Advanced Breast Cancer
Conditions
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
Interventions
DRUGPegylated Liposomal Doxorubicin
20 mg, qw, first 6 weeks ,every 8 weeks
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Females with age between 18 and 75 years old 2. ECOG: 0～2 3. Life expectancy longer than 3 months 4. Histological proven unresectable recurrent or metastatic HR positive/HER2 negative breast cancer 5. 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 6. At least one measurable disease according to RECIST 1.1(except for bone metastasis only) 7. LVEF ≥ 55% 8. No radiation therapy within 4 weeks prior to enrollment 9. 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 10. Be willing to participate in the study, sign informed consent and cooperate with the follow-up
Exclusion criteria
1. Previous accumulated or equivalent dose of doxorubicin ≥300mg/m2 2. Intervals of anthracycline-based adjuvant chemotherapy ≤1 year (time between anthracycline-based adjuvant or neoadjuvant chemotherapy and disease relapse) 3. 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 4. Pregnant or lactating women and gestational age women who are unable to use effective contraception 5. Treatment with investigational products within 4 weeks before the study 6. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction 7. Severe or uncontrolled infection 8. Psychiatric drugs abuse and unable to withdrawal or mental disorders 9. Other malignancies, except for cured skin basal cell carcinoma and cervical intraepithelial neoplasia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 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 | Progression Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0 | 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 | monitoring LVEF |
| OS | 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 | Overall Survival |
| CBR | 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 | Clinical Benefit Rate |
Countries
China
Contacts
Primary ContactXichun Hu, MD, PhD
Backup ContactZhonghua Wang, MD
Outcome results
None listed