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

July 14, 2024 updated by: RenJi Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
143

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Renji hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old;
  2. 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;
  3. According to the RECIST version 1.1 standard (see Annex I), there is at least one measurable lesion before neoadjuvant therapy;
  4. The score of ECOG is 0 or 1;
  5. During neoadjuvant therapy, ovarian function suppression can be given at the same time;
  6. 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;
  7. creatinine clearance rate ≥50mL/min(Cockcroft-Gault formula);
  8. Subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.

Exclusion Criteria:

  1. 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;
  2. There is distant metastasis of breast cancer confirmed by imaging or pathology before enrollment;
  3. There is evidence of sensory or motor nerve diseases;
  4. Severe cardiopulmonary insufficiency, severe hepatic and renal insufficiency, severe concomitant disease or active infection, including known HIV infection;
  5. allergic to the research drug or its auxiliary materials;
  6. 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;
  7. 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;
  8. 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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HER2 negative breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) negative breast cancer utidelone and cisplatin
Drug: utidelone
utidelone 50mg／m2，ivgtt，d1，8，15，22, q28d, up to 4 cycle；
Other Names:
  • UTD1
Drug: Cisplatin
cisplatin25mg/m2，ivgtt，d1，8，15；q28d, up to 4 cycle.
Other Names:
  • DDP
Experimental: HER2 positive breast cancer cohort
Human Epidermal Growth Factor Receptor 2 (HER2 ) positive breast cancer utidelone，cisplatin，tratuzumab and pertuzumab (both Intravenous preparations or subcutaneous preparations can be used)
Drug: utidelone
utidelone 50mg／m2，ivgtt，d1，8，15，22, q28d, up to 4 cycle；
Other Names:
  • UTD1
Drug: Cisplatin
cisplatin25mg/m2，ivgtt，d1，8，15；q28d, up to 4 cycle.
Other Names:
  • DDP
Drug: Trastuzumab
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
Drug: Pertuzumab
Pertuzumab 840mg, ivgtt, d1, then 420mg, q21d or Pertuzumab/trastuzumab/hyaluronidase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pCR
Time Frame: through surgery completion, an average of 16 weeks
ypT0/is ypN0
through surgery completion, an average of 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
breast pCR
Time Frame: through surgery completion, an average of 16 weeks
ypT0/is
through surgery completion, an average of 16 weeks
RCB 0/I rate
Time Frame: through surgery completion, an average of 16 weeks
ratio of patients who achieved RCB 0 or RCB I
through surgery completion, an average of 16 weeks
RCB class
Time Frame: through surgery completion, an average of 16 weeks
RCB 0, RCB I, RCB II, RCB III
through surgery completion, an average of 16 weeks
Rate of lymph node negative
Time Frame: through surgery completion, an average of 16 weeks
ratio of patients who achieved lymph node negative
through surgery completion, an average of 16 weeks
ORR by physical examination
Time Frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
ratio of patients who achieved complete response or partial response by physical examination
After completing neoadjuvant therapy before surgery, an average of 16 weeks
ORR by MRI
Time Frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
ratio of patients who achieved complete response or partial response by MRI
After completing neoadjuvant therapy before surgery, an average of 16 weeks
CBR by physical examination
Time Frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
ratio of patients who achieved complete response or partial response or stable disease by physical examination
After completing neoadjuvant therapy before surgery, an average of 16 weeks
CBR by MRI
Time Frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
ratio of patients who achieved complete response or partial response or stable disease by MRI
After completing neoadjuvant therapy before surgery, an average of 16 weeks
iDFS
Time Frame: 2year,3year,5year,8year,10year
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.
2year,3year,5year,8year,10year
EFS
Time Frame: 2year,3year,5year,8year,10year
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.
2year,3year,5year,8year,10year
DDFS
Time Frame: 2year,3year,5year,8year,10year
It is defined as the time from first dose of study intervention administration to the first distant metastasis or death from any cause.
2year,3year,5year,8year,10year
OS
Time Frame: 2year,3year,5year,8year,10year
It is defined as the time from first dose of study intervention administration to death from any cause.
2year,3year,5year,8year,10year
Quality of Life
Time Frame: Through study completion，an average of 1 year
EORTC-QLQ-C30
Through study completion，an average of 1 year
Quality of Life
Time Frame: Through study completion，an average of 1 year
EORTC-QLQ-BR23
Through study completion，an average of 1 year
Safety
Time Frame: Through study completion，an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Through study completion，an average of 1 year
Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients
Time Frame: After completing neoadjuvant therapy before surgery, an average of 16 weeks
Combine with weekly paclitaxel with cispltin in HER2-negative and HER2-positive patients
After completing neoadjuvant therapy before surgery, an average of 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHPD009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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