HER2-positive Breast CancerPhase 2NCT03933319
Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
A Phase 2 study testing pegylated liposomal doxorubicin in people with HER2-positive Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin（PLD）in combination with trastuzumab in HER-2 positive metastatic breast cancer . Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- pegylated liposomal doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2019to 1 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
- Female patients aged from 18 to 70 years old；
- Histologically confirmed as invasive breast cancer；
- HER-2 Positive（defined by: IHC 3+ or ISH positive）, regardless of HR status;
- Recurrence after adjuvant therapy or metastatic breast cancer，and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer；
- Patients must have measurable disease according to RECIST criteria Version 1.1（Brain metastases lesions and bone metastases lesions were excluded）;
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- The adverse event caused by prior therapy has recovered, or stabilized, or does not affect the study administration according to the investigator's judgment；
- Performance status 0-1；
- Life expectancy of at least 3 months；
- Left ventricular ejection fraction (LVEF)≥55%；
- Brain natriuretic peptide (BNP) and cardiac troponin T (cTnT) were in the normal range；
- Patients must have normal ECG；
- Bone marrow function: absolute neutrophil count (ANC)≥1.5×109/L，platelets≥100×109/L，hemoglobin ≥90g/L；
- Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤2.5×ULN，serum total bilirubin≤ 1.5×ULN，or ≤2.5×ULN who has Gilbert's syndrome;
- Renal function：serum creatinine≤1.5×ULN；
- Coagulation function：the international standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) or the activated partial thrombin time (APTT) ≤1.5×ULN.
Who cannot join
- Patients with symptomatic brain metastases.
- Patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug.
- Prior cumulative dose of 240 mg/m2 for doxorubicin and 400 mg/m2 for epirubicin.
- Prior treatment with anthracyclines has caused cardiotoxicity, or failed (disease progression during therapy or recurrence and metastasis within 12 months after adjuvant therapy).
- Prior mediastinal radiotherapy.
- Participation in other clinical trials within 4 weeks before enrollment.
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- Severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ECG, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension.
- Severe or uncontrolled infection.
- Positivity for HIV, Hepatitis B or C.
- Active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin).
- Patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation.
- Need to concurrent other cancer therapy(other than palliative care for non-target lesions).
- Other ineligible conditions according to the researcher's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peng Yuan
Beijing, Beijing Municipality, 100021
peng yuan, Prof, 13501270834 ext. 13501270834, yuanpeng01@hotmail.com
xue wang, Dr, 13811967690 ext. 13501270834, wxyxuki@163.com
About this study
This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin（PLD）in combination with trastuzumab in HER-2 positive metastatic breast cancer .
- Conditions
- HER2-positive Breast Cancer
- Being tested
- pegylated liposomal doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicinDrug
Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| PLD in combination with trastuzumab | Experimental | Trastuzumab: administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days.
pegylated liposomal doxorubicin(PLD):administered at dose of 35mg/m2 IV once every 21 days. Receives: Drug: pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The ORR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve complete response (CR) and partial response (PR)
Measured: approximately 6 months
Secondary outcomes (2)
Progression-free survival (PFS)
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Measured: approximately 1.5 years
Incidence and Severity of adverse events
Measured: approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start11 Mar 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- peng yuan, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933319
- Sponsor's protocol ID
- CSPC-DMS-BC-11
- Status last verified
- Jul 2020
- First submitted
- 29 Apr 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of Pegylated Liposomal Doxorubicin（PLD）Plus Trastuzumab in HER-2 Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03933319
- Acronym / sponsor ID
- CSPC-DMS-BC-11
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center phase Ⅱ study designed to evaluated the efficacy and safety of pegylated liposomal doxorubicin（PLD）in combination with trastuzumab in HER-2 positive metastatic breast cancer .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLD in combination with trastuzumab | Experimental | Drug: pegylated liposomal doxorubicinTrastuzumab: administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days. pegylated liposomal doxorubicin(PLD):administered at dose of 35mg/m2 IV once every 21 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to understand and voluntarily receive the research procedures according to protocol,willingness to sign the written informed consent document;
- Female patients aged from 18 to 70 years old；
- Histologically confirmed as invasive breast cancer；
- HER-2 Positive（defined by: IHC 3+ or ISH positive）, regardless of HR status;
- Recurrence after adjuvant therapy or metastatic breast cancer，and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer；
Key exclusion criteria (13 listed)
- Patients with symptomatic brain metastases.
- Patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug.
- Prior cumulative dose of 240 mg/m2 for doxorubicin and 400 mg/m2 for epirubicin.
- Prior treatment with anthracyclines has caused cardiotoxicity, or failed (disease progression during therapy or recurrence and metastasis within 12 months after adjuvant therapy).
- Prior mediastinal radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated liposomal doxorubicinEligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity | Drug | PLD in combination with trastuzumab |
Primary outcome
Objective response rate (ORR)
Time frame: approximately 6 months
The ORR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve complete response (CR) and partial response (PR)
2 secondary outcomes
Progression-free survival (PFS)
Time frame: approximately 1.5 years
Incidence and Severity of adverse events
Time frame: approximately 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
peng yuan principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegylated liposomal doxorubicin in people with HER2-positive Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact peng yuan, Prof (13501270834 ext. 13501270834, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.