Metronomic PLD in Patients With Primary Endocrine Resistant ABC

NCT ID: NCT03071926

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-12-01

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

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegylated Liposomal Doxorubicin

Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks

Group Type: EXPERIMENTAL

Pegylated Liposomal Doxorubicin

Intervention Type: DRUG

20 mg, qw, first 6 weeks ,every 8 weeks

Interventions

Pegylated Liposomal Doxorubicin

20 mg, qw, first 6 weeks ,every 8 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Vice Director of department of medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichun Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xichun Hu, MD, PhD

Role: CONTACT

huxicun@gmail.com

64175590 ext. 85006

Zhonghua Wang, MD

Role: CONTACT

zhonghuawang95@hotmail.com

64175590 ext. 85000

Facility Contacts

Xichun Hu, MD,PhD

Role: primary

huxicun@gmail.com

64175590 ext. 85006

Zhonghua Wang, MD

Role: backup

zhonghuawang95@hotmail.com

64175590 ext. 85000

Other Identifiers

Fudan BR2017-22

Identifier Type: -

Identifier Source: org_study_id