Metronomic PLD in Patients With Primary Endocrine Resistant ABC

Study Overview
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Brief Summary
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Metronomic PLD in Patients with Primary Endocrine Resistant ABC

Detailed Description
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Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients with Primary Endocrine Resistant Advanced Breast Cancer

Official Title
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Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients With Primary Endocrine Resistant Advanced Breast Cancer

Conditions
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Advanced Breast Cancer

Intervention / Treatment
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* Drug: Pegylated Liposomal Doxorubicin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegylated Liposomal Doxorubicin<br>Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks | Drug: Pegylated Liposomal Doxorubicin<br>* 20 mg, qw, first 6 weeks ,every 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0 | monitoring LVEF | 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 | 
| OS | Overall Survival | 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 | 
| CBR | Clinical Benefit Rate | 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 |