HER2 + Breast CancerPhase 1/2GBCF002NCT07739511
Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
A Phase 1/2 study testing Paclitaxel oral solution plus Trastuzumab and Pertuzumab in people with HER2 + Breast Cancer, run by Liu Shu at 1 site in China.
Trial summary
This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2 + Breast Cancer
- What is being tested?
- Paclitaxel oral solution plus Trastuzumab and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2026to 30 Jul 2029
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18 to 70 years.
- Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).
- HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function assessed within 14 days prior to first dose of study drug, without blood transfusion or growth-factor support, meeting the following:
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- Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L; hemoglobin (Hb) ≥ 90 g/L.
- Blood chemistry: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula.
- Voluntary participation with signed informed consent, good compliance, and willingness to attend follow-up.
Who cannot join
- History of prior invasive breast cancer.
- Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and/or skin involvement and/or pathological evidence of tumor cells in dermal lymphatics).
- Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
- Prior systemic therapy for breast cancer.
- History of life-threatening hypersensitivity reaction, or known allergy to any component of the study drug.
- Participation in another drug or medical device clinical trial within 4 weeks prior to first dose, with receipt of investigational product or device.
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- Major surgery within 28 days prior to first dose, or planned major surgery during the study.
- Other malignancy within the past 5 years (except cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ).
- Active tuberculosis or other serious infectious disease, including but not limited to bacteremia, severe infectious pneumonia, or other severe infection requiring systemic therapy.
- History of immunodeficiency or other autoimmune disease, including but not limited to HIV infection (positive HIV antibody), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.
- History of any of the following cardiovascular/cerebrovascular diseases: (1) unstable angina; (2) clinically significant or medication-requiring arrhythmia; (3) myocardial infarction within 6 months; (4) heart failure, or second-degree or higher atrioventricular block; (5) cerebral infarction (except lacunar infarction) or cerebral hemorrhage within 6 months.
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite regular antihypertensive medication), or history of hypertensive crisis or hypertensive encephalopathy.
- Uncontrolled concurrent illness or condition (including significant psychiatric or social condition) that, in the investigator's judgment, may affect compliance with study procedures.
- Requirement for long-term use of proton pump inhibitors or H2 receptor antagonists during the study; or use of strong inducers or inhibitors of CYP3A4 or CYP2C8 within 2 weeks prior to first study-drug administration.
- In the investigator's judgment, subjects unsuitable or unwilling to take oral study drug: (1) clinically significant or uncontrolled congenital or acquired gastrointestinal disease; (2) diagnosed disease that may affect administration, gastrointestinal transit, or absorption of the study drug, or adherence to oral study drug, including intestinal obstruction and inflammatory bowel disease (Crohn's disease and ulcerative colitis), peptic ulcer, uncontrolled nausea, vomiting, or diarrhea; (3) presence or suspected impairment of bile secretion.
- Pregnant or lactating women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception throughout the study and for 3 months after the last dose.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yu Ren, PhD contact
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
Shu Liu, PhD, 86- 13908516963, Drliushu@163.com
Yu Ren
About this study
Official title: A Dose-Finding Study of Paclitaxel Oral Solution in Neoadjuvant Therapy for Patients With HER2-Positive Breast Cancer
This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).
- Conditions
- HER2 + Breast Cancer
- Being tested
- Paclitaxel oral solution plus Trastuzumab and Pertuzumab
- Keywords
- BF-BOIN, Oral paclitaxel, Neoadjuvant Therapy, HER2 positive, Breast cancer
- 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 oral solution plus Trastuzumab and PertuzumabCombination product
Also called THP regemin
Eligible patients in three cohorts receive 6 neoadjuvant THP cycles: paclitaxel oral solution at 125/150/175 mg/m² BID (D1, D8, D15), and dual anti-HER2 therapy - trastuzumab (8→6 mg/kg IV or 600 mg SC) and pertuzumab (840→420 mg IV), both Q3W - or, alternatively, the pertuzumab/trastuzumab SC fixed-dose combination (Phesgo; loading 1200/600 mg [15 mL], maintenance 600/600 mg [10 mL]), Q3W; all for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Dose-level 1 cohort | Experimental | The dose of paclitaxel oral solution is 125mg/m2. Receives: Combination Product: Paclitaxel oral solution plus Trastuzumab and Pertuzumab |
| Dose-level 2 cohort | Experimental | The dose of paclitaxel oral solution is 150mg/m2. Receives: Combination Product: Paclitaxel oral solution plus Trastuzumab and Pertuzumab |
| Dose-level 3 cohort | Experimental | The dose of paclitaxel oral solution is 175mg/m2. Receives: Combination Product: Paclitaxel oral solution plus Trastuzumab and Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTD)
The incidence of dose-limiting toxicitys and any AEs will be assessed. After the trial is completed, the MTD is determined with all the data based on isotonic regression by the shiny app "BF-BOIN" available at http://www.trialdesign.org.
Measured: Up to 24 weeks.
Secondary outcomes (2)
total Pathological Complete Response(tpCR)
It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Measured: Up to six months.
Overall Response Rate(ORR)
Response Evaluation Criteria in Solid Tumors (RECIST)：Progressive Disease (PD); Partial Response (PR); Complete Response (CR); Stable Disease (SD) Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) partial response (PR) to treatment.
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start29 Jul 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 + 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Shu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Shu, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739511
- Sponsor's protocol ID
- OT-2025-004
- Acronym
- GBCF002
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Finding Study of Paclitaxel Oral Solution in Neoadjuvant Therapy for Patients With HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07739511
- Acronym / sponsor ID
- GBCF002 / OT-2025-004
- Conditions
- HER2 + Breast Cancer
- Keywords
- BF-BOIN, Oral paclitaxel, Neoadjuvant Therapy, HER2 positive, Breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liu ShuUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 31 Jul 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.
This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose-level 1 cohort | Experimental | Combination Product: Paclitaxel oral solution plus Trastuzumab and PertuzumabThe dose of paclitaxel oral solution is 125mg/m2. |
| Dose-level 2 cohort | Experimental | Combination Product: Paclitaxel oral solution plus Trastuzumab and PertuzumabThe dose of paclitaxel oral solution is 150mg/m2. |
| Dose-level 3 cohort | Experimental | Combination Product: Paclitaxel oral solution plus Trastuzumab and PertuzumabThe dose of paclitaxel oral solution is 175mg/m2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, aged 18 to 70 years.
- Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).
- HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (17 listed)
- History of prior invasive breast cancer.
- Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and/or skin involvement and/or pathological evidence of tumor cells in dermal lymphatics).
- Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
- Prior systemic therapy for breast cancer.
- History of life-threatening hypersensitivity reaction, or known allergy to any component of the study drug.
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 plus Trastuzumab and PertuzumabAlso: THP regeminEligible patients in three cohorts receive 6 neoadjuvant THP cycles: paclitaxel oral solution at 125/150/175 mg/m² BID (D1, D8, D15), and dual anti-HER2 therapy - trastuzumab (8→6 mg/kg IV or 600 mg SC) and pertuzumab (840→420 mg IV), both Q3W - or, alternatively, the pertuzumab/trastuzumab SC fixed-dose combination (Phesgo; loading 1200/600 mg [15 mL], maintenance 600/600 mg [10 mL]), Q3W; all for 6 cycles. | Combination product | Dose-level 1 cohort, Dose-level 2 cohort, Dose-level 3 cohort |
Primary outcome
Maximum Tolerated Dose(MTD)
Time frame: Up to 24 weeks.
The incidence of dose-limiting toxicitys and any AEs will be assessed. After the trial is completed, the MTD is determined with all the data based on isotonic regression by the shiny app "BF-BOIN" available at http://www.trialdesign.org.
2 secondary outcomes
total Pathological Complete Response(tpCR)
Time frame: Up to six months.
Overall Response Rate(ORR)
Time frame: Up to 24 weeks.
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 4 Aug 2026.
- 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.
Yu Ren, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel oral solution plus Trastuzumab and Pertuzumab in people with HER2 + Breast Cancer, run by Liu Shu 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 9 inclusion and 17 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 4 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 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 Shu Liu, PhD (86- 13908516963, Drliushu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose(MTD) (time frame: Up to 24 weeks.). 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 4 Aug 2026.