Metronomic PLD in Patients With Primary Endocrine Resistant ABC

Advanced Breast Cancer Clinical Trial

Official title:

Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients With Primary Endocrine Resistant Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03071926
• Other study ID #: Fudan BR2017-22
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2022
• Source: Fudan University
• Contact: Xichun Hu, MD, PhD
• Phone: 64175590
• Email: huxicun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Metronomic PLD in Patients with Primary Endocrine Resistant ABC

Description:

Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients with Primary Endocrine Resistant Advanced Breast Cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression Free Survival	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
Secondary	Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0	monitoring LVEF	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
Secondary	OS	Overall Survival	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
Secondary	CBR	Clinical Benefit Rate	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