Advanced Breast CancerPhase 2NCT07602907
Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study
A Phase 2 study testing Paclitaxel Oral Solution (50mg/qd), Paclitaxel Oral Solution (100mg/TIW) and Paclitaxel Oral Solution (OTD) in people with Advanced Breast Cancer and HER2-negative Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- Paclitaxel Oral Solution (50mg/qd), Paclitaxel Oral Solution (100mg/TIW) and Paclitaxel Oral Solution (OTD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2026to 20 Aug 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+/HER2-negative subtype: prior treatment with at least 1 line of CDK4/6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.
- 3.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.
- Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent/metastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.
- Neoadjuvant or adjuvant therapy is not counted as a treatment line.
- Disease recurrence >6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.
- Disease recurrence >12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.
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- 4.Prior treatment with taxane is allowed if both criteria are met:
- Interval from last dose of taxane to first study dose ≥ 4 weeks;
- No unresolved taxane-related Grade ≥3 toxicity in the past. 5.Body surface area (BSA): 1.38 m² ≤ BSA ≤ 1.87 m². 6.ECOG performance status 0-1. 7.At least one measurable lesion per RECIST 1.1. 8.Expected survival ≥ 12 weeks. 9.Adequate bone marrow function: ANC ≥ 1.5 × 10⁹/L Platelets ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L 10.Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN ALT/AST ≤ 2.5 × ULN (no liver metastasis) ALT/AST ≤ 5 × ULN (with liver metastasis) 11.Adequate renal function: Serum creatinine ≤ 1.5 mg/dL Or creatinine clearance (Ccr) ≥ 60 mL/min (calculated by Cockcroft-Gault formula) if serum creatinine >1.5 mg/dL.
- 12.Pre-existing peripheral neuropathy < Grade 2 (CTCAE v6.0). 13.Known CNS metastases are allowed only if all of the following are met:
- CNS lesions stable for ≥4 weeks before enrollment, per RANO-BM criteria (no new lesions, target lesion volume change <20%, no clear progression of non-target lesions on baseline and follow-up MRI).
- No corticosteroid use, or current dexamethasone ≤4 mg/day (or equivalent), with no dose increase within 7 days before enrollment.
- For patients with prior local CNS treatment: no imaging progression after treatment completion; neurologic symptoms stable for ≥2 weeks before first study dose; no steroid or ≤4 mg/day dexamethasone (or equivalent).
- No leptomeningeal disease.
- Whole-brain radiotherapy completed >14 days before enrollment.
- Prior stereotactic radiosurgery is allowed.
- Prior CNS surgery completed >28 days before enrollment with full recovery. 14.Voluntary participation and signed written informed consent.
Who cannot join
- Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.
- Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).
- Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.
- Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence/metastasis within 12 months after neoadjuvant/adjuvant therapy.
- Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.
- Patients receiving long-term treatment with steroids or other immunosuppressive agents (except oral, topical, or local injection).
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- Patients with myocardial infarction, congestive heart failure, rapidly changing arrhythmia on ECG, severe or unstable angina pectoris, or other serious heart diseases.
- Patients with other severe medical diseases (uncontrolled diabetes mellitus and hypertension, chronic obstructive pulmonary disease (COPD), or dyspnea at rest due to any cause).
- Patients with a history of drug or alcohol abuse within the past 3 months.
- Pregnant or breastfeeding women, or patients who cannot or will not use effective contraceptive methods.
- Patients with or suspected of having bile acid excretion disorders.
- Active tendency of gastrointestinal bleeding or use of oral vitamin K antagonists (low-dose warfarin and acetylsalicylic acid are allowed as long as INR ≤2.0).
- Patients with severe hypersensitivity to the active ingredients or excipients of the study drugs.
- History of HIV seropositivity (HIV testing is not mandatory).
- Gastrointestinal dysfunction or diseases that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome), except patients with prior gastrectomy.
- Patients receiving enteral feeding (e.g., via nasogastric tube, nasointestinal tube, gastrostomy, or jejunostomy).
- Patients with visceral crisis, or patients with excessive tumor burden, rapid disease progression who urgently require rapid tumor shrinkage (e.g., conventional maximum tolerated dose chemotherapy) to relieve severe clinical symptoms per investigator assessment.
- Patients considered inappropriate for the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Lei Lei, 0571-88122146, irb@zjcc.org.cn
About this study
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments.
The main questions this study aims to answer are:
Read more
What doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment?
This study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety.
Participants will:
Receive metronomic oral paclitaxel solution according to the assigned dose schedule.
Visit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations.
Complete assessments of treatment response, side effects, and quality of life during the study.
Continue follow-up after treatment to collect information about disease status and survival.
- Being tested
- Paclitaxel Oral Solution (50mg/qd), Paclitaxel Oral Solution (100mg/TIW), Paclitaxel Oral Solution (OTD), Paclitaxel Oral Solution (150mg/TIW), Paclitaxel Oral Solution (200mg/TIW)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Oral Solution (50mg/qd)Drug
Paclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days.
Paclitaxel Oral Solution (100mg/TIW)Drug
Paclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
Paclitaxel Oral Solution (OTD)Drug
Optimal tolerated dose (OTD) of metronomic paclitaxel oral solution.Each treatment cycle is 21 days.
Paclitaxel Oral Solution (150mg/TIW)Drug
Paclitaxel oral solution, 150 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
Paclitaxel Oral Solution (200mg/TIW)Drug
Paclitaxel oral solution 200 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Metronomic Oral Paclitaxel 50 mg QD | Experimental | Not described Receives: Drug: Paclitaxel Oral Solution (50mg/qd) |
| Metronomic Oral Paclitaxel 100 mg/d TIW | Experimental | Not described Receives: Drug: Paclitaxel Oral Solution (100mg/TIW) |
| Metronomic Oral Paclitaxel （OTD） | Experimental | Not described Receives: Drug: Paclitaxel Oral Solution (OTD) |
| Metronomic Oral Paclitaxel 150 mg/d TIW | Experimental | Not described Receives: Drug: Paclitaxel Oral Solution (150mg/TIW) |
| Metronomic Oral Paclitaxel 200 mg/d TIW | Experimental | Not described Receives: Drug: Paclitaxel Oral Solution (200mg/TIW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Tolerated Dose (OTD) of metronomic oral paclitaxel
To evaluate the safety, tolerability, and Disease Control Rate (DCR) of different doses of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer, and select the Optimal Tolerated Dose (OTD) for subsequent combination therapy.
Measured: TRAE assessment: Within 7 days after the first dose DCR assessment: At the first efficacy evaluation (planned at 6 weeks after the first dose)
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1.
Measured: Up to approximately 24 months from the first dose of combination therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start4 Aug 2026 (estimated)
- Primary completion20 Aug 2029 (estimated)
- Study completion20 Aug 2029 (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 Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Lei, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602907
- Sponsor's protocol ID
- METRO - P
- Status last verified
- Aug 2026
- First submitted
- 9 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mo H, Yu Y, Sun X, Ge H, Yu L, Guan X, Zhai J, Zhu A, Wei Y, Wang J, Yan X, Qian H, Xu B, Ma F. Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial. Nat Med. 2024 Sep;30(9):2528-2539. doi: 10.1038/s41591-024-03088-2. Epub 2024 Jul 5.
PubMed 38969879
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study
- ClinicalTrials.gov ID
- NCT07602907
- Acronym / sponsor ID
- METRO - P
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 4 Aug 2026 (estimated)
- Primary completion
- 20 Aug 2029 (estimated)
- Study completion
- 20 Aug 2029 (estimated)
- First posted
- 22 May 2026 (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 safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments.
The main questions this study aims to answer are:
What doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment?
This study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety.
Participants will:
Receive metronomic oral paclitaxel solution according to the assigned dose schedule.
Visit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations.
Complete assessments of treatment response, side effects, and quality of life during the study.
Continue follow-up after treatment to collect information about disease status and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Metronomic Oral Paclitaxel 50 mg QD | Experimental | Drug: Paclitaxel Oral Solution (50mg/qd) |
| Metronomic Oral Paclitaxel 100 mg/d TIW | Experimental | Drug: Paclitaxel Oral Solution (100mg/TIW) |
| Metronomic Oral Paclitaxel （OTD） | Experimental | Drug: Paclitaxel Oral Solution (OTD) |
| Metronomic Oral Paclitaxel 150 mg/d TIW | Experimental | Drug: Paclitaxel Oral Solution (150mg/TIW) |
| Metronomic Oral Paclitaxel 200 mg/d TIW | Experimental | Drug: Paclitaxel Oral Solution (200mg/TIW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+/HER2-negative subtype: prior treatment with at least 1 line of CDK4/6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.
- 3.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.
- Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent/metastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.
- Neoadjuvant or adjuvant therapy is not counted as a treatment line.
- Disease recurrence >6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.
Key exclusion criteria (18 listed)
- Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.
- Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).
- Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.
- Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence/metastasis within 12 months after neoadjuvant/adjuvant therapy.
- Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.
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 Oral Solution (50mg/qd)Paclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days. | Drug | Metronomic Oral Paclitaxel 50 mg QD |
| Paclitaxel Oral Solution (100mg/TIW)Paclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days. | Drug | Metronomic Oral Paclitaxel 100 mg/d TIW |
| Paclitaxel Oral Solution (OTD)Optimal tolerated dose (OTD) of metronomic paclitaxel oral solution.Each treatment cycle is 21 days. | Drug | Metronomic Oral Paclitaxel （OTD） |
| Paclitaxel Oral Solution (150mg/TIW)Paclitaxel oral solution, 150 mg orally three times weekly (TIW). Each treatment cycle is 21 days. | Drug | Metronomic Oral Paclitaxel 150 mg/d TIW |
| Paclitaxel Oral Solution (200mg/TIW)Paclitaxel oral solution 200 mg orally three times weekly (TIW). Each treatment cycle is 21 days. | Drug | Metronomic Oral Paclitaxel 200 mg/d TIW |
Primary outcome
Optimal Tolerated Dose (OTD) of metronomic oral paclitaxel
Time frame: TRAE assessment: Within 7 days after the first dose DCR assessment: At the first efficacy evaluation (planned at 6 weeks after the first dose)
To evaluate the safety, tolerability, and Disease Control Rate (DCR) of different doses of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer, and select the Optimal Tolerated Dose (OTD) for subsequent combination therapy.
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months from the first dose of combination therapy
Disease control rate (DCR) is defined as the proportion of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1.
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 Aug 2026.
- Results publication: PubMed 38969879Mo H, Yu Y, Sun X, Ge H, Yu L, Guan X, Zhai J, Zhu A, Wei Y, Wang J, Yan X, Qian H, Xu B, Ma F. Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial. Nat Med. 2024 Sep;30(9):2528-2539. doi: 10.1038/s41591-024-03088-2. Epub 2024 Jul 5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel Oral Solution (50mg/qd), Paclitaxel Oral Solution (100mg/TIW) and Paclitaxel Oral Solution (OTD) in people with Advanced Breast Cancer and HER2-negative Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
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 17 inclusion and 18 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 11 Aug 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 China. 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?
Contact Lei Lei (+8613750802564, leilei@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Tolerated Dose (OTD) of metronomic oral paclitaxel (time frame: TRAE assessment: Within 7 days after the first dose DCR assessment: At the first efficacy evaluation (planned at 6 weeks after the first dose)). 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?
On the ClinicalTrials.gov record for NCT07602907, 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 11 Aug 2026.