NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

Prior treatment

• Previous chemotherapy for cancer or other malignant disease.
• Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0).

Other illness

• Clinical or radiological signs of metastatic disease.
• History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.
• Charlson comorbidity index, excluding score for malignancy: (CCI) \> 2, Comment: In patients 70-75 a CCI = 3 is allowed, see appendix B.

Lab values

• 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 patient has 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 alkaline phosphatase (ALP) \> 2,5 x ULN
  • g Serum creatinine clearance \< 50 ml/min

Other

• Patient who is actively breast feeding.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Patients with known deficiency of the DPD-enzyme who completely lack DPD.

• Signed written informed consent approved by the Ethical Review Board (IRB).
• Age ≥ 18 to \< 76 years.
• Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.
• Node positive disease (N1-3) or if clinically N0 Tumor size \>20 mm. When deciding T-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 positive by 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 breast cancer associated genes.
• WHO performance status 0 or 1.
• Negative pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization).
• Willingness of female patients of childbearing potential, male patients, and their sexual partners to use an effective means of contraception during the treatment period and at least 6 months thereafter.
• Willingness by the patient to undergo treatment and study related procedures according to the protocol.