin Oncol. 2009 Oct 1;27(28):4693-700. doi: 10.1200/JCO.2008.21.4163. Epub 2009 Aug 31.
Chang HR. Trastuzumab-based neoadjuvant therapy in patients with HER2-positive breast cancer. Cancer. 2010 Jun 15;116(12):2856-67. doi: 10.1002/cncr.25120.
Piccart-Gebhart MJ, Burzykowski T, Buyse M, Sledge G, Carmichael J, Luck HJ, Mackey JR, Nabholtz JM, Paridaens R, Biganzoli L, Jassem J, Bontenbal M, Bonneterre J, Chan S, Basaran GA, Therasse P. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol. 2008 Apr 20;26(12):1980-6. doi: 10.1200/JCO.2007.10.8399.
Nistico C, Bria E, Cuppone F, Fornier M, Sperduti I, Carpino A, Pace A, Cognetti F, Terzoli E. Weekly epirubicin and paclitaxel with granulocyte colony-stimulating factor support in previously untreated metastatic breast cancer patients: a phase II study. Anticancer Drugs. 2007 Jul;18(6):687-92. doi: 10.1097/CAD.0b013e328035f863.
Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010 Jan 30;375(9712):377-84. doi: 10.1016/S0140-6736(09)61964-4.
Han S, Kim J, Lee J, Chang E, Gwak G, Cho H, Yang KH, Park S, Park K. Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer. Eur J Surg Oncol. 2009 Jun;35(6):583-7. doi: 10.1016/j.ejso.2009.01.002. Epub 2009 Feb 5.
Other Identifiers
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ML27770
Identifier Type: -
Identifier Source: org_study_id