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Triple Negative Breast CancerPhase 2NCT03756298

Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

A Phase 2 study testing Atezolizumab and Capecitabine in people with Triple Negative Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Active, not recruiting

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

Official record
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Trial summary

This study will enroll patients who received neoadjuvant therapy for TNBC prior to surgery and did not get pCR. Given the relatively poor prognosis for these patients, this population is considered novel therapeutic as adjuvant treatment. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Atezolizumab and Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteSouth Korea
Study dates
15 Jan 2019to 31 Dec 2027
Phase
Phase 2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - Male or female ≥ 19 years of age
  • Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative) with residual invasive breast cancer, as defined by the 2010 and 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Wolff AC, Hammond MEH), after completion of neoadjuvant chemotherapy; residual disease must be ≥ 1 cm in greatest dimension, and/or have macroscopically positive lymph nodes (ypN+) observed on pathologic exam
  • Patients must not have metastatic disease (i.e., must be M0)
  • Patients must have a minimum of 20, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node to be submitted to determine PD-L1 expression and other biomarker analysis
  • Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer. Patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease
  • Patients must have completed their final breast surgery with clear resection margins for invasive cancer and ductal carcinoma in situ (DCIS) within 90 days prior to screening
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  • Patients for whom radiation therapy (RT) to the affected breast or chest wall and regional nodal areas is clinically indicated as per NCCN treatment guidelines, should receive RT before study treatment; RT administered after registration is also allowed
  • Patients must have resolution of adverse event(s) of the most recent prior chemotherapy and RT to grade 1 or less, except alopecia and ≤ grade 2 neuropathy which are allowed
  • Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs
  • Patients must not have had prior capecitabine therapy.
  • Patients must not have had a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • Patients must have ECOG performance status < 2
  • Patients must sign and give written informed consent for this protocol in accordance with institutional guidelines
  • Patients should have adequate organ function within 21 days prior to the start of study treatment (cycle 1, day1).
  • Absolute neutrophil count (ANC) ≥ 1500/uL; without granulocyte colony stimulating factor (G-CSF) support within 2 weeks prior to the first study treatment administration
  • Lymphocyte count ≥ 500/uL
  • Platelet count ≥ 100,000/uL (without transfusion within 2 weeks prior to the first study treatment administration)
  • Hemoglobin ≥ 9.0g/dL
  • AST, ALT, and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN)
  • Serum bilirubin ≤ 1.5x ULN, patients with known Gilbert disease who have serum bilirubin ≤ 3.0x ULN may be enrolled.
  • INR and aPTT ≤ 1.5x ULN, This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
  • Calculated creatinine clearance ≥ 30mL/min
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 28 day prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 150 days after the last dose of study medication.

Who cannot join

  • - Patients with evident metastatic lesions at the time of diagnosis
  • Patients who underwent incomplete surgery for breast cancer
  • Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with well-differentiated thyroid cancer, carcinoma in situ of the cervix or basal or squamous cell skin cancer.
  • Pregnancy or lactation
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol including significant liver disease, uncontrolled major seizure disorder, or uncontrolled psychological disorder.
  • Significant cardiovascular disease, such as New York Hear Association (NYHA) cardiac disease (class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmia, or unstable angina.
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  • : Patients with a known left ventricular ejection fraction (LVEF) <50% will be excluded.
  • Patients who have a history of interstitial pneumonitis that required steroids or evidence of active pneumonitis.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in patients selected to receive capecitabine
  • Hypersensitivity to any component of capecitabine drug formulation in patients selected to receive capecitabine.
  • Patients who have an active infection requiring systemic therapy
  • Patients who have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); patients who are on a stable dose of replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are eligible for this study
  • Patients who have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration; patients who have completed curative therapy for HCV are eligible; patients with known human immunodeficiency virus (HIV) infection are not eligible
  • Patients who have received live vaccines within 30 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
  • Known hypersensitivity to any of excipients of study drugs.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  • Prior allogenic stem cell or solid organ transplantation
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug( whichever is shorter) prior to randomization
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents etc.) within 2 weeks prior to randomization
  • patients who have received acute, low-dose, systemic immunosuppressant medications may be enrolled in the study
  • The use of inhaled corticosteroids for chronic obstructive pulmonary disease, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University, Guro hospital

    Seoul, 08308

Other trials in South Korea

About this study

Official title: Randomized, Phase II Trial to Evaluate the Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy Compared to Capecitabine Monotherapy for TNBC With Residual Invasive Cancer After Neoadjuvant Chemotherapy.

This study will enroll patients who received neoadjuvant therapy for TNBC prior to surgery and did not get pCR. Given the relatively poor prognosis for these patients, this population is considered novel therapeutic as adjuvant treatment. Currently, capecitabine monotherapy could be beneficial to this group of patients according to CREATE-X trial results. The investigators are addressing the effect of anti-PD-L1, atezolizumab combined with capecitabine in patients with TNBC who did not get pCR after neoadjuvant chemotherapy compared to capecitabine monotherapy.

Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • AtezolizumabDrug

    Also called Arm A

    Atezolizumab is 1,200 mg iv. administered every 3 weeks for 8 cycles with capecitabine (2,000mg/m2/day, day 1-14, every 3 weeks for 8 cycles)

  • CapecitabineDrug

    Also called Arm B

    capecitabine monotherapy (2,500mg/m2/day, day 1-14, every 3 weeks for 8 cycles)

Study groups in NCT03756298
Study groupRoleWhat they receive
CombinationExperimentalAtezolizumab + capecitabine combination arm
Receives: Drug: Capecitabine
ControlActive comparatorCapecitabine alone arm
Receives: Drug: Atezolizumab; Drug: Capecitabine

What is being measured

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

  1. 5-yr invasive disease-free survival (IDFS) rate

    • To compare 5-yr invasive disease-free survival (IDFS) rate of patients with triple-negative breast cancer (TNBC) who had either ≥ 1 cm residual invasive breast cancer and/or positive lymph nodes (> ypN+) after neoadjuvant chemotherapy

    Measured: 3 years after last patient enrollment

Timeline

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

  1. First posted28 Nov 2018
  2. Study start15 Jan 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03756298
Sponsor's protocol ID
ATOX-2018
Status last verified
Apr 2026
First submitted
26 Nov 2018
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Im SA, Park K, Koh J, Park C, Jung KH, Lee J, Ahn HK, Lee A, Sim SH, Kim MH, Kim JH, Kim JH, Lee KE, Park KH, Bae J, Lee MH, Lim S, Kim HJ, Lee DW, Jeong JH, Lee KS, Sohn J, Suh KJ, Kim JY, Cha YJ, Moon J, Ock CY, Kim SB, Shin K, Chae H, Kim GM, Lee KH, Park WY, Park YH, Park IH; Korean Cancer Study Group (KCSG) Breast Cancer Committee. Genomic and transcriptomic analyses of residual invasive triple-negative breast cancer after neoadjuvant chemotherapy in the prospective MIRINAE trial (a randomized phase II trial of adjuvant atezolizumab plus capecitabine compared to capecitabine; KCSG-BR18-21). ESMO Open. 2025 Oct;10(10):105804. doi: 10.1016/j.esmoop.2025.105804. Epub 2025 Sep 24.

    PubMed 40997746

  • Lee J, Ahn HK, Lee KH, Jung KH, Park YH, Sim SH, Kim MH, Kim JH, Kim JH, Lee KE, Park KH, Bae J, Lee MH, Lim S, Kim HJ, Lee DW, Jeong JH, Kim JY, Ahn JS, Lee KS, Sohn J, Suh KJ, Cha YJ, Shin K, Kim SB, Chae H, Kim GM, Im SA, Park IH; Korean Cancer Study Group (KCSG) Breast Cancer Committee. Randomized, phase II trial to evaluate the efficacy and safety of atezolizumab plus capecitabine adjuvant therapy compared to capecitabine monotherapy for triple receptor-negative breast cancer with residual invasive cancer after neoadjuvant chemotherapy (MIRINAE trial, KCSG-BR18-21). BMC Cancer. 2025 Aug 9;25(1):1295. doi: 10.1186/s12885-025-14673-0.

    PubMed 40783751

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and Capecitabine in people with Triple Negative Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

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 23 inclusion and 21 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

5-yr invasive disease-free survival (IDFS) rate (time frame: 3 years after last patient enrollment). 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 NCT03756298, which also lists 2 linked publications.

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 23 Apr 2026.

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