Triple Negative Breast CancerPhase 1/2NCT02802423
Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.
A Phase 1/2 study testing BLEX 404 Oral Liquid in people with Triple Negative Breast Cancer, run by BioLite, Inc..
Trial summary
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- BLEX 404 Oral Liquid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 28 Aug 2028
- Phase
- Phase 1/2
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 20 - 70 years old at the time of signing the ICF.
- Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.
- ER =< 10% by immunohistochemistry (IHC) tumor staining;
- PR =< 10% by IHC tumor staining;
- HER2-negative defined as one of the following: 0 or 1+ by IHC, or 2+ by IHC and fluorescence in situ hybridization (FISH)-negative (ratio < 2.0).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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- Adequate hematologic function defined as: absolute neutrophil count (ANC) greater than or equal to 2,000/μL; platelets count greater than or equal to 100,000/μL; hemoglobin must be greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion).
- Adequate hepatic function defined as: serum bilirubin less than or equal to 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than or equal to 3-fold ULN.
- Adequate renal function with: serum creatinine less than or equal to 1.3 mg/dL or calculated creatinine clearance greater than or equal to 60 mL/minute according to the Cockcroft and Gault formula.
- Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), from time of Screening Visit until 30 days after study drug discontinuation.
- Planning to receive Docetaxel monotherapy.
- Willing and able to comply with all aspects of the treatment protocol.
- Provide written informed consent.
Who cannot join
- Patient with brain metastasis.
- Patient with autoimmune disease that requires systemic steroids or immunosuppression agents.
- Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
- Patients with following treatment prior to Docetaxel monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior taxanes; radiation therapy within 28 days (3 months for bone marrow exposure 20%); hormonal therapy within 4 weeks.
- Known history of human immunodeficiency virus (HIV) infection.
- Existing anticancer treatment-related toxicities of Grades greater than or equal to 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
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- Patients with Grade > 2 neuropathy.
- Patient has an active infection requiring systemic therapy.
- History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study.
- Clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT/QTc ([QT interval/corrected QT interval].
- Ascertained hypersensitivity to any component of investigational product used in the study.
- Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily BLEX 404 Oral Liquid treatment.
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase IIA Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid With Adjuvant Chemotherapy in Patients With Triple Negative Breast Cancer (TNBC) After Surgery
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- BLEX 404 Oral Liquid
- Keywords
- TNBC, Breast cancer, Triple negative
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLEX 404 Oral LiquidDrug
BLEX 404 Oral Liquid is administered twice daily during the Docetaxel monotherapy period. The dose of Docetaxel is 75 mg/m2 IV, 21 days a cycle.
| Study group | Role | What they receive |
|---|---|---|
| BLEX 404 Oral Liquid | Experimental | During Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Docetaxel monotherapy among 6 patients in the Phase I study. Receives: Drug: BLEX 404 Oral Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Dose-limiting toxicity (DLT) observation
Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Docetaxel monotherapy to determine the recommended dose level (RDL).
Measured: 3 weeks (1 cycle)
Phase II: Overall response rate (PR + CR)
Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Docetaxel monotherapy.
Measured: 12 weeks (4 cycles)
Secondary outcomes (3)
Phase II: Overall response rate (PR + CR)(at least 1 cycle)
Overall response rate (PR + CR) after at least 1 cycle of combination use in BLEX 404 + Docetaxel monotherapy.
Measured: at least 3 weeks (1 cycle)
Phase II: Incidence of grade 3/4 hematological toxicity
Rate of grade 3/4 hematological toxicity of each cycle.
Measured: 3 weeks (1 cycle)
Quality of Life by EORTC QLQ-C30
Examination of quality of life by EORTC QLQ-C30 questionnaire of each cycle.
Measured: 3 weeks (1 cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start1 Jan 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion28 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLite, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard King, Ph.D., Study director, American BriVision Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802423
- Sponsor's protocol ID
- BLI-1401-2-01
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2016
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase IIA Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid With Adjuvant Chemotherapy in Patients With Triple Negative Breast Cancer (TNBC) After Surgery
- ClinicalTrials.gov ID
- NCT02802423
- Acronym / sponsor ID
- BLI-1401-2-01
- Conditions
- Triple Negative Breast Cancer
- Keywords
- TNBC, Breast cancer, Triple negative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- BioLite, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 28 Aug 2028 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- 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 primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLEX 404 Oral Liquid | Experimental | Drug: BLEX 404 Oral LiquidDuring Phase I study (dose escalation), a standard 3+3 design will be followed, and the dose range is 3 to 10 mg/kg BID. The recommended dose level (RDL) for the Phase II study is defined as the dose level with 0 to 1 DLT observed during cycle I of Docetaxel monotherapy among 6 patients in the Phase I study. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Females aged 20 - 70 years old at the time of signing the ICF.
- Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematologic function defined as: absolute neutrophil count (ANC) greater than or equal to 2,000/μL; platelets count greater than or equal to 100,000/μL; hemoglobin must be greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion).
- Adequate hepatic function defined as: serum bilirubin less than or equal to 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than or equal to 3-fold ULN.
Key exclusion criteria (13 listed)
- Patient with brain metastasis.
- Patient with autoimmune disease that requires systemic steroids or immunosuppression agents.
- Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
- Patients with following treatment prior to Docetaxel monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior taxanes; radiation therapy within 28 days (3 months for bone marrow exposure 20%); hormonal therapy within 4 weeks.
- Known history of human immunodeficiency virus (HIV) infection.
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 |
|---|---|---|
| BLEX 404 Oral LiquidBLEX 404 Oral Liquid is administered twice daily during the Docetaxel monotherapy period. The dose of Docetaxel is 75 mg/m2 IV, 21 days a cycle. | Drug | BLEX 404 Oral Liquid |
Primary outcome
Phase I: Dose-limiting toxicity (DLT) observation
Time frame: 3 weeks (1 cycle)
Presence or absence of dose-limiting toxicity (DLT) related to BLEX 404 Oral Liquid for each patient during first cycle of Docetaxel monotherapy to determine the recommended dose level (RDL).
Phase II: Overall response rate (PR + CR)
Time frame: 12 weeks (4 cycles)
Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 + Docetaxel monotherapy.
3 secondary outcomes
Phase II: Overall response rate (PR + CR)(at least 1 cycle)
Time frame: at least 3 weeks (1 cycle)
Phase II: Incidence of grade 3/4 hematological toxicity
Time frame: 3 weeks (1 cycle)
Quality of Life by EORTC QLQ-C30
Time frame: 3 weeks (1 cycle)
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 13 Apr 2026.
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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.
Richard King, Ph.D. study director
American BriVision Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BLEX 404 Oral Liquid in people with Triple Negative Breast Cancer, run by BioLite, Inc..
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 13 inclusion and 13 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Hsien-Ming Wu, Master (886-3-657-9631 ext. 13, sonnywu@bioliteinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Dose-limiting toxicity (DLT) observation (time frame: 3 weeks (1 cycle)). 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?
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 13 Apr 2026.