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Could adding capecitabine boost chemo success in Triple-Negative breast cancer?

NCT ID NCT04335669

Disease control Sponsor: Lund University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests whether adding the drug capecitabine to standard chemotherapy improves outcomes for people with early triple-negative breast cancer. The study involves 325 participants and aims to see if the combination leads to a higher rate of complete tumor disappearance before surgery. Pembrolizumab is also allowed in both treatment groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
capecitabine (added to standard chemotherapy drugs epirubicin, cyclophosphamide, paclitaxel, carboplatin, and pembrolizumab)
What this could lead to
If successful, this could lead to a more effective chemotherapy regimen for early triple-negative breast cancer, potentially increasing the chance of a complete response before surgery.
What could go wrong
This is a phase 3 trial, but results are not yet available. Adding capecitabine may increase side effects without improving outcomes, and the study only includes specific patient types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 325 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Sep 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Pathologic Complete Response triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Triple negative breast neoplasms

Contacts and locations

Locations

  • Aalborg Universitetshospita

    Aalborg, 9000, Denmark

  • Academical Hospital, Department of Oncology

    Uppsala, 753 09, Sweden

  • Capio S:t Göran Hospital, Department of Oncology

    Stockholm, 112 19, Sweden

  • Centralsjukhuset i Kristianstad

    Kristianstad, Skåne County, 291 85, Sweden

  • Gävle hospital, Department of Oncology

    Gävle, 803 24, Sweden

  • Halmstad Hospital, Department of Surgery

    Halmstad, 302 33, Sweden

  • Karlstad Hospital

    Karlstad, 652 30, Sweden

  • Nordsjællands Hospital

    Hillerød, 3400, Denmark

  • Norrland University Hospital, Department of Oncology

    Umeå, 907 37, Sweden

  • Regionsjælland Næstved Sygehus

    Næstved, 4700, Denmark

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Ryhov Hospital

    Jönköping, 551 85, Sweden

  • Sahlgrenska University Hospital, Department of Oncology

    Gothenburg, 413 46, Sweden

  • Skåne University Hospital, Department of Oncology

    Malmö, 20501, Sweden

  • Sundsvall hospital

    Sundsvall, 851 86, Sweden

  • Sydvestjysk Sygehus

    Esbjerg, 6700, Denmark

  • Södersjukhuset, Department of Oncology

    Stockholm, 118 61, Sweden

  • Södra Älvsborgs Hospital

    Borås, 501 82, Sweden

  • Sønderborg sygehus

    Sønderborg, 6300, Denmark

  • Vejle Hospital

    Vejle, Region Syd, 7100, Denmark

  • Vejle syghus

    Vejle, 7100, Denmark

  • Västmanlands Hopsital Västerås

    Västerås, 721 89, Sweden

  • Växjö Hospital, Department of Oncology

    Vaxjo, 352 34, Sweden

  • Örebro University Hospital, Department of Oncology

    Örebro, 701 85, Sweden

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