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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05983094
• Other study ID #: NCC4047
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: August 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single arm, multi-center study,three-cohort, prospective phase II study which will enroll 181 high-risk early-stage or locally advanced breast cancer patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 181
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female patients who will receive initial treatment, 18-70 years of age;

2. 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.

3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1

4. 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.

5. 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.

6. Color Doppler echocardiography left ventricular Ejection fraction (LVEF) = 55%

7. 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

8. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

1. Primary stage IV breast cancer;

2. Inflammatory breast cancer;

3. Bilateral primary breast cancer (including invasive cancer and carcinoma in situ);

4. Previous anti-cancer treatment or radiotherapy for any malignant tumor, excluding cured cervical Carcinoma in situ, skin Basal-cell carcinoma and squamous cell carcinoma.

5. 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;

6. The patient has undergone major surgery unrelated to breast cancer within 4 weeks before treatment or has not yet fully recovered;

7. Symptomatic peripheral neuropathy CTCAE 5.0 grade = 2

8. Serious cardio cerebral Vascular disease, including but not limited to the followings:

9. History of congestive heart failure or systolic dysfunction (LVEF<50%);

10. Angina pectoris requiring anti angina drugs;

11. 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;

12. Clinically significant heart valve disease with cardiac dysfunction;

13. Hypertension that cannot be controlled;

14. History of myocardial infarction

15. Allergic to any component of any drug in this protocol.

16. Those who are not suitable for using Corticosteroid.

17. Individuals with active infections who currently require systematic anti infection treatment.

18. History of immune deficiency disease, including positive of HIV/AIDS, or other acquired or congenital immune deficiency diseases, or having a history of organ transplantation.

19. Who had participated in other drug intervention clinical trials within the 28 days of randomization, or who is participating in another clinical trial or is using other investigational treatments.

20. Individuals in pregnancy (positive Pregnancy test) and lactation.

21. Any other comorbidities that interfere with the implementation of the treatment plan, or the researcher evaluate that the subject has a history of other serious systemic diseases, or other reasons lead to the patients is unsuitable to participate in this trial.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoadjuvant Therapy

Intervention

Drug:
• Utidelone
Utidelone injection 30mg/m2, on days 1-5 of each cycle
• Carboplatin
Carboplatin Area under curve(AUC)6, iv, was administered on day 1
• Epirubicin
Epirubicin 75mg/m2 was administered on day 1
• Trastuzumab
Trastuzumab 8mg/kg iv in first cycle on day 1, then 6mg/kg in the rest cycles
• Pertuzumab
Pertuzumab 840mg/kg iv in first cycle on day 1, then 420mg/kg in the rest cycles

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Chinese Academy of Medical Sciences Cancer Hospital,Shanxi Center, Chinese Academy of Medical Sciences Cancer Hospital,Shenzhen Center, First Affiliated Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breast Pathologic Complete Response ((bpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is)	Percentage of patients whose pathological evaluation of hematoxylin and eosin-stained breast samples do not show any residual invasive carcinoma	24 months
Secondary	Event Free Survival(EFS) of 2 years	Time from the first dose of study intervention administration to any of the following events: progression of disease that precludes surgery, local or distant recurrence after surgery, second primary malignancy (breast or other invasive cancers), or death due to any cause.	24 months
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Graded according to the Common Terminology Criteria for Adverse Event (CTCAE) grade and changes in CTCAE grade	Through study completion,an average of 1 year
Secondary	Patient reported outcome (PRO)	National Cancer Center of China-Breast Cancer-A 1.0 (NCC-BC-A 1.0) during the study was used to assess the quality of life;The minimum to maximum values: 0 , 100 Meaning: the higher scores mean a better outcome.	Through study completion,an average of 1 year
Secondary	Patient reported outcome (PRO)	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-chemotherapy-induced peripheral neuropathy(CIPN) twenty-item scale (QLQ-CIPN20) was used to assess the quality of life.	Through study completion,an average of 1 year