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Comparing chemotherapy treatments for early triple negative breast cancer

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

Phase 3 Interventional Lund University Hospital · NCT04335669

This study is testing whether adding capecitabine to standard chemotherapy helps people with early triple negative breast cancer respond better to treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment325 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorLund University Hospital Academic / other
Drugs / interventionschemotherapy, Pembrolizumab
Locations24 sites (Vejle, Region Syd and 23 other locations)
Trial IDNCT04335669 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of adding capecitabine to a carboplatin-based preoperative chemotherapy regimen in patients with early-stage triple negative breast cancer (TNBC). It will assess the rate of pathological complete response (pCR) after treatment, comparing two cohorts: one receiving standard chemotherapy and the other receiving chemotherapy with pembrolizumab. Additionally, the study will investigate how the treatments' effects vary based on the homologous repair deficiency (HRD) status of the tumors. The primary endpoint is the pCR rate, which will be analyzed across both cohorts.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed unilateral ER-negative and HER2-normal breast cancer who are planning to undergo neoadjuvant chemotherapy.

Not a fit: Patients with ER-positive or HER2-positive breast cancer, or those with other types of breast cancer not meeting the eligibility criteria, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with early-stage triple negative breast cancer by identifying more effective chemotherapy combinations.

How similar studies have performed: Previous studies have shown promise in using similar chemotherapy regimens for TNBC, but this specific combination and its focus on HRD status is a novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Vejle, Region Syd and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerTriple Negative Breast NeoplasmsBreast neoplasmsTriple negative breast neoplasmsNeoadjuvant treatmentTranslational researchPathologic responsePathologic complete response
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.