NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

Launched by LUND UNIVERSITY HOSPITAL · Apr 2, 2020

Keywords

ClinConnect Summary

The NordicTrip clinical trial is studying a new approach to treat early-stage triple-negative breast cancer (TNBC) before surgery. Researchers want to find out if adding a drug called capecitabine to the usual chemotherapy (carboplatin) can improve the chances of patients achieving a complete response to treatment, meaning no signs of cancer are found after chemotherapy. This study is open to adults aged 18 to 75 who have a specific type of breast cancer that is both estrogen receptor-negative and HER2-negative. Participants will also have to consent to screening for certain genetic mutations linked to breast cancer.

If you join this trial, you can expect to receive either the standard chemotherapy or the standard chemotherapy plus capecitabine. All participants will be monitored closely and will need to follow specific guidelines, including using effective contraception if there's a chance of pregnancy. It's important to note that people with a history of certain other cancers, serious health issues, or currently breastfeeding may not be eligible. This trial is currently recruiting participants, and your involvement could contribute to important advancements in breast cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed written informed consent approved by the Ethical Review Board (IRB).
• • 2. Age ≥ 18 to \< 76 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. When deciding T-stage the following hierarchy applies,
• • 1. MRI
• • 2. Ultrasound
• • 3. Mammography
• • 4. Clinical examination
• 5. ER negative tumor defined by at least one the following:
• • 1. ER \< 1% cells positive by immunohistochemistry (IHC) or ER ≤ 10% cells positive by IHC and basal-like subtype using gene expression analysis
• • 2. ER \< 10% cells positive by IHC and PgR \< 10% cells positive by IHC
• • 6. HER2-normal tumor defined according to applicable national guidelines
• • 7. Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breast cancer associated genes.
• • 8. 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 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.
• • 11. Willingness by the patient to undergo treatment and study related procedures according to the protocol.
• 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 \< 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
• • 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.