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

NCT ID: NCT06385990

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-29
• Study Completion Date: 2027-03-29

Brief 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.

Conditions

Triple Negative Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UTD1 in combination with capecitabine

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.

Group Type: EXPERIMENTAL

UTD1

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

capecitabine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quchang Ouyang

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Quchang Ouyang

Role: CONTACT

oyqc1969@126.com

8673189762161

Facility Contacts

Quchang Ouyang

Role: primary

oyqc1969@126.com

8673189762161

Other Identifiers

2024ks01

Identifier Type: -

Identifier Source: org_study_id