Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy

Triple Negative Breast Neoplasms Clinical Trial

Official title:

Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385990
• Other study ID #: 2024ks01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 29, 2024
• Est. completion date: March 29, 2027

Study information

• Verified date: April 2024
• Source: Hunan Cancer Hospital
• Contact: Quchang Ouyang
• Phone: 8673189762161
• Email: oyqc1969[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.

Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: March 29, 2027
• Est. primary completion date: March 29, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Signed informed consent;

• 18 Years and older;

• Female;

• Breast cancer confirmed by pathological histology, ER-negative (<1% positive), PR-negative (<1% positive), and HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification;

• Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologically confirmed residual lesion, maximum diameter of 1cm) or / lymph node positive (ypN+);

• Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.

• Patients who clinically require radiotherapy of the affected breast or chest wall and regional lymph node area should receive radiotherapy before or after study medication;

• All toxicities related to previous antitumor therapy must return to Grade 1 (CTCAE v5.0), except alopecia;

• Within 1 week before enrollment, the blood routine examination was basically normal (taking the normal value of each study center as the standard): 1) Blood routine: hemoglobin (Hb) > 90g / L, White blood cell count (WBC) > 3.5*10^9 / L, Number of neutrophils (ANC) * 1.5*10^9 / L, Platelet count (PLT)* 100*10^9 / L; 2) Renal function: upper limit of normal serum creatinine value; 3) Liver function: for patients without liver metastasis: glutamulate aminotransferase (AST), glutamate aminotransferase (ALT), alkaline phosphatase (ALP) are less than 2.5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value; for patients with liver metastasis, AST, ALT, ALP, ALT, ALP, are less than 5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value;

• The ECOG physical status score for patients must be 0 or 1;

Exclusion Criteria:

• Metastatic breast cancer at diagnosis;

• Breast cancer patients who did not completed surgery;

• History of other malignancies within 5 years prior to randomization, but patients with the following tumors may participate in the study: carcinoma of the cervix in situ, colon in situ, melanoma in situ and basal cell carcinoma of the skin and squamous cell carcinoma;

• Any other non-malignant systemic disease (cardiovascular, renal, liver, etc.) that hinders the implementation or follow-up of the treatment program;

• Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or corrected QTc> 500ms at screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;

• History of interstitial pneumonia, Need for steroids or evidence of active pneumonia;

• Suffering from an active autoimmune disease, and required systemic treatment in the past 2 years (i. e., use of disease regulators, corticosteroids, or immunosuppressive drugs);

• Patients with a known infection with human immunodeficiency virus (HIV);

• Patients with active infections requiring systemic treatment;

• Any hormonal medication (such as raloxifene, tamoxifen, or other selective oestrogen receptor modulators) for osteoporosis or breast cancer prophylaxis (only patients who have discontinued these drugs before randomization may participate in the study);

• The patient received either capecitabine or utiderone before surgery;

• Pregnant or lactating women;

• Known or suspected allergy to any study drug or excipients;

• Prohibition of corticosteroids;

• Any other condition the investigator considers inappropriate to participate in the trial.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• UTD1
UTD1: 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.

Locations

Country	Name	City	State
China	Quchang Ouyang	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year disease-free survival (DFS)	2-year DFS will be defined as the percentage of patients alive without recurrence or metastasis of disease at 2 years measured from the date of enrollment.	2 years
Secondary	Overall Survival (OS)	OS was calculated for each patient based on time of enrollment to time of death.	Up to 2 years (from date of enrollment to the date of death).
Secondary	Disease Free Survival (DFS)	DFS was measured from surgery to the time of recurrence or metastasis.	Up to 2 years (from date of surgery to the date of recurrence / metastasis).
Secondary	Invasive Disease free survival (iDFS)	iDFS was measured from surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first).	From the date of surgery to the time of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first)., up to 2 years.
Secondary	Distant Disease-free Survival (DDFS)	DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.	From the date of surgery to distant recurrence, or death due to any cause (up to 2 years).