Metronomic PLD in Patients With Primary Endocrine Resistant ABC

• Sponsor: Fudan University
• Information provided by (Responsible Party): Xichun Hu, Fudan University

Study Description

Brief Summary:

Metronomic PLD in Patients with Primary Endocrine Resistant ABC

Condition or disease	Intervention/treatment	Phase
Advanced Breast Cancer	Drug: Pegylated Liposomal Doxorubicin	Phase 2

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	46 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of Metronomic Pegylated Liposomal Doxorubicin in Patients With Primary Endocrine Resistant Advanced Breast Cancer
Actual Study Start Date :	March 1, 2017
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Contacts

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Contact: Xichun Hu, MD, PhD	64175590 ext 85006	huxicun@gmail.com
Contact: Zhonghua Wang, MD	64175590 ext 85000	zhonghuawang95@hotmail.com

Locations

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China
Fudan University Cancer Hospital	Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD 64175590 ext 85006 huxicun@gmail.com
Contact: Zhonghua Wang, MD 64175590 ext 85000 zhonghuawang95@hotmail.com

Sponsors and Collaborators

Fudan University

Investigators

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Principal Investigator:	Xichun Hu, MD, PhD	Fudan University

More Information

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Responsible Party:	Xichun Hu, Vice Director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier:	NCT03071926 History of Changes
Other Study ID Numbers:	Fudan BR2017-22
First Posted:	March 7, 2017
Last Update Posted:	February 15, 2019
Last Verified:	February 2019

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Doxorubicin; Liposomal doxorubicin	Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action