Clinical trial · Interventional
Metronomic PLD in Patients With Primary Endocrine Resistant ABC
Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients With Primary Endocrine Resistant Advanced Breast Cancer
NCT03071926CI-TRIAL-00057910unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Metronomic PLD in Patients with Primary Endocrine Resistant ABC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated Liposomal Doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pegylated Liposomal Doxorubicin
- description
- Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks
- interventionNames
- Drug: Pegylated Liposomal Doxorubicin
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 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
- description
- Progression Free Survival
Secondary outcomes (3)
- measure
- Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.