Breast NeoplasmsPhase 2NCT05403333
Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing utidelone in people with Breast Neoplasms and Locally Advanced or Metastatic Breast Cancer, run by Fudan University.
Trial summary
This is a phase II trial to explore the efficacy and safety of weekly utidelone in HER2-negative inoperable 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2022to 9 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Informed Consent Form;
- Women aged ≥ 18 years;
- Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:
- The most recent pathology confirmed HER2 negative, defined as HER2 0/1 + by standard immunohistochemical staining (IHC) or HER2 2 + by IHC but negative by in situ hybridization (ISH);
- Patients with locally advanced or locally recurrent disease should be unable to undergo radical surgical resection confirmed by the investigators;
- Eastern Cooperative Oncology Group (ECOG) score [0-2] points;
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- At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1):
- If there is only bone metastasis, it is required that the bone metastasis lesion contains bone destruction component;
- if there is only pleural effusion, it is required that the pleural effusion is malignant confirmed by pathology
- No more than 2 prior lines of chemotherapy for advanced and/or metastatic disease;
- Prior chemotherapy regimens must have included taxane;
- Patients with hormone receptor positive disease received at least one line of endocrine therapy for metastatic disease (including CDK4/6 inhibitors, everolimus, chidamide and PI3K inhibitors, etc.);
- Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior anticancer therapy. with the following exceptions: 1). alopecia; 2). pigmentation;
- Adequate hematological, hepatic and renal function;
- Life expectancy of at least 12 weeks;
- Patients must be able to participate and comply with treatment and follow-up.
Who cannot join
- Previous treatment with UTD-1;
- Patients with other malignant tumors within 5 years prior to enrollment, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
- Anti-tumor therapy, including chemotherapy, radical radiotherapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy within 4 weeks prior to the start of study treatment; endocrine therapy within 2 weeks prior to the start of study treatment;
- Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks prior to study treatment, or need to undergo elective surgery during the trial;
- Patients with clinically suspected brain metastases. However, patients who have received previous treatment for central nervous system metastasis (radiotherapy or surgery) can be included if they have been confirmed as stable by imaging for at least 4 weeks and have stopped symptomatic treatment (including hormone and mannitol, etc.) for more than 2 weeks;
- Patients with active HBV, HCV and HIV infection; except patients with stable hepatitis B after drug treatment (DNA titer should not be higher than 500 IU/mL or copy number < 1000 copies/ml) and patients with cured hepatitis C (HCV RNA test negative);
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- Peripheral neuropathy ≥grade 2 (CTCAE 5.0) and patients with grade 1 peripheral neuropathy will be enrolled at the discretion of the investigator;
- Prior grade 3 or above nervous system-related adverse events caused by previous use of anti-microtubule drugs;
- Pregnant or lactating female patients or fertile women with positive baseline pregnancy test; or subjects of childbearing potential who are unwilling to take effective contraceptive measures during the study period and within at least 90 days after the last dose;
- Known or suspected hypersensitivity to any of the study drugs or excipients;
- Exclusion of any other non-malignant systemic diseases (cardiovascular, renal, hepatic, etc.) that preclude the implementation or follow-up of the treatment regimen; • Any other condition that the investigator considers inappropriate for participation in this trial.
About this study
This is a phase II trial to explore the efficacy and safety of weekly utidelone in HER2-negative inoperable locally advanced or metastatic breast cancer.
- Being tested
- utidelone
- 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
Also called Singel arm
Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Utidelone | Experimental | Drug: utidelone Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days Receives: Drug: utidelone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS is defined as the duration from enrollment to the first radiologically confirmed progressive disease (PD) (RECIST 1.1 criteria) or death due to any cause.
Measured: Estimated 12 months
Secondary outcomes (4)
Objective response rate (ORR)
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria
Measured: Estimated 12 months
Overall Survival (OS)
From enrollment to death (for any reason)
Measured: Estimated 24 months
Duration of Response (DOR)
The first evaluation of CR or PR to progression or death (for any reason)
Measured: Estimated 12 months
Overall summary of adverse events following intravenous administration of utidelone (safety analysis set)
Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0[ Time Frame: 1 years] Observe and record incidence of adverse events and severe adverse events associated with utidelone treatment, assessed by investigators according to CTCAE version 5.0.
Measured: Estimated 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start10 Jun 2022 (estimated)
- Primary completion9 Mar 2023 (estimated)
- Study completion9 Mar 2025 (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 Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403333
- Sponsor's protocol ID
- DOUBLE
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05403333
- Acronym / sponsor ID
- DOUBLE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 9 Mar 2023 (estimated)
- Study completion
- 9 Mar 2025 (estimated)
- First posted
- 3 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.
This is a phase II trial to explore the efficacy and safety of weekly utidelone in HER2-negative inoperable locally advanced or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utidelone | Experimental | Drug: utideloneDrug: utidelone Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed Informed Consent Form;
- Women aged ≥ 18 years;
- Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:
- Eastern Cooperative Oncology Group (ECOG) score [0-2] points;
- At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1):
Key exclusion criteria (11 listed)
- Previous treatment with UTD-1;
- Patients with other malignant tumors within 5 years prior to enrollment, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
- Anti-tumor therapy, including chemotherapy, radical radiotherapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy within 4 weeks prior to the start of study treatment; endocrine therapy within 2 weeks prior to the start of study treatment;
- Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks prior to study treatment, or need to undergo elective surgery during the trial;
- Patients with clinically suspected brain metastases. However, patients who have received previous treatment for central nervous system metastasis (radiotherapy or surgery) can be included if they have been confirmed as stable by imaging for at least 4 weeks and have stopped symptomatic treatment (including hormone and mannitol, etc.) for more than 2 weeks;
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 |
|---|---|---|
| utideloneAlso: Singel armUtidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days | Drug | Utidelone |
Primary outcome
Progression free survival (PFS)
Time frame: Estimated 12 months
PFS is defined as the duration from enrollment to the first radiologically confirmed progressive disease (PD) (RECIST 1.1 criteria) or death due to any cause.
4 secondary outcomes
Objective response rate (ORR)
Time frame: Estimated 12 months
Overall Survival (OS)
Time frame: Estimated 24 months
Duration of Response (DOR)
Time frame: Estimated 12 months
Overall summary of adverse events following intravenous administration of utidelone (safety analysis set)
Time frame: Estimated 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing utidelone in people with Breast Neoplasms and Locally Advanced or Metastatic Breast Cancer, run by Fudan University.
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 16 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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Estimated 12 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 3 Jun 2022.