- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430399
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
July 11, 2023 updated by: wang shusen, Sun Yat-sen University
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial
It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
349
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: shusen wang, MD
- Phone Number: +86-020-87342693
- Email: wangshs@sysucc.org.cn
Study Locations
-
-
Gangdong
-
Guangzhou, Gangdong, China
- Recruiting
- Shusen Wang
-
Contact:
- shusen wang, MD
- Phone Number: +86-020-87342693
- Email: wangshs@sysucc.org.cn
-
-
Hunan
-
Hunan, Hunan, China, 410000
- Not yet recruiting
- Hunan Cancer Hospital
-
Contact:
- Quchang OuYang, MD
- Email: oyqc1969@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed the 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 re-biopsy was performed) were both HER2-negative;
- Eastern Cooperative Oncology Group (ECOG) score [0-1] points;
- Patients must have metastatic disease that is evaluable on imaging: including at least one measurable lesion (assessed according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)); or only non-measurable disease as defined by RECIST 1.1 , especially in patients with bone metastases only, while the disease could be documented/assessed by bone scan, PET or MRI;
- Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomization;
- No previous chemotherapy for advanced breast cancer ;
- For HR+ breast cancer patients shall meet one of the two criteria below: a) radiographically confirmed recurrence or progression within 2 years of adjuvant endocrine therapy; b) received at least one line of endocrine therapy in the recurrence or metastasis stage;
- 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 were allowed ;
Patients with asymptomatic CNS metastases may be enrolled, if:
- Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or
- Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;
- Adequate hematological, hepatic and renal function;
- Women of childbearing 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 3+, 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, 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;
- Experienced grade ≥ 3 nervous system-related adverse events after treatment with anti-microtubule drugs;
- Symptomatic central nervous system metastases;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
utidelone
|
Eligible patients will receive treatment with utidelone(40 mg/ m2 /day, D1-5,Q3W) , treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first.
Each cycle is 3 weeks in duration.
|
Active Comparator: Arm B
docetaxel
|
Eligible patients will receive treatment with docetaxel (75mg/ m2/day, D1, Q3W) , treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first.
Each cycle is 3 weeks in duration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: up to 60 months
|
Time from randomization to progression or death (whichever occurred first)
|
up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response (DOR)
Time Frame: up to 60 months
|
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.
|
up to 60 months
|
Objective response rate (ORR)
Time Frame: up to 60 months
|
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria
|
up to 60 months
|
Time to response (TTR)
Time Frame: up to 60 months
|
the time from randomization to the first documentation of disease response (CR or PR)
|
up to 60 months
|
Overall survival (OS)
Time Frame: up to 60 months
|
Time from randomization to death Time from randomization to death Time from randomization to death Time from randomization to death
|
up to 60 months
|
Patient-reported health-related quality of life (QoL): FACT-B total score
Time Frame: up to 60 months
|
Change from baseline in the FACT-B total score for all questionnaire timepoints.
To calculate FACT-B total score patient ratings from 0 (not at all) - 4 (very much) to each of the 37 questionnaire statement are summed up.
Total score range: 0 - 148.
Higher values indicate better quality of life.
|
up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2022
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
June 2, 2022
First Submitted That Met QC Criteria
June 21, 2022
First Posted (Actual)
June 24, 2022
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 11, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSU-2022-UCAN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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