Status:
ACTIVE_NOT_RECRUITING
NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC
Lead Sponsor:
Lund University Hospital
Collaborating Sponsors:
Swedish Breast Cancer Group
Danish Breast Cancer Cooperative Group
Conditions:
Breast Cancer
Triple Negative Breast Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Primary aim: 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...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Previous chemotherapy for cancer or other malignant disease.
- Charlson comorbidity index, excluding score for malignancy: (CCI) \> 2, Comment: In patients 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 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
- 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 the requirements of the protocol.
- Patients with known deficiency of the DPD-enzyme who completely lack DPD.
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2035
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT04335669
Start Date
December 20 2019
End Date
September 1 2035
Last Update
September 12 2025
Active Locations (24)
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1
Vejle Hospital
Vejle, Region Syd, Denmark, 7100
2
Aalborg Universitetshospita
Aalborg, Denmark, 9000
3
Rigshospitalet
Copenhagen, Denmark, 2100
4
Sydvestjysk Sygehus
Esbjerg, Denmark, 6700