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Breast CancerPhase 2NCT06513364

Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer

A Phase 2 study testing WH002 and paclitaxel injection in people with Breast Cancer, run by Beijing Wehand-Bio Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the safety and efficacy of bi-weekly WH002(Paclitaxel Medium and Long Chain Fat Emulsion Injection,Cholesterol Bound) vs Paclitaxel both followed by bi-weekly Epirubicin and Cyclophosphamide as neoadjuvant treatment in women with HER2-negative breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
WH002 and paclitaxel injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
10 Sep 2024to 17 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, female;
  • Histologically confirmed, untreated, unilateral primary invasive breast cancer;
  • Confirmed as HER2-negative breast cancer based on pathology testing at the research center; simultaneous determination of hormone receptor status (estrogen receptor [ER] and progesterone receptor [PgR]), tumor grade, and Ki67 value;
  • Clinical staging based on imaging assessment meeting any of the following criteria: IIA (T1c, N1; T2, N0), IIB (T2, N1; T3, N0), IIIA-IIIC (T1c-2, N2-3; T3, N1-3; T4, any N);
  • Patient agrees to undergo breast cancer surgery after completing neoadjuvant chemotherapy;
  • The Eastern Cooperative Oncology Group performance status ≤1;
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  • Essentially normal function of major organs, with laboratory test values during screening conforming to the following standards:
  • System Laboratory Test Values Hematology Absolute Neutrophil Count ≥1.5×10^9/L Platelets ≥100×10^9/L Hemoglobin ≥100g/L Kidney Serum Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (CCr) ≥60 mL/min (calculated using the Cockcroft-Gault formula) Liver Total Bilirubin (serum) ≤1.5×ULN Aspartate Aminotransferase and Alanine Aminotransferase ≤2.5×ULN Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN, unless the subject is on anticoagulant therapy；
  • Echocardiographic assessment: Left Ventricular Ejection Fraction (LVEF) ≥50%;
  • For patients of childbearing potential: Patients must agree to effective contraception during the treatment period and for at least 90 days after the last dose of study treatment, adopting double-barrier contraceptive methods, such as condoms, oral or injectable contraceptives, intrauterine devices, etc.;
  • Voluntarily signs the informed consent form, demonstrating good compliance.

Who cannot join

  • Patients with stage IV metastatic breast cancer or those deemed by the investigator as ineligible for curative surgical resection following neoadjuvant therapy;
  • Inflammatory breast cancer and bilateral primary breast cancer (including invasive and in situ carcinomas).
  • Patients requiring concurrent use of medications that may affect the metabolism of the study drug within 2 weeks prior to enrollment or during the study, such as strong CYP2C8 or CYP3A4 inducers or inhibitors;
  • Breast cancer patients who have previously received anti-tumor treatments, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, or who have undergone breast surgery (excluding diagnostic biopsy for primary breast cancer);
  • Patients who must receive additional anti-tumor therapies other than the investigational product during the study, such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy regimens, or radiotherapy;
  • Patients with a history of allergic constitution (excluding mild, asymptomatic seasonal allergies), or known hypersensitivity to taxane drugs/WH002 or its excipients [e.g., allergy to medications containing polyoxyethylated castor oil (like cyclosporine); or allergy to drugs containing hardened castor oil (such as vitamin injections); or allergy to lipid emulsion-based drugs], or known allergy to epirubicin, cyclophosphamide, and/or their excipients;
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  • Patients with severe organ dysfunction (heart, lung, liver, kidney, brain, etc.), or those who have experienced severe cardiovascular events within 6 months prior to dosing, such as myocardial infarction, unstable angina, coronary artery bypass or peripheral arterial bypass graft surgery, congestive heart failure, significant cerebrovascular events (including transient ischemic attacks), or have arrhythmias requiring treatment, confirmed prolongation of QTc interval (≥470ms) upon reassessment, and chronic heart failure patients (NYHA class III and IV); poorly controlled diabetes (fasting blood glucose ≥13.3mmol/L); inadequately controlled hypertension (systolic pressure >160 mmHg or diastolic pressure >100 mmHg), etc.;
  • Patients who have had or concurrently have other malignant tumors within the past 5 years, excluding those with basal cell or squamous cell carcinoma of the skin treated with curative intent, or cervical carcinoma in situ;
  • Patients with active infections requiring intravenous antibiotic treatment;
  • Women of childbearing potential who are pregnant, breastfeeding, or have a positive pregnancy test;
  • History of motor or sensory neuropathy from any cause (greater than NCI-CTCAE V5.0 Grade 1) prior to enrollment;
  • Participation in another clinical trial within 4 weeks prior to enrollment(excluding clinical trials involving no pharmacological or medical device interventions);
  • Any condition, as judged by the investigator, that makes the subject unsuitable for participation in this clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase II Randomized Parallel Study of Comparing WH002 With Paclitaxel Both Sequential of Epirubicin and Cyclophosphamide As Neoadjuvant Treatment of Women With HER2-Negative Breast Cancer

The purpose of this study is to compare the safety and efficacy of bi-weekly WH002(Paclitaxel Medium and Long Chain Fat Emulsion Injection,Cholesterol Bound) vs Paclitaxel both followed by bi-weekly Epirubicin and Cyclophosphamide as neoadjuvant treatment in women with HER2-negative breast cancer.

Read the detailed description

This study is a multicenter, randomized, open-label, positive-drug parallel-controlled phase II trial. The primary aim of this study was to compare the safety, efficacy, and pharmacokinetics of a dose-dense regimen of bi-weekly WH002 followed by bi-weekly epirubicin and cyclophosphamide (ddWH002-ddEC) versus bi-weekly Paclitaxel® followed by bi-weekly EC (ddP-ddEC) as neoadjuvant treatment in women with HER2-negative high-risk early-stage and locally advanced breast cancer. Patients randomly assigned to ddP-ddEC received premedication with oral prednisolone (12 and 6 hours before paclitaxel), IV dexchlorpheniramine, and cimetidine or ranitidine (30 minutes before paclitaxel). Whereas all of these premedication was not required in the ddWH002-ddEC group before receiving WH002.

Eligible subjects are those with biopsy-confirmed, HER2-negative breast cancer as verified by the research center, and whose tumor staging, as determined by imaging, falls into the categories of early high-risk (T1c-2, N1; T2, N0) or locally advanced (T1c-2, N2-3; T3-4, N0-3). Upon fulfilling all inclusion and exclusion criteria, participants will be randomized in a 1:1 ratio to either the WH002 followed by EC group (Group A) or the Paclitaxel® followed by EC group (Group B).Stratified randomization between the two groups based on tumor molecular subtypes:

  • Luminal type (HER2-negative, ER or progesterone receptor positive),
  • Triple-negative (HER2-negative, ER and progesterone receptor negative).
Conditions
Breast Cancer
Being tested
WH002, paclitaxel injection
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WH002Drug

    Also called Paclitaxel Medium/Long-chain Fat Emulsion Injection (Cholesterol-Conjugated)

    Group A（ddWH002-ddEC）： Regimen for Group A during Cycles 1-Cycles 4:WH002， 260 mg/m² administered intravenously on Day 1, with a cycle length of 2 weeks (Q2W), repeated for a total of 4 cycles.

    Regimen for Group A during Cycles 5-Cycles 8:

    • Epirubicin Hydrochloride 90 mg/m² and Cyclophosphamide for Injection 600 mg/m², both administered intravenously on Day 1, with each cycle lasting 2 weeks (Q2W), continued for 4 consecutive cycles.

  • paclitaxel injectionDrug

    Also called Taxol

    Group B (ddP-ddEC):

    Regimen for Group B during Cycles C1-C4:

    • Paclitaxel Injection (Paclitaxel®) 175 mg/m², administered intravenously on Day 1, with a cycle duration of 2 weeks (Q2W), repeated for a total of 4 cycles.

    Regimen for Group B during Cycles C5-C8:

    • Epirubicin Hydrochloride 90 mg/m² and Cyclophosphamide for Injection 600 mg/m², both administered intravenously on Day 1, with cycles recurring every 2 weeks (Q2W), for a series of 4 cycles.
Study groups in NCT06513364
Study groupRoleWhat they receive
WH002ExperimentalGroup A（ddWH002-ddEC）： Regimen for Group A during Cycles 1-Cycles 4: • Paclitaxel Medium/Long-chain Fat Emulsion Injection (Cholesterol-Conjugated), 260 mg/m² administered intravenously on Day 1, with a cycle length of 2 weeks (Q2W), repeated for a total of 4 cycles. Regimen for Group A during Cycles 5-Cycles 8: • Epirubicin Hydrochloride 90 mg/m² and Cyclophosphamide for Injection 600 mg/m², both administered intravenously on Day 1, with each cycle lasting 2 weeks (Q2W), continued for 4 consecutive cycles.
Receives: Drug: WH002
Paclitaxel InjectionActive comparatorGroup B (ddP-ddEC): Regimen for Group B during Cycles C1-C4: • Paclitaxel Injection (Paclitaxel®) 175 mg/m², administered intravenously on Day 1, with a cycle duration of 2 weeks (Q2W), repeated for a total of 4 cycles. Regimen for Group B during Cycles C5-C8: • Epirubicin Hydrochloride 90 mg/m² and Cyclophosphamide for Injection 600 mg/m², both administered intravenously on Day 1, with cycles recurring every 2 weeks (Q2W), for a series of 4 cycles.
Receives: Drug: paclitaxel injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events during the treatment period.

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported.Compare the safety and tolerability between the WH002 group and the Paclitaxel® group during the treatment period. Patients will be assessed for adverse events by clinical examination, questioning for symptoms of toxicity, laboratory assessments, vital signs, ECG and LVEF.

    Neurological toxicity and other toxicities will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 5.0.

    Measured: From the first administration of the medication until 28 days after the breast cancer surgery, or 28 days after the last administration of the medication.

Secondary outcomes (10)

  1. pathologic Complete Response(pCR) Rate

    Comparison of the overall pathological complete response rate (tpCR, defined as ypT0/ypTis ypN0) between the WH002 group and the Paclitaxel® group;

    Measured: the duration of 28 days of Postoperative of Breast Cancer；

  2. pathologic Complete Response (pCR) and Breast Pathological Complete Response Rate(bpCR )

    Comparison of the rates of pCR defined as ypT0 ypN0 and bpCR (ypT0/Tis) between the WH002 group and the Paclitaxel® group;

    Measured: the duration of 28 days of Postoperative Breast Cancer；

  3. objective response rate(ORR)

    Comparison of the objective response rate (ORR) assessed by ultrasound, mammography or MRI after paclitaxel treatment and sequential EC treatment between the WH002 group and the Paclitaxel® group;

    Measured: At the end of Cycle 2 (each cycle is 14 days)； At the end of Cycle 4 (each cycle is 14 days)；At the end of Cycle6 (each cycle is 14 days)；At the end of Cycle 8 (each cycle is 14 days)；

  4. time to peak concentration (Tmax)

    Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: the 1th day and 2th day of cycle 1 (each cycle is 14 days)，the 1th day and 2th day of cycle 4 (each cycle is 14 days)；

  5. peak concentration (Cmax)

    Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: cycle 1（14 days）and cycle 4（14 days）；

  6. AUC0-inf

    area under the concentration-time curve from time zero to the infinity. Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: cycle 1（14 days）and cycle 4（14 days）；

  7. AUC0-t

    area under the concentration-time curve from time zero to the last measurable .Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: cycle 1（14 days）and cycle 4（14 days）；

  8. half-life (t½)

    Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: cycle 1（14 days）and cycle 4（14 days）；

  9. clearance (CL)

    Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: cycle 1（14 days）and cycle 4（14 days）；

  10. free fraction

    ratio of free paclitaxel concentration to total paclitaxel concentration. Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration.

    Measured: cycle 1（14 days）and cycle 4（14 days）；

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start10 Sep 2024
  3. Primary completion15 Aug 2025
  4. Study completion17 Nov 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06513364
Sponsor's protocol ID
WH002-I-102
Status last verified
Jun 2026
First submitted
8 Jul 2024
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing WH002 and paclitaxel injection in people with Breast Cancer, run by Beijing Wehand-Bio Pharmaceutical Co., Ltd 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 11 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: finished, as of the sponsor's last update on 9 Jun 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events during the treatment period. (time frame: From the first administration of the medication until 28 days after the breast cancer surgery, or 28 days after the last administration of the medication.). 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 NCT06513364.

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 9 Jun 2026.

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