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

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

NCT ID: NCT06385990

Condition: Triple Negative Breast Neoplasms

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Capecitabine

Conditions: Keywords:
adjuvant chemotherapy
non-pCR

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: UTD1
Description: 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.
Arm group label: UTD1 in combination with capecitabine

Other name: capecitabine

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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Quchang Ouyang

Address:
City: Changsha
Zip: 410083
Country: China

Status: Recruiting

Contact:
Last name: Quchang Ouyang

Phone: 8673189762161
Email: oyqc1969@126.com

Start date: March 29, 2024

Completion date: March 29, 2027

Lead sponsor:
Agency: Hunan Cancer Hospital
Agency class: Other

Source: Hunan Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06385990