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Breast CancerPhase 3NCT04335669

NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

A Phase 3 study testing epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab and epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab in people with Breast Cancer and Triple Negative Breast Neoplasms, run by Lund University Hospital at 24 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab and epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
24 sitesin 2 countries
Study dates
20 Dec 2019to Sep 2035
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

Sweden16 sites

  • Södra Älvsborgs Hospital

    Borås, 501 82

  • Gävle hospital, Department of Oncology

    Gävle, 803 24

  • Sahlgrenska University Hospital, Department of Oncology

    Gothenburg, 413 46

  • Halmstad Hospital, Department of Surgery

    Halmstad, 302 33

  • Ryhov Hospital

    Jönköping, 551 85

  • Karlstad Hospital

    Karlstad, 652 30

  • Centralsjukhuset i Kristianstad

    Kristianstad, Skåne County, 291 85

  • Skåne University Hospital, Department of Oncology

    Malmö, 20501

  • Örebro University Hospital, Department of Oncology

    Örebro, 701 85

  • Capio S:t Göran Hospital, Department of Oncology

    Stockholm, 112 19

  • Södersjukhuset, Department of Oncology

    Stockholm, 118 61

  • Sundsvall hospital

    Sundsvall, 851 86

  • Norrland University Hospital, Department of Oncology

    Umeå, 907 37

  • Academical Hospital, Department of Oncology

    Uppsala, 753 09

  • Västmanlands Hopsital Västerås

    Västerås, 721 89

  • Växjö Hospital, Department of Oncology

    Vaxjo, 352 34

Other trials in Sweden

Denmark8 sites

  • Aalborg Universitetshospita

    Aalborg, 9000

  • Rigshospitalet

    Copenhagen, 2100

  • Sydvestjysk Sygehus

    Esbjerg, 6700

  • Nordsjællands Hospital

    Hillerød, 3400

  • Regionsjælland Næstved Sygehus

    Næstved, 4700

  • Sønderborg sygehus

    Sønderborg, 6300

  • Vejle Hospital

    Vejle, Region Syd, 7100

  • Vejle syghus

    Vejle, 7100

Other trials in Denmark

About this study

Official title: A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early "Triple Negative" Breast Cancer

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.

Read the 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 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.

Being tested
epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab, epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab
Keywords
Breast neoplasms, Triple negative breast neoplasms, Neoadjuvant treatment, Translational research, Pathologic response, Pathologic complete response, epirubicin, cyclophosphamide, paclitaxel, carboplatin, capecitabine, Survival outcomes, Homologous repair deficiency, pembrolizumab
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms, Pathologic Complete Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumabDrug

    Also called anthracycline, taxane, platinum

    Cytotoxic agents.

  • epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumabDrug

    Also called anthracycline, taxane, antimetabolite, platinum

    Cytotoxic agents.

Study groups in NCT04335669
Study groupRoleWhat they receive
Arm A (Platinum-based dose dense EC):Active comparatorddEC x 4 + pembrolizumab→ PK x 4 + pembrolizumab, Two-weekly epirubicin/cyclophosphamide (EC) x 4 (epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2), followed after a three-week interval by three-weekly carboplatin x 4 (AUC = 5) together with weekly paclitaxel x 12 (80 mg/m2). Pembrolizumab is given as a 400 mg iv dosis every 6 weeks for the duration of preoperative chemotherapy.*
Receives: Drug: epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab
Arm B (Platinum-based with capecitabine):ExperimentalCEX x 4→ PK x 4, Three-weekly cyclophosphamide/epirubicin/capecitabine (CEX) (epirubicin 75 mg/m2, cyclophosphamide 600 mg/m2 and capecitabine 900 mg/m2) x 4, followed after a three-week interval by three-weekly carboplatin x 4 (AUC = 5) together with weekly paclitaxel x 12 (80 mg/m2).Pembrolizumab is given as a 400 mg iv dosis every 6 weeks for the duration of preoperative chemotherapy.* *The addition of pembrolizumab is strongly recommended to all participating patients. However, patients with a documented contraindication, or unwilling to receive immunotherapy may be included in the study without the administration of pembrolizumab.
Receives: Drug: epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate.

    Rate of pathological complete response, allowing residual dcis, at surgery after preoperative chemotherapy.

    Measured: Immediately after surgery

  2. Primary translational outcome.

    Pathological complete response rate, allowing residual dcis, stratified for homologous repair deficiency.

    Measured: Immediately after surgery

Secondary outcomes (6)

  1. Invasive Disease Free Survival (IDFS)

    Invasive disease-free survival

    Measured: Throughout the study, an average of 3 years

  2. Overall Survival (OS)

    Overall survival

    Measured: Throughout the study, an average of 5 years

  3. Breast Cancer Specific Survival (BCSS)

    Breast cancer specific survival

    Measured: Throughout the study, an average of 3 years

  4. Distant Recurrence Free Survival (DRFS)

    Distant recurrence free survival.

    Measured: Throughout the study, an average of 3 years

  5. Dose intensity

    Actual dosis/dosis per protocol

    Measured: Immediately after surgery

  6. Toxicity according to CTCAE version 5.0

    Rate of included patients with toxicity grade 3 or greater during study treatment

    Measured: Immediately after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start20 Dec 2019
  3. Primary completionSep 2035 (estimated)
  4. Study completionSep 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
325 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335669
Sponsor's protocol ID
NBG-19-01; SWEBCG 19-01
Status last verified
Sep 2025
First submitted
2 Dec 2019
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab and epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab in people with Breast Cancer and Triple Negative Breast Neoplasms, run by Lund University Hospital at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Sweden, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate. (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04335669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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