Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer

NCT05673629 | Unknown Phase 3

• 1 other identifier: BG01-2102
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in 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 randomly assigned in a 1:1 ratio to either the Utidelone plus AC group or the docetaxel plus AC group, stratified by hormone receptor status (ER and/or PgR positive vs ER and PgR negative).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Total Pathologic Complete Response

  tpCR (ypT0/is, ypN0), percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and the breast

  24 months

Secondary Outcomes (3)

• Breast Pathologic Complete Response

  24 months

• Objective Response Rate

  24 months

• 3-year Event Free Survival

  36 months

Study Arms (2)

The treatment group-Utidelone in combination with AC

EXPERIMENTAL

Utidelone Injection at 30 mg/m2/d administered on days 1-5 of each cycle. Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2 administered once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in total.

Drug: Utidelone Injection in combination with AC

The control group-Docetaxel in combination with AC

ACTIVE COMPARATOR

Docetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total.

Drug: Docetaxel Injection in combination with AC

Interventions

Utidelone Injection in combination with AC DRUG

The treatment group will be treated with Utidelone Injection at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2, administered intravenously respectively once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in total. After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site. Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence.

The treatment group-Utidelone in combination with AC

Docetaxel Injection in combination with AC DRUG

The control group will be treated with Docetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total. After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site. Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence.

The control group-Docetaxel in combination with AC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female patients who will receive initial treatment, 18 ≤years of age ≤70.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients who will receive initial treatment, 18 ≤ years of age ≤70.
• 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).
• 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).
• 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%).
• 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.
• 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).

You may not qualify if:

• Stage IV metastatic breast cancer.
• Inflammatory breast cancer.
• Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).
• 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.
• 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.
• Patients received major surgical operation unrelated to breast cancer within 4 weeks prior to randomization or having not yet fully recovered.
• Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥ 2.
• 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.
• Patients allergic to any ingredient of any drug to be administered in this study.

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Zhimin Shao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RONGGUO QIU, PhD

CONTACT

01186-56315388; rqiu2001@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: May 30, 2023
• Primary Completion: June 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 8, 2023

Record last verified: 2022-12

Locations

CN (1)