NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

Last updated: September 12, 2024
Sponsor: Lund University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Neoplasms

Cancer

Treatment

epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab

epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab

Clinical Study ID

NCT04335669
NBG-19-01; SWEBCG 19-01
  • Ages 18-75
  • All Genders

Study 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. Pembrolizumab is allowed in both arms after approval for TNBC 2022.

Eligibility Criteria

Inclusion

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 neoadjuvantchemotherapy followed by definitive surgery is planned.

  4. Node positive disease (N1-3) or if clinically N0 Tumor size >20 mm. When decidingT-stage the following hierarchy applies,

  5. MRI

  6. Ultrasound

  7. Mammography

  8. Clinical examination

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

  10. ER < 1% cells positive by immunohistochemistry (IHC) or ER ≤ 10% cells positiveby IHC and basal-like subtype using gene expression analysis

  11. ER < 10% cells positive by IHC and PgR < 10% cells positive by IHC

  12. HER2-normal tumor defined according to applicable national guidelines

  13. Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breastcancer associated genes.

  14. WHO performance status 0 or 1.

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

  16. Willingness of female patients of childbearing potential, male patients, and theirsexual partners to use an effective means of contraception during the treatmentperiod and at least 6 months thereafter.

  17. Willingness by the patient to undergo treatment and study related proceduresaccording to the protocol.

Exclusion

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 ofthe 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: Inpatients 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 patienthas 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 alkalinephosphatase (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 therequirements of the protocol.

  9. Patients with known deficiency of the DPD-enzyme who completely lack DPD.

Study Design

Total Participants: 325
Treatment Group(s): 2
Primary Treatment: epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab
Phase: 3
Study Start date:
December 20, 2019
Estimated Completion Date:
June 30, 2035

Study 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 of a carboplatin-based treatment and treatment adding capecitabine on pCR. After the approval of pembrolizumab in the preoperative treatment of early TNBC in 2022 the study will consist of two cohorts, one (cohort 1) without the addition of pembrolizumab, and one (cohort 2) with the addition of pembrolizumab to both study arms. The primary evaluation will be performed on the entire study population including both cohorts.

Primary translational aim: To investigate if the effects of the treatments depend on homologous repair deficiency (HRD)-status. More specifically, the aim is to test for differential effect of the two treatments on pCR for HRD-negative (HRD low and intermediate by oncoscan) and HRD-positive (HRD high by oncoscan) patients.

Connect with a study center

  • Odense University Hospital

    Odense, Region Syd 5000
    Denmark

    Site Not Available

  • Vejle Hospital

    Vejle, Region Syd 7100
    Denmark

    Site Not Available

  • Aalborg Universitetshospita

    Aalborg, 9000
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Sydvestjysk Sygehus

    Esbjerg, 6700
    Denmark

    Active - Recruiting

  • Nordsjællands Hospital

    Hillerød, 3400
    Denmark

    Active - Recruiting

  • Regionsjælland Næstved Sygehus

    Næstved, 4700
    Denmark

    Active - Recruiting

  • Sønderborg sygehus

    Sønderborg, 6300
    Denmark

    Active - Recruiting

  • Vejle syghus

    Vejle, 7100
    Denmark

    Active - Recruiting

  • Centralsjukhuset i Kristianstad

    Kristianstad, Skåne 291 85
    Sweden

    Active - Recruiting

  • Södra Älvsborgs Hospital

    Borås, 501 82
    Sweden

    Active - Recruiting

  • Gävle hospital, Department of Oncology

    Gävle, 803 24
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital, Department of Oncology

    Göteborg, 413 46
    Sweden

    Active - Recruiting

  • Halmstad Hospital, Department of Surgery

    Halmstad, 302 33
    Sweden

    Site Not Available

  • Ryhov Hospital

    Jönköping, 551 85
    Sweden

    Active - Recruiting

  • Karlstad Hospital

    Karlstad, 652 30
    Sweden

    Active - Recruiting

  • Linköping University Hospital

    Linköping, 581 85
    Sweden

    Site Not Available

  • Skåne University Hospital, Department of Oncology

    Malmö, 20501
    Sweden

    Active - Recruiting

  • Capio S:t Göran Hospital, Department of Oncology

    Stockholm, 112 19
    Sweden

    Active - Recruiting

  • Södersjukhuset, Department of Oncology

    Stockholm, 118 61
    Sweden

    Active - Recruiting

  • Sundsvall hospital

    Sundsvall, 851 86
    Sweden

    Active - Recruiting

  • Norrland University Hospital, Department of Oncology

    Umeå, 907 37
    Sweden

    Active - Recruiting

  • Academical Hospital, Department of Oncology

    Uppsala, 753 09
    Sweden

    Active - Recruiting

  • Västmanlands Hopsital Västerås

    Västerås, 721 89
    Sweden

    Active - Recruiting

  • Växjö Hospital, Department of Oncology

    Växjö, 352 34
    Sweden

    Active - Recruiting

  • Örebro University Hospital, Department of Oncology

    Örebro, 701 85
    Sweden

    Active - Recruiting

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