Combination of UTD1 and capecitabine for treating triple negative breast cancer

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

This study is testing if combining UTD1 with capecitabine can help people with triple negative breast cancer who didn't fully respond to earlier treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Hunan Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06385990 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of UTD1 in combination with capecitabine for patients with triple negative breast cancer (TNBC) who did not achieve a pathologic complete response after neoadjuvant therapy. It is a multicenter, single-arm trial where eligible participants receive UTD1 and capecitabine over a treatment cycle of 21 days for 6-8 cycles. The study aims to provide an adjuvant treatment option for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with confirmed triple negative breast cancer who did not achieve pathologic complete remission after neoadjuvant chemotherapy.

Not a fit: Patients who have achieved pathologic complete remission or those with HER2-positive breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for TNBC patients who have not responded fully to initial chemotherapy.

How similar studies have performed: Other studies have explored similar combinations in TNBC, but this specific approach with UTD1 is novel.

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.

Where this trial is running

Changsha, Hunan

• Quchang Ouyang — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Quchang Ouyang

Conditions Triple Negative Breast Neoplasms; adjuvant chemotherapy; non-pCR