Early triple negative breast cancer. MedDRA version: 20.0 Level: LLT Classification code 10006192 Term: Breast cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Epirubicin
Product Name: Epirubicin
Product Code: Not applicable.
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ---
CAS Number: ---
Current Sponsor code:
Sponsors
Skåne University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent approved by the Ethical Review Board (IRB). 2) Age = 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1) Clinical or radiological signs of metastatic disease. 2) History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer. 3) Previous chemotherapy for cancer or other malignant disease. 4) Charlson comorbidity index, excluding score for malignancy: (CCI) > 2, Comment: In patients 70-75 a CCI = 3 is allowed, see appendix B. 5) Inadequate organ function, suggested by the following laboratory results: a Absolute neutrophil count 2,5 x ULN f ASAT (SGOT) and/or ALAT (SGPT) > 1,5 x ULN with concurrent serum alkaline phosphatase (ALP) > 2,5 x ULN g Serum creatinine clearance < 50 ml/min 6) Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0) 7) Patient who is actively breast feeding. 8) Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 9) Patients with known deficiency of the DPD-enzyme who completely lack DPD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer.;Secondary Objective: •To compare invasive disease free (IDFS), breast cancer specific survival (BCSS), distant recurrence free survival (DRFS), and overall survival (OS). •To evaluate the tolerability defined by toxicity and dose intensity. Translational objectives: •To determine the pCR rates in different treatment arms stratified for Homologous Repair Deficiency (HRD) positive vs. HRD-negative/HRD- intermediate. •To characterize different subsets of TNBC in terms of morphology, epigenetic alterations as well as somatic and inherited genetic alterations. •To determine the pCR rate and long-term outcome in subsets of TNBC with defined molecular genetic alterations including BRCA1, BRCA2 and PALB2 germline mutations and others, BRCA1, BRCA2 and PALB2 somatic mutations and others and BRCA1 or RAD51 promoter metylation. ;Primary end point(s): pCR with the addition of capecitabine compared with carboplatin-based chemotherapy alone.;Timepoint(s) of evaluation of this end point: Post surgery, after completion of preoperative chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Invasive Disease Survival (IDFS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone. ? Breast Cancer Specific Survival (BCSS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone. ? Overall Survival (OS) with the addition of capecitabine compared with carboplatin-based chemotherapy alone. ;Timepoint(s) of evaluation of this end point: Annually during follow up period 1-10 years after treatment start. | — |
Countries
Denmark, Sweden
Contacts
Public ContactAccademical Trial Office.
Swedish Breast Cancer Group (SweBCG) .
Outcome results
None listed