Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer

NCT05983094 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC4047
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone based regimen as neoadjuvant treatment With High-risk Early-stage or Locally Advanced Breast Cancer.

Conditions

Breast Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (etpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is, (yp)N0)

  Percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and breast

  24 months

Secondary Outcomes (5)

• Breast Pathologic Complete Response ((bpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is)

  24 months

• Event Free Survival(EFS) of 2 years

  24 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Through study completion，an average of 1 year

• Patient reported outcome (PRO)

  Through study completion，an average of 1 year

• Patient reported outcome (PRO)

  Through study completion，an average of 1 year

Study Arms (3)

cohort 1 Triple-negative breast cancer

EXPERIMENTAL

Hormone Receptor(HR) negative, Human Epidermal Growth Factor Receptor 2(HER2 )negative breast cancer Drug: Utidelone in combination with carboplatin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin ,Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total.

Drug: Utidelone; Drug: Carboplatin

cohort 2 HR positive, HER2 negative breast cancer

EXPERIMENTAL

HR positive, HER2 negative, Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH)non-amplification breast cancer Drug: Utidelone in combination with Epirubicin Utidelone injection 30mg/m2, on days 1-5 of each cycle; Epirubicin 75mg/m2 was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total.

Drug: Utidelone; Drug: Epirubicin

cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer

EXPERIMENTAL

Drug: Utidelone in combination with carboplatin, trastuzumab and pertuzumab Utidelone injection 30mg/m2, on days 1-5 of each cycle; Carboplatin Area Under Curve(AUC)6, iv, was administered on day 1; One treatment cycle is 21 days, and there are 6 cycles in total. Trastuzumab 8mg/kg iv in first cycle on day 1, then 8mg/kg in the rest cycles; pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles. One treatment cycle is 21 days, and there are 6 cycles in total.

Drug: Utidelone; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab

Interventions

Utidelone DRUG

Utidelone injection 30mg/m2, on days 1-5 of each cycle

cohort 1 Triple-negative breast cancer; cohort 2 HR positive, HER2 negative breast cancer; cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer

Carboplatin DRUG

Carboplatin Area under curve(AUC)6, iv, was administered on day 1

cohort 1 Triple-negative breast cancer; cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer

Epirubicin DRUG

Epirubicin 75mg/m2 was administered on day 1

cohort 2 HR positive, HER2 negative breast cancer

Trastuzumab DRUG

Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles

cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer

Pertuzumab DRUG

Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles

cohort 3 HER2 positive (IHC 3+; IHC 2+,FISH amplification) breast cancer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients who will receive initial treatment, 18-70 years of age；
• Newly diagnosed high-risk early stage (T1c-2, N1; T2, N0) and locally advanced (T1c-2, N2-3; T3-4, N0-3) breast cancer (tumor stage II, III), in which HR+/HER2- T2, N0 patients need to be accompanied by high-risk factors (histological grade 3 or Ki67 ≥ 20%). Triple negative breast cancer(TNBC), HER2 positive (Immunohistochemical(IHC)3+; IHC 2+, FISH amplification) breast cancer, HR negative HER2 IHC 2+ and undetermined result of FISH, HR positive HER2 negative (IHC 0,1+; 2+, FISH amplification) breast cancer confirmed by pathological test.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1
• The blood routine examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory). No Human Granulocyte Colony Stimulating Factor(rhGCSF) or blood transfusion/erythropoietin(EPO) or other drugs were used within 14 days prior to enrollment.
• White blood cell count (WBC) ≥ 4 x109 / L; Neutrophil count (ANC) \> 1.5x109 / L; Platelet count (PLT) ≥ 100×109/L Hemoglobin(Hb) ≥ 100g/L.
• The blood biochemistry examination was basically normal (CTCAE ≤ 1) within one week before enrollment (based on the normal values of each research center laboratory) Serum total bilirubin ≤ Upper limit of normal value(ULN)； Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 1.5×ULN； Alkaline phosphatase ≤ 2.5×ULN； Serum creatinine ≤ 1.5×ULN.
• Color Doppler echocardiography left ventricular Ejection fraction (LVEF) ≥ 55%
• Female patients with fertility must agree to use effective contraceptive methods during the study period and within 6 months of the last study medication. The Pregnancy test (urine or serum) must be negative
• Be willing and able to provide written informed consent/assent for the trial.

You may not qualify if:

• Primary stage IV breast cancer；
• Inflammatory breast cancer;
• Bilateral primary breast cancer (including invasive cancer and carcinoma in situ)；
• Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell carcinoma.
• Receive any sex hormone treatment (such as contraceptives, ovarian hormone replacement therapy, etc.), except for Ovarian function suppression（OFS）fertility protection, or any hormone drugs (such as Raloxifene, tamoxifen, or other selective estrogen receptor modulators) to treat osteoporosis or prevent breast cancer；
• The patient has undergone major surgery unrelated to breast cancer within 4 weeks before treatment or has not yet fully recovered;
• Symptomatic peripheral neuropathy CTCAE 5.0 grade ≥ 2
• Serious cardio cerebral Vascular disease, including but not limited to the followings:
• History of congestive heart failure or systolic dysfunction (LVEF\<50%);
• Angina pectoris requiring anti angina drugs;
• High risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, II-III degree atrioventricular block, etc; Under resting state, the average corrected Q-T interval(QTcF) of three 12 lead electrocardiogram examinations is\>470ms;
• Clinically significant heart valve disease with cardiac dysfunction;
• Hypertension that cannot be controlled;
• History of myocardial infarction
• Allergic to any component of any drug in this protocol.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Chinese Academy of Medical Sciences: collaborator
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator
• First Affiliated Hospital of China Medical University: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Epirubicin; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Medical Oncology

Model Details: Study of Utidelone based neoadjuvant treatment on early high-risk or locally advanced breast cancer

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 9, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

CN (1)