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

NCT05172518 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2021-12-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chengdu Biostar Pharmaceuticals

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2027-03-01
Completion
2030-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172518 on ClinicalTrials.gov