RecruitingPhase 2NCT06385990

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

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


Sponsor

Hunan Cancer Hospital

Enrollment

53 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — utidelone (UTD1) and capecitabine — as follow-up treatment for women with triple-negative breast cancer (TNBC) who did not have a complete response to chemotherapy before surgery. **You may be eligible if...** - You are a female aged 18 or older - You have confirmed triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) - You completed full neoadjuvant chemotherapy (including anthracyclines and/or taxanes) but still had cancer remaining after surgery - You are in generally good health (ECOG 0–1) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (metastatic) - You have had another cancer in the past 5 years (with some exceptions) - You have significant heart disease, active autoimmune disease, or active infections - You are pregnant or breastfeeding - You previously received capecitabine or utidelone before your surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUTD1

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(1)

Quchang Ouyang

Changsha, Hunan, China

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NCT06385990


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