Breast NeoplasmsPhase 3NCT05430399
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
A Phase 3 study testing utidelone and docetaxel in people with Breast Neoplasms and Locally Advanced or Metastatic Breast Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- utidelone and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 2 sitesChina
- Study dates
- 21 Jun 2022to 1 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shusen Wang
Guangzhou, Gangdong
shusen wang, MD, +86-020-87342693, wangshs@sysucc.org.cn
- Not yet recruiting
Hunan Cancer Hospital
Hunan, Hunan, 410000
Quchang OuYang, MD, oyqc1969@126.com
About this study
Official title: 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.
- Being tested
- utidelone, docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
utideloneDrug
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.
docetaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | utidelone Receives: Drug: utidelone |
| Arm B | Active comparator | docetaxel Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from randomization to progression or death (whichever occurred first)
Measured: up to 60 months
Secondary outcomes (5)
Objective response rate (ORR)
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria
Measured: up to 60 months
Time to response (TTR)
the time from randomization to the first documentation of disease response (CR or PR)
Measured: up to 60 months
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.
Measured: up to 60 months
Overall survival (OS)
Time from randomization to death Time from randomization to death Time from randomization to death Time from randomization to death
Measured: up to 60 months
Patient-reported health-related quality of life (QoL): FACT-B total score
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.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start21 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Biostar Pharmaceuticals Co., Ltd., Hunan Cancer Hospital
- Responsible party
- Principal investigator, wang shusen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430399
- Sponsor's protocol ID
- SYSU-2022-UCAN
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05430399
- Acronym / sponsor ID
- SYSU-2022-UCAN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 349 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Beijing Biostar Pharmaceuticals Co., Ltd., Hunan Cancer Hospital
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: utideloneutidelone |
| Arm B | Active comparator | Drug: docetaxeldocetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| utideloneEligible 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. | Drug | Arm A |
| docetaxelEligible 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. | Drug | Arm B |
Primary outcome
Progression Free Survival (PFS)
Time frame: up to 60 months
Time from randomization to progression or death (whichever occurred first)
5 secondary outcomes
Objective response rate (ORR)
Time frame: up to 60 months
Time to response (TTR)
Time frame: up to 60 months
Duration of response (DOR)
Time frame: up to 60 months
Overall survival (OS)
Time frame: up to 60 months
Patient-reported health-related quality of life (QoL): FACT-B total score
Time frame: up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing utidelone and docetaxel in people with Breast Neoplasms and Locally Advanced or Metastatic Breast Cancer, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shusen wang, MD (+86-020-87342693, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.