Metronomic PLD in Patients With Primary Endocrine Resistant ABC

April 19, 2022 updated by: Xichun Hu, Fudan University

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

Metronomic PLD in Patients with Primary Endocrine Resistant ABC

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin: 20 mg, qw, first 6 weeks ,every 8 weeks
Drug: Pegylated Liposomal Doxorubicin
20 mg, qw, first 6 weeks ,every 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and grade of treatment-related cardiotoxicity as assessed by CTCAE v4.0
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
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
OS
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
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
CBR
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan BR2017-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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