AzTrials
AzTrials

Breast CancerPhase 2NeoURANIANCT06510465

Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)

A Phase 2 study testing utidelone, Cisplatin and Trastuzumab in people with Breast Cancer, run by RenJi Hospital at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
utidelone, Cisplatin and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
2 sitesChina
Study dates
1 Aug 2024to 31 Mar 2032
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old;
  • Primary invasive breast cancer confirmed by pathology; Before neoadjuvant therapy, the primary breast lesion was larger than 2cm(cT2-T4a-d, according to the anatomical staging of AJCC 8th edition), or the clinical images of lymph nodes considered metastasis or pathologically confirmed metastasis (CN+); or patients whose primary breast lesions are more than 1cm and less than 2cm, and whose lymph nodes have not metastasized (cT1cN0) must meet one of the following conditions: hormone receptor negative, HER2 positive, or ki67 greater than 20%. If bilateral breast cancer is found at the same time, it can be admitted to the group, but it is necessary to determine which side of the lesion is to be evaluated before taking the drug;
  • According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;
  • The score of ECOG is 0 or 1;
  • During neoadjuvant therapy, ovarian function suppression can be given at the same time;
  • The hematological examination and blood biochemical examination should meet the following requirements: white blood cell count (WBC)≥3.0×109/L, neutrophil count (ANC)≥1.5×109/L and platelet count (PLT) ≥ 75× 109/L; Hemoglobin (HB) ≥ 80g/L; Total bilirubin (TBIL)≤1.5× upper limit of normal value (ULN), AST(sGOT), ALT(sGPT)≤2×ULN and creatinine (Cr) ≤ 1.5× ULN;
  • creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);
  • Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.

Who cannot join

  • Patients during pregnancy and lactation, patients with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;
  • There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;
  • There is evidence of sensory or motor nerve diseases;
  • Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;
  • allergic to the research drug or its auxiliary materials;
  • Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of the study;
  • Previous history of other malignant tumors, except the cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and the second primary malignant tumor with high 5-year recurrence-free survival rate determined by researchers;
  • According to the researcher's judgment, there are accompanying diseases (including but not limited to uncontrollable hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study, and any other circumstances that the researcher judges that the patient is not suitable for participating in this study.

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

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127

  • Renji Hospital

    Shanghai

Other trials in China

About this study

Official title: Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA): A Multi-center, Prospective Study

This study is a prospective, multi-center, single-arm, two-cohort, exploratory study, aiming to explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in breast cancer patients.

Read the detailed description

Explore the effectiveness and safety of neoadjuvant treatment with weekly utidelone combined with cisplatin in high risk early, locally advanced and Inflammatory breast cancer patients.

Conditions
Breast Cancer
Being tested
utidelone, Cisplatin, Trastuzumab, Pertuzumab
Keywords
breast cancer, utidelone, cisplatin, neoadjuvant therapy
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 UTD1

    utidelone 50mg／m2，ivgtt，d1，8，15，22, q28d, up to 4 cycle；

  • CisplatinDrug

    Also called DDP

    cisplatin25mg/m2，ivgtt，d1，8，15；q28d, up to 4 cycle.

  • TrastuzumabDrug

    Trastuzumab 8mg/kg, ivgtt, d1, then 6mg/kg, q21d or Trastuzumab 4mg/kg, ivgtt, d1, then 2mg/kg, q7d or Trastuzumab Injection（Subcutaneous Injection）600mg，subcutaneous Injection，d1，q21d

  • PertuzumabDrug

    Pertuzumab 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase

Study groups in NCT06510465
Study groupRoleWhat they receive
HER2 negative breast cancer cohortExperimentalHuman Epidermal Growth Factor Receptor 2 (HER2 ) negative breast cancer utidelone and cisplatin
Receives: Drug: utidelone; Drug: Cisplatin
HER2 positive breast cancer cohortExperimentalHuman Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone，cisplatin，tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used)
Receives: Drug: utidelone; Drug: Cisplatin; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pCR

    ypT0/is ypN0

    Measured: through surgery completion, an average of 16 weeks

Secondary outcomes (16)

  1. breast pCR

    ypT0/is

    Measured: through surgery completion, an average of 16 weeks

  2. RCB 0/I rate

    ratio of patients who achieved RCB 0 or RCB I

    Measured: through surgery completion, an average of 16 weeks

  3. RCB class

    RCB 0, RCB I, RCB II, RCB III

    Measured: through surgery completion, an average of 16 weeks

  4. Rate of lymph node negative

    ratio of patients who achieved lymph node negative

    Measured: through surgery completion, an average of 16 weeks

  5. ORR by physical examination

    ratio of patients who achieved complete response or partial response by physical examination

    Measured: After completing neoadjuvant therapy before surgery, an average of 16 weeks

  6. ORR by MRI

    ratio of patients who achieved complete response or partial response by MRI

    Measured: After completing neoadjuvant therapy before surgery, an average of 16 weeks

  7. CBR by physical examination

    ratio of patients who achieved complete response or partial response or stable disease by physical examination

    Measured: After completing neoadjuvant therapy before surgery, an average of 16 weeks

  8. CBR by MRI

    ratio of patients who achieved complete response or partial response or stable disease by MRI

    Measured: After completing neoadjuvant therapy before surgery, an average of 16 weeks

  9. iDFS

    It is defined as the time from first dose of study intervention administration to the first occurrence of ipsilateral invasive cancer recurrence, contralateral invasive breast cancer, local and/or regional invasive cancer recurrence, distant metastasis or death from any cause.

    Measured: 2year,3year,5year,8year,10year

  10. EFS

    It is defined as the time from first dose of study intervention administration to the first occurrence of local and/or regional recurrence, contralateral breast cancer, distant metastasis or death from any cause.

    Measured: 2year,3year,5year,8year,10year

  11. DDFS

    It is defined as the time from first dose of study intervention administration to the first distant metastasis or death from any cause.

    Measured: 2year,3year,5year,8year,10year

  12. OS

    It is defined as the time from first dose of study intervention administration to death from any cause.

    Measured: 2year,3year,5year,8year,10year

  13. Quality of Life

    EORTC-QLQ-C30

    Measured: Through study completion，an average of 1 year

  14. Quality of Life

    EORTC-QLQ-BR23

    Measured: Through study completion，an average of 1 year

  15. Safety

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Through study completion，an average of 1 year

  16. Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients

    Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients

    Measured: After completing neoadjuvant therapy before surgery, an average of 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2032 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
143 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510465
Sponsor's protocol ID
SHPD009
Acronym
NeoURANIA
Status last verified
Jul 2024
First submitted
23 May 2024
Last updated
19 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing utidelone, Cisplatin and Trastuzumab in people with Breast Cancer, run by RenJi Hospital 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Jul 2024. 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 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?

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?

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?

pCR (time frame: through surgery completion, an average of 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06510465.

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 19 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in