Overview

Metronomic PLD in Patients With Primary Endocrine Resistant ABC

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
Female
Summary
Metronomic PLD in Patients with Primary Endocrine Resistant ABC
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Doxorubicin
Liposomal doxorubicin
Criteria
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.