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Metronomic PLD in Patients With Primary Endocrine Resistant ABC

Primary Purpose

Advanced Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pegylated Liposomal Doxorubicin

About this trial

This is an interventional treatment trial for Advanced Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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
Treatment with investigational products within 4 weeks before the study
Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction
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.

Sites / Locations

Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pegylated Liposomal Doxorubicin

Arm Description

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

Outcomes

Primary Outcome Measures

PFS

Progression Free Survival

Secondary Outcome Measures

Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0

monitoring LVEF

Overall Survival

CBR

Clinical Benefit Rate

Full Information

NCT ID

NCT03071926

First Posted

February 27, 2017

Last Updated

April 19, 2022

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03071926

Brief Title

Metronomic PLD in Patients With Primary Endocrine Resistant ABC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pegylated Liposomal Doxorubicin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pegylated Liposomal Doxorubicin

Intervention Description

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

Primary Outcome Measure Information:

Title

PFS

Description

Progression Free Survival

Time Frame

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 Outcome Measure Information:

Title

Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0

Description

monitoring LVEF

Time Frame

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

Title

Description

Overall Survival

Time Frame

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

Title

CBR

Description

Clinical Benefit Rate

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 Treatment with investigational products within 4 weeks before the study Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xichun Hu, MD, PhD

Phone

64175590

Ext

85006

huxicun@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhonghua Wang, MD

Phone

64175590

Ext

85000

zhonghuawang95@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xichun Hu, MD, PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xichun Hu, MD,PhD

Phone

64175590

Ext

85006

huxicun@gmail.com

First Name & Middle Initial & Last Name & Degree

Zhonghua Wang, MD

Phone

64175590

Ext

85000

zhonghuawang95@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Metronomic PLD in Patients With Primary Endocrine Resistant ABC

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