NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

• Status: Recruiting
• Trial end date: 2032-12-25
• Target enrollment: 0
• Participant gender: All

Summary

Primary aim: Pathological complete response rate after preoperative chemotherapy is the primary end-point of the study, which will be evaluated by comparing the effects of neoadjuvant administration of a carboplatin-based treatment and treatment adding capecitabine on Pathological Complete Response (pCR).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Collaborators: Danish Breast Cancer Cooperative Group; Finnish Breast Cancer Group; Icelandic Breast Cancer Group; Swedish Breast Cancer Group
• Treatments: Albumin-Bound Paclitaxel; Antimetabolites; Capecitabine; Carboplatin; Cyclophosphamide; Epirubicin; Paclitaxel; Taxane

Criteria

Inclusion Criteria:

1. Signed written informed consent approved by the Ethical Review Board (IRB).

2. Age 18 to 75 years.

3. Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.

4. Node positive disease (N1-3) or if clinically N0 Tumor size >20 mm.

5. ER negative tumor defined by at least one the following:

1. ER < 1% cells positive by immuno-histochemistry (IHC)

2. ER < 10% cells positive by IHC and progesterone receptor) progesterone receptor (PgR) < 10% cells positive by IHC

6. Human Epidermal Growth Factor Receptor2 (HER2)-normal tumor defined by at least one of the following:

1. HER2 0 or 1+ by immunohistochemistry

2. HER2 2+ by IHC and HER2 to centromere 17 ratio < 2.0 and/or less than 6 copies by in situ hybridization [ISH]).

Comment: Patients with 3+ IHC for HER2 will not be included irrespective of the outcome of in situ hybridization (ISH)-analysis.

7. Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breast cancer associated genes.

8. World Health Organization (WHO) performance status 0 or 1.

9. Negative pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization).

10. Willingness by the patient to undergo treatment according to the protocol and study related procedures.

Exclusion Criteria:

1. Clinical or radiological signs of metastatic disease.

2. Clinically inflammatory breast cancer

3. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.

4. Previous chemotherapy for cancer or other malignant disease.

5. Charlson comorbidity index, excluding score for malignancy: (CCI) > 2, Comment: In patients 70-75 a CCI = 3 is allowed, see appendix B.

6. 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 Haemoglobin < 90 g/L d Total bilirubin greater than the upper limit of normal (ULN) unless the patient has documented Gilbert´s syndrome e Aspartate Aminotransferase (AST), (SGOT) and/or Alanine Aminotransferase (ALT), (SGPT) > 2,5 x ULN f AST (SGOT) and/or ALT (SGPT) > 1,5 x ULN with concurrent serum alkaline phosphatase (ALP) > 2,5 x ULN g Serum creatinine clearance < 50 mL/min

7. Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0)

8. Patient who is actively breast feeding.

9. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.