Metronomic PLD in Patients With Primary Endocrine Resistant ABC
Primary Purpose
Advanced Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pegylated Liposomal Doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Females with age between 18 and 75 years old
- ECOG: 0~2
- Life expectancy longer than 3 months
- Histological proven unresectable recurrent or metastatic HR positive/HER2 negative breast cancer
- Primary endocrine resistance is defined as: a relapse while on the first 2 years of adjuvant ET, or PD within first 6 months of first-line ET for MBC, while on ET
- At least one measurable disease according to RECIST 1.1(except for bone metastasis only)
- LVEF ≥ 55%
- No radiation therapy within 4 weeks prior to enrollment
- Normal function of major organs: Hb ≥ 90 g/L (no blood transfusion within 14 days) ;ANC ≥1.5×109 /L;PLT ≥75×109 /L;TBIL≤1. 5×ULN; ALT、 AST≤ 3×ULN(ALT、 AST≤ 5×ULN with hepatic metastases); serum Cr ≤ 1×ULN
- Be willing to participate in the study, sign informed consent and cooperate with the follow-up
Exclusion Criteria:
- Previous accumulated or equivalent dose of doxorubicin ≥300mg/m2
- Intervals of anthracycline-based adjuvant chemotherapy ≤1 year (time between anthracycline-based adjuvant or neoadjuvant chemotherapy and disease relapse)
- Patients with symptomatic central nervous system metastases. Except for patients with stable and asymptomatic brain metastases for at least 8 weeks and no need for glucocorticoids or mannitol treatment before the trial and at least one measurable lesion outside the brain. Radiotherapy for brain metastases should be completed at least 4 weeks before the registration
- Pregnant or lactating women and gestational age women who are unable to use effective contraception
- Treatment with investigational products within 4 weeks before the study
- Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
- Severe or uncontrolled infection
- Psychiatric drugs abuse and unable to withdrawal or mental disorders
- Other malignancies, except for cured skin basal cell carcinoma and cervical intraepithelial neoplasia.
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pegylated Liposomal Doxorubicin
Arm Description
Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0
monitoring LVEF
OS
Overall Survival
CBR
Clinical Benefit Rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03071926
Brief Title
Metronomic PLD in Patients With Primary Endocrine Resistant ABC
Official Title
Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients With Primary Endocrine Resistant Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (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
Metronomic PLD in Patients with Primary Endocrine Resistant ABC
Detailed Description
Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients with Primary Endocrine Resistant Advanced Breast Cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced 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
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pegylated Liposomal Doxorubicin
Arm Type
Experimental
Arm Description
Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated Liposomal Doxorubicin
Intervention Description
20 mg, qw, first 6 weeks ,every 8 weeks
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Outcome Measure Information:
Title
Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0
Description
monitoring LVEF
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Title
OS
Description
Overall Survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Title
CBR
Description
Clinical Benefit Rate
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females with age between 18 and 75 years old
ECOG: 0~2
Life expectancy longer than 3 months
Histological proven unresectable recurrent or metastatic HR positive/HER2 negative breast cancer
Primary endocrine resistance is defined as: a relapse while on the first 2 years of adjuvant ET, or PD within first 6 months of first-line ET for MBC, while on ET
At least one measurable disease according to RECIST 1.1(except for bone metastasis only)
LVEF ≥ 55%
No radiation therapy within 4 weeks prior to enrollment
Normal function of major organs: Hb ≥ 90 g/L (no blood transfusion within 14 days) ;ANC ≥1.5×109 /L;PLT ≥75×109 /L;TBIL≤1. 5×ULN; ALT、 AST≤ 3×ULN(ALT、 AST≤ 5×ULN with hepatic metastases); serum Cr ≤ 1×ULN
Be willing to participate in the study, sign informed consent and cooperate with the follow-up
Exclusion Criteria:
Previous accumulated or equivalent dose of doxorubicin ≥300mg/m2
Intervals of anthracycline-based adjuvant chemotherapy ≤1 year (time between anthracycline-based adjuvant or neoadjuvant chemotherapy and disease relapse)
Patients with symptomatic central nervous system metastases. Except for patients with stable and asymptomatic brain metastases for at least 8 weeks and no need for glucocorticoids or mannitol treatment before the trial and at least one measurable lesion outside the brain. Radiotherapy for brain metastases should be completed at least 4 weeks before the registration
Pregnant or lactating women and gestational age women who are unable to use effective contraception
Treatment with investigational products within 4 weeks before the study
Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
Severe or uncontrolled infection
Psychiatric drugs abuse and unable to withdrawal or mental disorders
Other malignancies, except for cured skin basal cell carcinoma and cervical intraepithelial neoplasia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xichun Hu, MD, PhD
Phone
64175590
Ext
85006
Email
huxicun@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhonghua Wang, MD
Phone
64175590
Ext
85000
Email
zhonghuawang95@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, MD, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichun Hu, MD,PhD
Phone
64175590
Ext
85006
Email
huxicun@gmail.com
First Name & Middle Initial & Last Name & Degree
Zhonghua Wang, MD
Phone
64175590
Ext
85000
Email
zhonghuawang95@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Metronomic PLD in Patients With Primary Endocrine Resistant ABC
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