NCT05172518

Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer

Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open-label, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 512 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a phase III trial to explore the efficacy and safety of utidelone plus capecitabine versus taxane plus capecitabine in HER2-negative locally advanced or metastatic breast cancer and the differences of metronomic capecitabine and intermittent capecitabine in combination chemotherapy.

Conditions

• Breast Neoplasms
• Locally Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Taxane plus Intermittent Capecitabine	Eligible patients will receive treatment with taxane (paclitaxel, nab-paclitaxel or docetaxel , the dosage reference to related prescribing information or clinical practice by investigators) plus capecitabine (1000 mg/ m2 twice daily D1-14 Q3W) for 6 \~8 cycles(for the the patients with SD, PR or CR after 6\~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy ), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
DRUG	Utidelone plus Intermittent Capecitabine	Eligible patients will receive treatment with utidelone (30 mg/ m2 /day D1-5 Q3W) plus capecitabine (1000 mg/ m2 twice daily D1-14 Q3W) for 6 \~8 cycles(for the the patients with SD, PR or CR after 6\~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
DRUG	Taxane plus Metronomic Capecitabine	Eligible patients will receive treatment with taxane (paclitaxel, nab-paclitaxel or docetaxel , the dosage reference to related prescribing information or clinical practice by investigators) plus capecitabine ( 500 mg three times daily on days 1-21 Q3W) for 6 \~8 cycles(For the the patients with SD, PR or CR after 6\~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
DRUG	Utidelone plus Metronomic Capecitabine	Eligible patients will receive treatment with utidelone (30 mg/ m2 /day D1-5 Q3W) plus capecitabine (500 mg three times daily on days 1-21 Q3W) for 6 \~8 cycles(for the the patients with SD, PR or CR after 6\~8 cycles treatment could choose to receive continuous combination therapy or capecitabine maintenance mono therapy ), or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

Timeline

• Start date: 2022-03-01
• Primary completion: 2027-03-01
• Completion: 2030-03-01
• First posted: 2021-12-29
• Last updated: 2021-12-29

Locations

1 site across 1 country: China