Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
NCT ID: NCT04224922
Last Updated: 2020-01-18
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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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2015-05-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single-arm
weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer
Paclitaxel
Carboplatinum
Epirubicin
Cyclophosphamide
Interventions
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Paclitaxel
Carboplatinum
Epirubicin
Cyclophosphamide
Eligibility Criteria
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Inclusion Criteria
* Baseline mammography, US. MR of the breast on clinical indication.
* FNA of suspicious axillary lymph node is indicated
* Pre-treatment SN biopsy is indicated in clinical N0
* Measurable loco-regional disease
* Adequate bone marrow function, defined as
* Absolute neutrophil count(ANC) \>1500\*109/L
* Platelet count \>100.000\*109/L
* Adequate liver function defined as
* Serum(total) bilirubin \<1.5\*upper limit of normal(ULN), unless the patient has documented Gilbert's Syndrome
* AST and/or ALT \<2.5\*ULN
* Alkaline phosphatase \<2.5\*ULN
* Normal cardiac function measured by ultrasound with a left ventricular function \> 55%
* Creatinine clearance \> 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function)
Exclusion Criteria
* Bilateral breast cancer
* Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix.
* Pregnant or lactating patients
18 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Universitair Ziekenhuis Brussel
OTHER
AZ-VUB
OTHER
Responsible Party
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Dr Fontaine Christel
Principle Investigator
Principal Investigators
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Christel Fontaine, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Cliniques Sud Luxembourg
Arlon, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
AZ klina
Brasschaat, , Belgium
St Lucas
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitaire Ziekenhuis Antwerpen
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
AZ St Lucas
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
CHR Citadelle
Liège, , Belgium
CHU Sart-Tilman
Liège, , Belgium
CMSE
Namur, , Belgium
Clinique st Pierre
Ottignies, , Belgium
CHWAPI
Tournai, , Belgium
CHR Verviers
Verviers, , Belgium
CHU Mont-Godinne
Yvoir, , Belgium
Countries
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Other Identifiers
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BSMO-2014-01
Identifier Type: -
Identifier Source: org_study_id
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