Metronomic PLD in Patients With Primary Endocrine Resistant ABC
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ClinicalTrials.gov Identifier: NCT03071926 |
Recruitment Status
:
Recruiting
First Posted
: March 7, 2017
Last Update Posted
: January 23, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Breast Cancer | Drug: Pegylated Liposomal Doxorubicin | Phase 2 |
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 : | March 2018 |
Estimated Study Completion Date : | March 2019 |

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
|
- 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
- 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
- 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
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071926
Contact: Xichun Hu, MD, PhD | 64175590 ext 85006 | huxicun@gmail.com | |
Contact: Zhonghua Wang, MD | 64175590 ext 85000 | zhonghuawang95@hotmail.com |
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 |
Principal Investigator: | Xichun Hu, MD, PhD | Fudan University |
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 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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 |