Comparing Utidelone and Docetaxel for Breast Cancer Treatment

A Phase III, Open-label, Randomized, Controlled Study of Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With High-risk Early-stage or Locally Advanced HER2-negative Breast Cancer

This study is testing whether a new treatment called Utidelone combined with standard chemotherapy works better than Docetaxel for people with high-risk HER2-negative breast cancer before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 552 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, cyclophosphamide, doxorubicin
• Locations: 1 site (Shanghai)
• Trial ID: NCT05673629 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Utidelone combined with doxorubicin and cyclophosphamide (AC) versus Docetaxel combined with AC as neoadjuvant chemotherapy for patients with high-risk HER2-negative early-stage or locally advanced breast cancer. In this phase III, multi-center, open-label, randomized controlled study, 552 subjects will be enrolled and assigned to one of the two treatment groups. Each treatment cycle lasts 21 days, with a total of six cycles administered. Patients will be assessed for clinical and pathological remission following treatment and surgery, with safety evaluations conducted after the last dose and follow-up for disease recurrence lasting at least three years.

Who should consider this trial

Good fit: Ideal candidates include female patients aged 18 to 70 with pathologically confirmed HER2-negative breast cancer who meet specific tumor size and lymph node involvement criteria.

Not a fit: Patients with HER2-positive breast cancer or those who do not meet the specified eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective neoadjuvant chemotherapy option for patients with HER2-negative breast cancer.

How similar studies have performed: Other studies have shown success with similar chemotherapy approaches, but the specific combination of Utidelone and AC is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Female patients who will receive initial treatment, 18 ≤ years of age ≤70.
2. Pathologically confirmed HER2-negative breast cancer at each investigational site with IHC at 0 or 1+, or IHC at 2+ with HER2 being negative by ISH (please refer to the ASCO/CAP Guideline 2020 for the relevant definition).
3. For patients with triple negative breast cancer, the requirement is tumor size\>2 cm or lymph node-positive (T1, N1-3, M0, T2-4, any N, M0; tumor stage: II or III).
4. For patients with HR-positive and HER2-negative breast cancer, the requirement is (T2-4, N1-3, M0 or T2-4, N0 with high risk factors, M0):

   * Tumor size\>2cm
   * lymph node-positive or high-risk factor with pathologically negative lymph node. High risk factors include:

   A. histologic grade 3.

   B. high Ki67 expression (≥20%).
5. Baseline routine blood tests within 1 week prior to enrollment is normal, with CTCAE grade ≤1 (based on normal values at each site's laboratory). No rhG-CSF use and no blood transfusion/EPO etc. within 14 days prior to enrollment.

   A. White blood cell count ≥ 4.0× 109/L;

   B. Neutrophil count ≥ 1.5 × 109/L;

   C. Platelet count ≥ 100 × 109/L;

   D. Hemoglobin ≥100 g/L.
6. Blood biochemistry test result is normal within 1 week prior to enrollment, with CTCAE grade ≤1 (based on normal values at each site's laboratory).

   A. Total bilirubin ≤ upper limit of normal (ULN).

   B. AST and ALT ≤ 1.5 x ULN.

   C. alkaline phosphatase ≤ 2.5×ULN.

   D. Serum creatinine ≤ 1.5×ULN.
7. Left ventricular ejection fraction (LVEF) on cardiac ultrasound ≥55%.
8. ECOG performance status 0 or 1.
9. Females of childbearing potential must agree to use effective contraception during the study and within 6 months after the last dose. The blood or urine pregnancy test for female patients of childbearing age prior to enrollment must be negative.
10. The patient willingly participates in this study, will sign the informed consent form, and commits to following the treatment and follow-up schedule.

Exclusion Criteria:

1. Stage IV metastatic breast cancer.
2. Inflammatory breast cancer.
3. Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).
4. Patients who have previously received anti-tumor treatment or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin and squamous cell carcinoma.
5. Patients who receive any sex hormone therapy (e.g., birth control pills, hormone replacement therapy, etc.), or any hormonal drug (e.g., raloxifene, tamoxifen, or other selective estrogen receptor modulators) for osteoporosis or breast cancer prevention.
6. Patients received major surgical operation unrelated to breast cancer within 4 weeks prior to randomization or having not yet fully recovered.
7. Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥ 2.
8. Patients with severe cardiovascular diseases, including but not limited to:

   A. history of congestive heart failure or systolic dysfunction (LVEF \< 50%).

   B. angina requiring anti-anginal medication.

   C. high-risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; mean QTcF \>470ms in 3 12-lead ECGs tests at rest.

   D. clinically significant heart valve disease with impaired cardiac function.

   E. Clinically uncontrollable hypertension.

   F. History of myocardial infarction.
9. Patients allergic to any ingredient of any drug to be administered in this study.
10. Patients unsuitable for corticosteroids.
11. Patients with active infection and currently in need of systemic anti-infective therapy.
12. Patients with history of immunodeficiency, including history of HIV, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
13. Patients who have participated in another interventional drug trial within 28 days prior to randomization or are concurrently participating in another clinical trial or using another investigational treatment.
14. Patients during pregnancy (positive pregnancy test), lactation.
15. Patients with any other co-morbidities that interfere with the regimens in this study, or in the opinion of the investigator, the subject has a history of other serious systemic disease or other reasons that make participation in this trial inadvisable.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Zhimin Shao, MD — Fudan University
• Study coordinator: RONGGUO QIU, PhD

Conditions Breast Cancer