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

NCT ID: NCT05172518

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2030-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Taxane plus Intermittent Capecitabine

Group Type: ACTIVE_COMPARATOR

Taxane plus Intermittent Capecitabine

Intervention Type: DRUG

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.

Arm B

Utidelone plus Intermittent Capecitabine

Group Type: EXPERIMENTAL

Utidelone plus Intermittent Capecitabine

Intervention Type: DRUG

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.

Arm C

Taxane plus Metronomic Capecitabine

Group Type: ACTIVE_COMPARATOR

Taxane plus Metronomic Capecitabine

Intervention Type: DRUG

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.

Arm D

Utidelone plus Metronomic Capecitabine

Group Type: EXPERIMENTAL

Utidelone plus Metronomic Capecitabine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;
• Eastern Cooperative Oncology Group (ECOG) score [0-2] points;
• Measurable disease according to RECIST version 1.1;
• Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomisation;
• No more than one prior chemotherapy regimen for inoperable locally advanced or metastatic HER2-negative breast cancer;
• Hormone receptor positive patients are allowed no more than two lines of prior endocrine therapy for metastatic disease (including CDK4/6 inhibitors, chidamide and PI3K inhibitors, etc.);
• Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior antineoplastic therapy. However, patients with any grade of alopecia are allowed ;
• Patients with asymptomatic CNS metastases may be enrolled, if:

1. Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or

2. Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;

• Adequate hematological, hepatic and renal function;
• Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 90 days after the last dose of experiment treatment;
• Life expectancy of at least 12 weeks;
• Patients must be able to participate and comply with treatment and follow-up.

Exclusion Criteria

• 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;
• Symptomatic peripheral neuropathy or CTCAE 5.0 grade ≥ 2;
• Experienced grade 3 or above nervous system-related adverse events after treatment with anti-microtubule drugs;
• Received taxane and/or capecitabine-containing adjuvant/neoadjuvant chemotherapy within 1 year prior to the first study treatment;
• Received prior first-line chemotherapy containing a taxane or capecitabine;
• Symptomatic central nervous system metastases;
• Inability to take or absorb oral medications;
• Pregnant or lactating women;
• Known or suspected hypersensitivity to any of the study drugs or excipients;
• Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that precludes study treatment implementation or follow-up ；
• Any other condition that the investigator considers inappropriate to participate in this trial .
• Use of corticosteroids is prohibited.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Biostar Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

wang shusen

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shusen Wang

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Shusen Wang, MD

Role: CONTACT

Phone: +86-13926168469

Email: wangshs@sysucc.org.cn

Other Identifiers

SYSU-2021-UCAN

Identifier Type: -

Identifier Source: org_study_id