Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
Primary Purpose
Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
utidelone
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 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;
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.
Exclusion Criteria:
- 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);
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Utidelone
Arm Description
Drug: utidelone Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective response rate (ORR)
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria
Overall Survival (OS)
From enrollment to death (for any reason)
Duration of Response (DOR)
The first evaluation of CR or PR to progression or death (for any reason)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05403333
Brief Title
Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
Official Title
Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 10, 2022 (Anticipated)
Primary Completion Date
March 9, 2023 (Anticipated)
Study Completion Date
March 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Utidelone
Arm Type
Experimental
Arm Description
Drug: utidelone Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days
Intervention Type
Drug
Intervention Name(s)
utidelone
Other Intervention Name(s)
Singel arm
Intervention Description
Utidelone Injection: 65 mg/m2/day, IV on day 1, 8, and 15 every 28 days
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
Estimated 12 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The proportion of patients with a best response of CR or PR, according to RECIST 1.1 criteria
Time Frame
Estimated 12 months
Title
Overall Survival (OS)
Description
From enrollment to death (for any reason)
Time Frame
Estimated 24 months
Title
Duration of Response (DOR)
Description
The first evaluation of CR or PR to progression or death (for any reason)
Time Frame
Estimated 12 months
Title
Overall summary of adverse events following intravenous administration of utidelone (safety analysis set)
Description
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.
Time Frame
Estimated 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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);
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
We'll reach out to this number within 24 hrs