Study Stopped
lack of enrollment
CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer
CETRA
Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive breast cancer.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedJuly 30, 2012
July 1, 2012
February 9, 2007
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete pathologic response rate
Secondary Outcomes (2)
toxicity of neoadjuvant treatment
predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment
Interventions
Eligibility Criteria
You may qualify if:
- Histological diagnosis of breast cancer
- Stage II-IIIB (T0-1-2-3-4-N+-M0 or T2-3-4-N0-M0; according to TNM AJCC classification, 2002)
- Hyperexpression of HER-2/neu (HercepTest 3+ or positive FISH test)
- Age\> 18 e \< 65 years
- Left ventricular ejection fraction (LVEF) \> or = 55%
- ECOG Performance Status 0-2
- Neutrophils \> or = 2000/mm³, platelets \> or = 100.000/mm³ , hemoglobin \> or = 10 g/dl), GOT, GPT and bilirubin \< 1.25 x the upper normal limit, creatinine \< 1.25 x the upper normal limit.
- Life expectancy \> 3 months
- Signed informed consent.
You may not qualify if:
- Any prior treatment for breast cancer
- Metastatic disease (M1)
- Performance status (ECOG) \> or = 3
- Current malignancy or history of prior malignancy within past 10 years (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix)
- Neutrophils \< 2.000/mm³ , platelets \< 100.000/mm³ , hemoglobin \< 10 g/dl.
- Creatinine \> 1.25 x the upper normal limit
- GOT and/or GPT and/or bilirubin \>1.25 x the upper normal limit.
- Concomitant conditions that, in the investigator's opinion, contraindicate the use of the drugs in the protocol.
- Congestive heart failure or history of congestive heart failure, unstable angina pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled arrhythmias
- Active infection
- Incapacity or refusal to provide informed consent.
- Inability to comply with follow up
- Pregnant or nursing females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, 80131, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea De Matteis, M.D.
NCI Naples, Division of Medical Oncology C
- PRINCIPAL INVESTIGATOR
Giuseppe D'Aiuto, M.D.
NCI Naples, Division of Surgical Oncology A
- PRINCIPAL INVESTIGATOR
Francesco Perrone, M.D., Ph.D.
NCI Naples, Clinical Trials Unit
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2007
First Posted
February 12, 2007
Study Start
September 1, 2007
Last Updated
July 30, 2012
Record last verified: 2012-07