Metronomic PLD in Patients With Primary Endocrine Resistant ABC
Study Details
Study Description
Brief Summary
Metronomic PLD in Patients with Primary Endocrine Resistant ABC
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients with Primary Endocrine Resistant Advanced Breast Cancer
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pegylated Liposomal Doxorubicin Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks |
Drug: Pegylated Liposomal Doxorubicin
20 mg, qw, first 6 weeks ,every 8 weeks
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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
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Treatment with investigational products within 4 weeks before the study
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Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Cancer Hospital | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Xichun Hu, MD, PhD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Fudan BR2017-22