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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

512

Participants

Timeline

Start Date

March 1, 2022

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2030

Conditions
Breast NeoplasmsLocally Advanced or Metastatic Breast Cancer
Interventions
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.

Trial Locations (1)

510060

Shusen Wang, Guangzhou

Sponsors
All Listed Sponsors
collaborator

Chengdu Biostar Pharmaceuticals

INDUSTRY

lead

Sun Yat-sen University

OTHER