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.
Signed Informed Consent Form;
Women aged ≥ 18 years;
Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;
The primary tumor and metastases (if aspirated) are both HER2-negative;
HER-2 positive (IHC + + +, or FISH positive);
Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;
Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;
Factorial
Taxane plus Intermittent Capecitabine
DrugEligible 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.
Utidelone plus Intermittent Capecitabine
DrugEligible 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.
Taxane plus Metronomic Capecitabine
DrugEligible 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.
Utidelone plus Metronomic Capecitabine
DrugEligible 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.
Progression Free Survival (PFS)
Time from randomization to progression or death (whichever occurred first).
Objective response rate (ORR)
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria.
Time to response (TTR)
the time from randomization to the first documentation of disease response (CR or PR).
Duration of response (DOR)
the time from the first evaluation that criteria for CR or PR are met until PD or death is observed, whichever occurs first, calculated only for patients whose best response is evaluated as CR or PR.
Overall survival (OS)
Time from randomization to death Time from randomization to death Time from randomization to death Time from randomization to death.
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Sun Yat-sen University
Lead sponsor
Chengdu Biostar Pharmaceuticals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
