Metastatic Breast CancerPhase 3NCT06835400
Oral Paclitaxel + Encequidar vs IV Paclitaxel in Treatment of HER2 Negative Metastatic Breast Cancer
A Phase 3 study testing Paclitaxel Capsule, IV Paclitaxel and Encequidar tablet in people with Metastatic Breast Cancer, run by Health Hope Pharma.
Trial summary
The current study is being conducted to find an optimal Oral Paclitaxel + Encequidar dose and regimen based on prior experience with oral paclitaxel (stage 1) and to compare that dose to an accepted dose and regimen of intravenous (IV) paclitaxel in subjects with metastatic breast cancer (stage 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Paclitaxel Capsule, IV Paclitaxel and Encequidar tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2029
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- ≥18 years of age
- Histologically or cytologically confirmed HER2 negative breast cancer for whom IV paclitaxel monotherapy has been recommended.
- HER2 negative per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guideline. Subjects can be estrogen receptor/progesterone receptor (ER/PR) positive or negative per ASCO CAP guideline, but ER/PR and HER2 receptor status must be known.
- Metastatic breast cancer with target lesions measurable by CT scan per RECIST v1.1 criteria confirmed by BICR
- Adequate hematologic status as demonstrated by not requiring granulocyte colony stimulating factor (G CSF) or transfusion support within 30 days prior to randomization to achieve the following at screening:
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- Absolute neutrophil count (ANC) ≥1500/mm3
- Platelet count ≥100,000/mm3
- Hemoglobin ≥9 g/dL
- Adequate liver function as demonstrated by:
- Total bilirubin ≤upper limit of normal (ULN) unless the subject has Gilbert's disease, for which bilirubin must be ≤2.0 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN
- Adequate renal function as demonstrated by estimated glomerular filtration rate (eGFR) ≥60 mL/min
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 6 months, in the judgment of the Investigator
- Female subjects must be postmenopausal (≥12 months without menses) or surgically sterile (ie, by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or must be using effective contraception (ie, non-hormonal intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
- Women of childbearing potential must have a negative screening serum pregnancy test and urine test within 4 days prior to start of dosing in the study and not be breast feeding.
- Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of investigational product (IP).
Who cannot join
- Not recovered to ≤grade 1 toxicity from previous anticancer treatments or previous investigational product (IP) except alopecia
- QTcF interval ≥470 msec at baseline
- Relapsed less than 6 months following treatment with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease
- Known active central nervous system metastasis, including leptomeningeal involvement
- Currently receiving other medications intended for the treatment of their malignancy
- Received other IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
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- Received biologics or monoclonal antibodies intended for the treatment of their malignancy within 30 days of the first study dosing day
- Received radiation therapy within 2 weeks prior to signing informed consent or radiation therapy is planned within 6 months from the time of signing informed consent
- Taking a medication known to be a moderate or strong cytochrome P450 (CYP) 3A4 inhibitor or inducer or neurokinin-1 receptor antagonist (NK-1) inhibitor within 14 days prior to start of dosing in the study
- Taking a medication known to be a moderate or strong CYP2C8 inhibitor or inducer within 14 days prior to start of dosing in the study
- Taking an oral medication with a narrow therapeutic index known to be a P-glycoprotein (P-gp) substrate within 24 hours prior to start of dosing in the study
- Taking a medication known to be a P-gp inhibitor or inducer within 14 days prior to start of dosing in the study
- Taking a medication known to be an organic anion transporting polypeptide 1B1/3 (OATP1B1/3) inhibitor
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
- Major surgery to the upper GI tract, inability to take oral medication, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption
- History of significant hypersensitivity-type reaction to paclitaxel or Cremophor EL that would contraindicate the use of IV paclitaxel
- Known allergic reaction or intolerance to contrast media
- Documented history of true systemic allergic reaction to 3 or more medications
- Active hepatitis B (as evidenced by being HBsAg positive) or active hepatitis C (HCV-RNA positive) or cirrhosis of the liver
- Known HIV infection
- The Investigator believes that participation in this study would not be acceptable
About this study
Official title: An Open-Label, Randomized, Two-stage Study to Determine Dose Optimization, Safety, and Noninferiority of Oral Paclitaxel + Encequidar Compared to IV Paclitaxel in Subjects With HER2 Negative Metastatic Breast Cancer
The current study is being conducted to find an optimal Oral Paclitaxel + Encequidar dose and regimen based on prior experience with oral paclitaxel (stage 1) and to compare that dose to an accepted dose and regimen of intravenous (IV) paclitaxel in subjects with metastatic breast cancer (stage 2).
- Conditions
- Metastatic Breast Cancer
- Being tested
- Paclitaxel Capsule, IV Paclitaxel, Encequidar tablet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel CapsuleDrug
Paclitaxel Capsule
IV PaclitaxelDrug
IV Paclitaxel
Encequidar tabletDrug
Encequidar tablet
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar | Experimental | A minimum of 20 subjects per group will be centrally randomized 1:1 to Oral Paclitaxel 165 mg/m2 + Encequidar 3 weeks of a 4-week cycle (3/4) or Oral Paclitaxel 205 mg/m2 (3/4) + Encequidar. Receives: Drug: Paclitaxel Capsule; Drug: Encequidar tablet |
| Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar | Experimental | A minimum of 20 subjects per group will be centrally randomized 1:1 to Oral Paclitaxel 165 mg/m2 + Encequidar 3 weeks of a 4-week cycle (3/4) or Oral Paclitaxel 205 mg/m2 (3/4) + Encequidar. Receives: Drug: Paclitaxel Capsule; Drug: Encequidar tablet |
| Stage 2: Oral Paclitaxel + Encequidar | Experimental | Not described Receives: Drug: Paclitaxel Capsule; Drug: Encequidar tablet |
| Stage 2: IV Paclitaxel | Active comparator | Not described Receives: Drug: IV Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Confirmed Tumor Response
Confirmed tumor response based on BICR timepoint evaluations of CT scans using RECIST v1.1 criteria
Measured: 6 months
Stage 2: Confirmed Tumor Response
Confirmed tumor response based on BICR timepoint evaluations of CT scans using RECIST v1.1 criteria
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study startSep 2025 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HHP-ORAX-300 is a Phase 3, open-label, randomized, two-stage dose optimization and noninferiority study. The study includes 2 stages: Stage 1 is a dose-optimization design that will select an Oral Paclitaxel + Encequidar regimen to test against IV paclitaxel 80 mg/m2 in a confirmatory Stage 2.
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Hope Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835400
- Sponsor's protocol ID
- HHP-ORAX-300
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-stage Study to Determine Dose Optimization, Safety, and Noninferiority of Oral Paclitaxel + Encequidar Compared to IV Paclitaxel in Subjects With HER2 Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06835400
- Acronym / sponsor ID
- HHP-ORAX-300
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Health Hope PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 19 Feb 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 current study is being conducted to find an optimal Oral Paclitaxel + Encequidar dose and regimen based on prior experience with oral paclitaxel (stage 1) and to compare that dose to an accepted dose and regimen of intravenous (IV) paclitaxel in subjects with metastatic breast cancer (stage 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- HHP-ORAX-300 is a Phase 3, open-label, randomized, two-stage dose optimization and noninferiority study. The study includes 2 stages: Stage 1 is a dose-optimization design that will select an Oral Paclitaxel + Encequidar regimen to test against IV paclitaxel 80 mg/m2 in a confirmatory Stage 2.
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar | Experimental | Drug: Paclitaxel Capsule, Drug: Encequidar tabletA minimum of 20 subjects per group will be centrally randomized 1:1 to Oral Paclitaxel 165 mg/m2 + Encequidar 3 weeks of a 4-week cycle (3/4) or Oral Paclitaxel 205 mg/m2 (3/4) + Encequidar. |
| Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar | Experimental | Drug: Paclitaxel Capsule, Drug: Encequidar tabletA minimum of 20 subjects per group will be centrally randomized 1:1 to Oral Paclitaxel 165 mg/m2 + Encequidar 3 weeks of a 4-week cycle (3/4) or Oral Paclitaxel 205 mg/m2 (3/4) + Encequidar. |
| Stage 2: Oral Paclitaxel + Encequidar | Experimental | Drug: Paclitaxel Capsule, Drug: Encequidar tablet |
| Stage 2: IV Paclitaxel | Active comparator | Drug: IV Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed written informed consent
- ≥18 years of age
- Histologically or cytologically confirmed HER2 negative breast cancer for whom IV paclitaxel monotherapy has been recommended.
- HER2 negative per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guideline. Subjects can be estrogen receptor/progesterone receptor (ER/PR) positive or negative per ASCO CAP guideline, but ER/PR and HER2 receptor status must be known.
- Metastatic breast cancer with target lesions measurable by CT scan per RECIST v1.1 criteria confirmed by BICR
Key exclusion criteria (21 listed)
- Not recovered to ≤grade 1 toxicity from previous anticancer treatments or previous investigational product (IP) except alopecia
- QTcF interval ≥470 msec at baseline
- Relapsed less than 6 months following treatment with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease
- Known active central nervous system metastasis, including leptomeningeal involvement
- Currently receiving other medications intended for the treatment of their malignancy
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 |
|---|---|---|
| Paclitaxel CapsulePaclitaxel Capsule | Drug | Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar, Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar, Stage 2: Oral Paclitaxel + Encequidar |
| IV PaclitaxelIV Paclitaxel | Drug | Stage 2: IV Paclitaxel |
| Encequidar tabletEncequidar tablet | Drug | Stage 1: Oral Paclitaxel 165 mg/m2 + Encequidar, Stage 1: Oral Paclitaxel 205 mg/m2 + Encequidar, Stage 2: Oral Paclitaxel + Encequidar |
Primary outcome
Stage 1: Confirmed Tumor Response
Time frame: 6 months
Confirmed tumor response based on BICR timepoint evaluations of CT scans using RECIST v1.1 criteria
Stage 2: Confirmed Tumor Response
Time frame: 1 Year
Confirmed tumor response based on BICR timepoint evaluations of CT scans using RECIST v1.1 criteria
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 11 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel Capsule, IV Paclitaxel and Encequidar tablet in people with Metastatic Breast Cancer, run by Health Hope Pharma.
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 18 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: opening soon, as of the sponsor's last update on 11 Jul 2025. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Stage 1: Confirmed Tumor Response (time frame: 6 months). 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 11 Jul 2025.