Phase
Condition
Breast Cancer
Neoplasms
Cancer
Treatment
epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab
epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed written informed consent approved by the Ethical Review Board (IRB).
Age ≥ 18 to < 76 years.
Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvantchemotherapy followed by definitive surgery is planned.
Node positive disease (N1-3) or if clinically N0 Tumor size >20 mm. When decidingT-stage the following hierarchy applies,
MRI
Ultrasound
Mammography
Clinical examination
ER negative tumor defined by at least one the following:
ER < 1% cells positive by immunohistochemistry (IHC) or ER ≤ 10% cells positiveby IHC and basal-like subtype using gene expression analysis
ER < 10% cells positive by IHC and PgR < 10% cells positive by IHC
HER2-normal tumor defined according to applicable national guidelines
Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breastcancer associated genes.
WHO performance status 0 or 1.
Negative pregnancy test in women of childbearing potential (premenopausal or <12months of amenorrhea post-menopause and who have not undergone surgicalsterilization).
Willingness of female patients of childbearing potential, male patients, and theirsexual partners to use an effective means of contraception during the treatmentperiod and at least 6 months thereafter.
Willingness by the patient to undergo treatment and study related proceduresaccording to the protocol.
Exclusion
Exclusion Criteria:
Clinical or radiological signs of metastatic disease.
History of other malignancy within the last 5 years, except for carcinoma in situ ofthe cervix or non-melanoma skin cancer.
Previous chemotherapy for cancer or other malignant disease.
Charlson comorbidity index, excluding score for malignancy: (CCI) > 2, Comment: Inpatients 70-75 a CCI = 3 is allowed, see appendix B.
Inadequate organ function, suggested by the following laboratory results: a Absolute neutrophil count < 1,5 x 109/L b Platelet count < 100 x 109/L c Hemoglobin < 90 g/L d Total bilirubin greater than the upper limit of normal (ULN) unless the patienthas documented Gilbert´s syndrome e ASAT (SGOT) and/or ALAT (SGPT) > 2,5 x ULN f ASAT (SGOT) and/or ALAT (SGPT) > 1,5 x ULN with concurrent serum alkalinephosphatase (ALP) > 2,5 x ULN g Serum creatinine clearance < 50 ml/min
Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0).
Patient who is actively breast feeding.
Assessed by the Investigator to be unable or unwilling to comply with therequirements of the protocol.
Patients with known deficiency of the DPD-enzyme who completely lack DPD.
Study Design
Study Description
Connect with a study center
Odense University Hospital
Odense, Region Syd 5000
DenmarkSite Not Available
Vejle Hospital
Vejle, Region Syd 7100
DenmarkSite Not Available
Aalborg Universitetshospita
Aalborg, 9000
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen, 2100
DenmarkActive - Recruiting
Sydvestjysk Sygehus
Esbjerg, 6700
DenmarkActive - Recruiting
Nordsjællands Hospital
Hillerød, 3400
DenmarkActive - Recruiting
Regionsjælland Næstved Sygehus
Næstved, 4700
DenmarkActive - Recruiting
Sønderborg sygehus
Sønderborg, 6300
DenmarkActive - Recruiting
Vejle syghus
Vejle, 7100
DenmarkActive - Recruiting
Centralsjukhuset i Kristianstad
Kristianstad, Skåne 291 85
SwedenActive - Recruiting
Södra Älvsborgs Hospital
Borås, 501 82
SwedenActive - Recruiting
Gävle hospital, Department of Oncology
Gävle, 803 24
SwedenActive - Recruiting
Sahlgrenska University Hospital, Department of Oncology
Göteborg, 413 46
SwedenActive - Recruiting
Halmstad Hospital, Department of Surgery
Halmstad, 302 33
SwedenSite Not Available
Ryhov Hospital
Jönköping, 551 85
SwedenActive - Recruiting
Karlstad Hospital
Karlstad, 652 30
SwedenActive - Recruiting
Linköping University Hospital
Linköping, 581 85
SwedenSite Not Available
Skåne University Hospital, Department of Oncology
Malmö, 20501
SwedenActive - Recruiting
Capio S:t Göran Hospital, Department of Oncology
Stockholm, 112 19
SwedenActive - Recruiting
Södersjukhuset, Department of Oncology
Stockholm, 118 61
SwedenActive - Recruiting
Sundsvall hospital
Sundsvall, 851 86
SwedenActive - Recruiting
Norrland University Hospital, Department of Oncology
Umeå, 907 37
SwedenActive - Recruiting
Academical Hospital, Department of Oncology
Uppsala, 753 09
SwedenActive - Recruiting
Västmanlands Hopsital Västerås
Västerås, 721 89
SwedenActive - Recruiting
Växjö Hospital, Department of Oncology
Växjö, 352 34
SwedenActive - Recruiting
Örebro University Hospital, Department of Oncology
Örebro, 701 85
SwedenActive - Recruiting
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