Metronomic PLD in Patients With Primary Endocrine Resistant ABC

NCT03071926 | Unknown Phase 2

• 1 other identifier: Fudan BR2017-22
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Metronomic PLD in Patients with Primary Endocrine Resistant ABC

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

  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

  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

Study Arms (1)

Pegylated Liposomal Doxorubicin

EXPERIMENTAL

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

Drug: Pegylated Liposomal Doxorubicin

Interventions

Pegylated Liposomal Doxorubicin DRUG

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

Pegylated Liposomal Doxorubicin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

liposomal doxorubicin

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, MD, PhD

CONTACT

64175590; huxicun@gmail.com

Zhonghua Wang, MD

CONTACT

64175590; zhonghuawang95@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of department of medical oncology

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 7, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)