- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01340430
Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer
May 17, 2022 updated by: Lucia Del Mastro,MD
Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.
The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ge
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Genoa, Ge, Italy, 16132
- Istituto Nazionale per La Ricerca sul Cancro (IST)
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PG
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Perugia, PG, Italy, 06156
- Ospedale S. Maria della Misericordia - Oncologia Medica
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TO
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Candiolo, TO, Italy, 10060
- Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
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Torino, TO, Italy, 10128
- Ospedale Mauriziano Umberto I - Ginecologia Oncologica
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To
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Torino, To, Italy, 10100
- Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica
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VR
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Negrar, VR, Italy, 37024
- Ospedale Sacro Cuore - Don Calabria - Oncologia Medica
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer,
- Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
- Any N,
- No evidence of metastasis (M0);
- Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:
- 3+ over expression by immunohistochemistry (IHC) (> 30% of invasive tumour cells),
- 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,
- Her 2 gene amplication by FISH/CISH (ratio > 2.2);
- Known hormone receptor status
Hematopoietic status:
- absolute neutrophil count ≥ 1.5 x 109/L,
- platelet count ≥ 100 x 109/L,
Hepatic status:
- serum total bilirubin ≤ 1.5 x ULN. In the case of known Gilbert's syndrome a higher serum total bilirubin (< 2 x ULN) is allowed,
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,
- alkaline phosphatase ≤ 2.5 times ULN;
Renal status:
a. Creatinine ≤ 2.0 mg/dL;
Cardiovascular:
a. baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA);
- For women of childbearing potential negative serum pregnancy test
- Written informed consent.
Exclusion Criteria:
- Male gender
- Pregnant or lactating women
- Received any prior treatment for primary invasive breast cancer
- Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
- Active or uncontrolled infection,
- Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
- Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
- Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FEC-paclitaxel-trastuzumab
fluorouracil 600 mg/m2; epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2 for 4 cycles followed by paclitaxel 80 mg/m2/week in combination with trastuzumab for 12 weeks
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neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pathologic complete response
Time Frame: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
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at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: one year
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one year
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safety and tolerability
Time Frame: one year
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safety and tolerability will be assessed by standard clinical and laboratory tests (hematology, serum chemistry).
Toxicity grade is defined by the NCI Common Toxicity Criteria (CTC) Adverse Event (AE) v 3.0
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one year
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cardiotoxicity
Time Frame: one year
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one year
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disease free survival
Time Frame: one year
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one year
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rate of conversion from radical to conservative surgery
Time Frame: definitive surgery
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definitive surgery
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potential biomarkers of trastuzumab resistance
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lucia Del Mastro, MD, National Institute For Cancer Reasearch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2015
Study Completion (Anticipated)
May 1, 2025
Study Registration Dates
First Submitted
April 6, 2011
First Submitted That Met QC Criteria
April 21, 2011
First Posted (Estimate)
April 22, 2011
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEOHER-021
- 2010-021600-24 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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