Breast CancerPhase 4TNBNOBANCT06920810
Viscum Album for TNBC on Adjuvant Pembrolizumab
A Phase 4 study testing viscum album in people with Breast Cancer and Triple Negative Breast Cancer, run by Ilsan Cha hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- viscum album
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Mar 2025to 31 Dec 2028
- Phase
- Phase 4
- 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
- Adults aged 19 years or older
- Histologically confirmed diagnosis of triple-negative breast cancer
- ECOG Performance Status of 0 or 1
- Completed surgery and radiotherapy for localized disease, and either (a) requires adjuvant chemotherapy including immune checkpoint inhibitors, or (b) has initiated such therapy within 3 cycles
- Laboratory values meeting the following criteria:
- Absolute Neutrophil Count (ANC) ≥ 1,500/μL Platelet count (PLT) ≥ 100,000/μL Hemoglobin (Hb) ≥ 9.0 g/dL Albumin ≥ 3.0 g/dL Acceptable levels of creatinine, total bilirubin, AST, and ALT ≤ 3 × upper limit of normal (ULN)
- Able to understand the study information and voluntarily provide written informed consent
Who cannot join
- Presence of distant metastasis
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function
- Pregnant or breastfeeding women
- Estimated life expectancy of less than 3 months, making adequate follow-up unlikely
- Any other medical condition that may interfere with study results or any situation in which, in the investigator's judgment, participation is not appropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ilsan Cha Hospital
Goyang-si, Gyeonggi-do, 082-10414
Myung Han Hyun, 082-31-782-3113, myunghanmd1@chamc.co.kr
Jee Young Lee, 082-31-782-3113, happiade@chamc.co.kr
About this study
Official title: Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery.
The main questions it aims to answer are:
Does the addition of Viscum album improve clinical outcomes when combined with pembrolizumab as adjuvant chemotherapy? Is Viscum album safe and tolerable for use in this patient population?
Read the detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery.
This clinical trial aims to recruit 40 adult participants aged 19 years or older who have been diagnosed with malignant neoplasm of the unilateral breast and require adjuvant chemotherapy, including immune checkpoint inhibitors, after completing surgical tumor resection and radiotherapy.
Potential participants will receive a full explanation of the study's purpose and procedures and will voluntarily provide written informed consent. After screening for eligibility based on inclusion and exclusion criteria, only those who meet the criteria will be enrolled and proceed with the study.
Participants in the treatment group will receive Viscum album concurrently with pembrolizumab as part of their adjuvant chemotherapy regimen for 18 weeks in order to evaluate the efficacy and safety of Viscum album. Participants in the waitlist control group will undergo scheduled assessments without any additional intervention for the first 18 weeks, followed by a 4-week intervention phase starting from week 19.
Researchers will compare the treatment group receiving pembrolizumab plus 18 weeks of Viscum album to the waitlist control group, who will not receive any intervention for the first 18 weeks, to see if early administration of Viscum album leads to better outcomes compared to delayed intervention.
Participants will:
Sign informed consent after receiving full explanation of the study Be screened for eligibility based on inclusion and exclusion criteria If eligible, participants will be assigned to either the treatment or control group Receive subcutaneous injections of Viscum album three times per week for 18 weeks (treatment group only) Undergo scheduled clinical assessments throughout the study period
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- viscum album
- Keywords
- triple negative breast cancer, adjuvant chemotherapy, pembrolizumab, mistletoe
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viscum albumDrug
Active Ingredient: Viscum album Excipients: Ascorbic acid, disodium phosphate dihydrate, monosodium phosphate monohydrate Formulation: Injectable solution contained in a colorless ampoule; the solution is colorless to pale yellow and clear.
Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation according to the following protocol.
| Study group | Role | What they receive |
|---|---|---|
| Viscum album group | Experimental | Viscum album Active Ingredient: Viscum album Formulation: a colorless ampoule; the solution is colorless to pale yellow and clear.
Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation Receives: Drug: viscum album |
| Wait-list control group | No intervention | Participants assigned to the waitlist control group will receive pembrolizumab monotherapy as part of their standard adjuvant chemotherapy regimen without additional investigational intervention for the first 18 weeks of the study. On week 19, Participants will begin Viscum album administration for four weeks, as the same schedule with the Viscum album group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine panel
the result of immune-related cytokine panel kit (CCL2, CCL3, CCL4, CD40 Ligand, CXCL10, GM-CSF, Granzyme B, IFN-α, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-4, IL-6, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17, IL-33, PD-L1, TNF-α)
Measured: week 1, week 4, week 7, week 19
Secondary outcomes (3)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
The EORTC QLQ-C30 is a validated, widely used questionnaire developed by the European Organisation for Research and Treatment of Cancer to assess health-related quality of life in cancer patients. It includes 30 items covering functional status, symptoms, and global health and has been validated across multiple languages and cancer populations.
Measured: week 1, week 4, week 7, week 19
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast 23
The EORTC QLQ-BR23 is a validated breast cancer-specific module designed to be used alongside the EORTC QLQ-C30. It includes 23 items that assess breast cancer-related symptoms, treatment side effects, body image, and sexual functioning, and has been validated in diverse cultural and clinical settings.
Measured: week 1, week 4, week 7, week 19
MD Anderson Symptom Inventory - core
The MD Anderson Symptom Inventory (MDASI) is a validated patient-reported outcome measure developed by MD Anderson Cancer Center to assess the severity of cancer-related symptoms and their impact on daily functioning. It consists of 13 symptom severity items and 6 interference items.
Measured: week 1, week 4, week 7, week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start19 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- viscum album group added on adjuvant pembrolizumab and adjuvant pembrolizumab monotherapy group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilsan Cha hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Han Hyun, Ilsan Cha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920810
- Sponsor's protocol ID
- ICICC-CT-24-02
- Acronym
- TNBNOBA
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data due to institutional policy and/or the sensitive nature of the clinical data collected. Future sharing may be considered on a case-by-case basis pending appropriate approvals.
Publications
Lee JY, Ko EJ, Lee SH, Hong SE, Hyun MH. Efficacy and Safety of Viscum album L. in Patients With Triple-Negative Breast Cancer Receiving Immune Checkpoint Inhibitors: A Protocol for an Open-Label Randomized Clinical Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261483616. doi: 10.1177/15347354261483616. Epub 2026 Aug 27.
PubMed 42657864
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Viscum Album in Patients With Triple-negative Breast Cancer Undergoing Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06920810
- Acronym / sponsor ID
- TNBNOBA / ICICC-CT-24-02
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- triple negative breast cancer, adjuvant chemotherapy, pembrolizumab, mistletoe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ilsan Cha hospitalUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery.
The main questions it aims to answer are:
Does the addition of Viscum album improve clinical outcomes when combined with pembrolizumab as adjuvant chemotherapy? Is Viscum album safe and tolerable for use in this patient population?
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed with malignant neoplasm of unilateral breast and have completed surgery.
This clinical trial aims to recruit 40 adult participants aged 19 years or older who have been diagnosed with malignant neoplasm of the unilateral breast and require adjuvant chemotherapy, including immune checkpoint inhibitors, after completing surgical tumor resection and radiotherapy.
Potential participants will receive a full explanation of the study's purpose and procedures and will voluntarily provide written informed consent. After screening for eligibility based on inclusion and exclusion criteria, only those who meet the criteria will be enrolled and proceed with the study.
Participants in the treatment group will receive Viscum album concurrently with pembrolizumab as part of their adjuvant chemotherapy regimen for 18 weeks in order to evaluate the efficacy and safety of Viscum album. Participants in the waitlist control group will undergo scheduled assessments without any additional intervention for the first 18 weeks, followed by a 4-week intervention phase starting from week 19.
Researchers will compare the treatment group receiving pembrolizumab plus 18 weeks of Viscum album to the waitlist control group, who will not receive any intervention for the first 18 weeks, to see if early administration of Viscum album leads to better outcomes compared to delayed intervention.
Participants will:
Sign informed consent after receiving full explanation of the study Be screened for eligibility based on inclusion and exclusion criteria If eligible, participants will be assigned to either the treatment or control group Receive subcutaneous injections of Viscum album three times per week for 18 weeks (treatment group only) Undergo scheduled clinical assessments throughout the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- viscum album group added on adjuvant pembrolizumab and adjuvant pembrolizumab monotherapy group
| Arm | Type | Receives |
|---|---|---|
| Viscum album group | Experimental | Drug: viscum albumViscum album Active Ingredient: Viscum album Formulation: a colorless ampoule; the solution is colorless to pale yellow and clear. Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation |
| Wait-list control group | No intervention | –Participants assigned to the waitlist control group will receive pembrolizumab monotherapy as part of their standard adjuvant chemotherapy regimen without additional investigational intervention for the first 18 weeks of the study. On week 19, Participants will begin Viscum album administration for four weeks, as the same schedule with the Viscum album group. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 19 years or older
- Histologically confirmed diagnosis of triple-negative breast cancer
- ECOG Performance Status of 0 or 1
- Completed surgery and radiotherapy for localized disease, and either (a) requires adjuvant chemotherapy including immune checkpoint inhibitors, or (b) has initiated such therapy within 3 cycles
- Laboratory values meeting the following criteria:
Key exclusion criteria (6 listed)
- Presence of distant metastasis
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Other non-cancer comorbidities (e.g., dementia, cerebrovascular disease, end-stage renal disease) that are expected to significantly impair physical function
- Pregnant or breastfeeding women
- Estimated life expectancy of less than 3 months, making adequate follow-up unlikely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| viscum albumActive Ingredient: Viscum album Excipients: Ascorbic acid, disodium phosphate dihydrate, monosodium phosphate monohydrate Formulation: Injectable solution contained in a colorless ampoule; the solution is colorless to pale yellow and clear. Manufacturer: LB Abnoba Co., Ltd. Dosage and Administration: Administered subcutaneously three times per week, with dose escalation according to the following protocol. | Drug | Viscum album group |
Primary outcome
cytokine panel
Time frame: week 1, week 4, week 7, week 19
the result of immune-related cytokine panel kit (CCL2, CCL3, CCL4, CD40 Ligand, CXCL10, GM-CSF, Granzyme B, IFN-α, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-4, IL-6, IL-8, IL-9, IL-10, IL-12 p70, IL-13, IL-15, IL-17, IL-33, PD-L1, TNF-α)
3 secondary outcomes
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Time frame: week 1, week 4, week 7, week 19
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast 23
Time frame: week 1, week 4, week 7, week 19
MD Anderson Symptom Inventory - core
Time frame: week 1, week 4, week 7, week 19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 42657864Lee JY, Ko EJ, Lee SH, Hong SE, Hyun MH. Efficacy and Safety of Viscum album L. in Patients With Triple-Negative Breast Cancer Receiving Immune Checkpoint Inhibitors: A Protocol for an Open-Label Randomized Clinical Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261483616. doi: 10.1177/15347354261483616. Epub 2026 Aug 27.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data due to institutional policy and/or the sensitive nature of the clinical data collected. Future sharing may be considered on a case-by-case basis pending appropriate approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing viscum album in people with Breast Cancer and Triple Negative Breast Cancer, run by Ilsan Cha hospital 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Jee Young Lee, MD(KMD), PhD (082-31-782-3113, happiade@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine panel (time frame: week 1, week 4, week 7, week 19). 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 NCT06920810, which also lists 1 linked publication.
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 10 Apr 2025.