Her2-negative Metastatic Breast CancerPhase 2EASOVCWDITHABCNCT06653972
Efficacy and Safety of a Two-week Dosing Regimen of Vinorelbine Combined with Liposomal Doxorubicin in the Treatment of HER2-negative Advanced Breast Cancer
A Phase 2 study testing Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d. in people with Her2-negative Metastatic Breast Cancer and Vinorelbine, run by Wang Jiayu.
Trial summary
With advancements in various treatment modalities, the survival of breast cancer patients has continuously improved. Patients with advanced breast cancer who have undergone multiple lines of therapy still have treatment options, but standard treatment protocols are lacking. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Her2-negative Metastatic Breast Cancer, Vinorelbine, Liposomal Doxorubicin
- What is being tested?
- Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Sep 2026
- 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
- Age ≥18 years old，and ≤70 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival period not less than 12 weeks.
- At least 1 measurable lesion according to RECIST 1.1 standard.
- Previously received treatment with taxanes and anthracyclines. Note: Taxanes and anthracyclines can be utilized at various treatment stages, including neoadjuvant/adjuvant，recurrence/metastasis, with a treatment duration of at least 2 cycles (e.g., 21 days/cycle). If disease progression or intolerance occurs during a treatment regimen containing taxanes or anthracyclines, prior usage does not need to meet the above criteria.
- Patients with metastatic breast cancer have received ≥2 lines of chemotherapy. Note: The number of chemotherapy lines refers to chemotherapy agents(each regimen counting as one line, excluding endocrine therapies; maintenance therapy does not count toward the line number).
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- 6. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated HER2 negative, including IHC- and IHC 1+/2+ with FISH negative.
- 7. The organ function must meet the following requirements：
- . Blood Routine
- ANC≥1.5×109/L；
- PLT≥90×109/L；
- Hb≥90 g/L；
- . Blood Biochemistry
- TBIL≤1.5×ULN；
- ALT and AST≤2×ULN；ALT和AST≤5×ULN for patients with liver metastasis；
- BUN and Cr≤1.5×ULN and the Creatinine Clearance Rate ≥50 mL/min (Cockcroft-Gault formula calculated)；
- . Echocardiogram
- LVEF≥50%；
- . electrocardiogram
- The QT interval (QTcF) corrected by Fridericia method less than 450 ms for male and less than 470 ms for female.
- 8. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Who cannot join
- There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).
- Symptomatic or uncontrolled brain or meningeal metastases.
- Patients with only bone or skin metastasis as the assessable lesion.
- Previously suffered from other malignant tumors.
- Those who have used vinorelbine or Pegylated Liposomal Doxorubicin during the advanced disease stage.
- Individuals with a known history of allergies to the components of the interventions; History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases and a history of organ transplantation.
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- Any heart disease or other conditions evaluated unsuitable by the researcher.
- Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of reproductive age who are unwilling to take effective contraceptive measures throughout the trial period.
- According to the investigator\'s judgment, there are concomitant diseases that seriously endanger the patient\'s safety or affect the patient\'s completion of the study (including severe bleeding tendency, history of surgery within 2 weeks, hypertension beyond drug control, serious diabetes, active infection, thyroid disease, etc.).
- Having a clear history of neurological or mental disorders, including epilepsy or dementia.
- According to the RECIST 1.1 criteria, researchers determined that patients who received the last anti-tumor regimen before enrollment did not experience disease progression.
- Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated human epidermal growth factor receptor 2 (HER2) positive.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Liposomal Doxorubicin Combined with Vinorelbine in the Treatment of Advanced Metastatic Breast Cancer: a Single-Center, Prospective Phase II Clinical Study
With advancements in various treatment modalities, the survival of breast cancer patients has continuously improved. Patients with advanced breast cancer who have undergone multiple lines of therapy still have treatment options, but standard treatment protocols are lacking. Anthracyclines are a cornerstone in breast cancer treatment; however, their cumulative dose-related cardiac toxicity limits their use. Liposomal doxorubicin exhibits comparable efficacy to conventional anthracyclines and is not affected by previous cumulative doses. The combination of vinorelbine with liposomal doxorubicin shows reduced cross-toxicity, and several studies have demonstrated the effectiveness of this regimen in metastatic HER2-negative breast cancer patients.
Therefore, we aim to explore whether optimizing the dosage and treatment cycle of this combination therapy can provide a viable treatment option for metastatic HER2-negative breast cancer patients who have previously received second-line or higher chemotherapy, seeking a regimen that balances efficacy and safety.
This study is a single-center, single-arm Phase II clinical trial planned to enroll 30 metastatic HER2-negative breast cancer patients who have previously undergone second-line or higher chemotherapy. Participants will receive an optimized regimen of liposomal doxorubicin combined with vinorelbine, with safety assessed every cycle and efficacy evaluated every three cycles. Treatment will continue until radiographic evidence indicates disease progression, intolerable toxicity occurs, informed consent is withdrawn, or the investigator decides to discontinue treatment. Following treatment, each participant will undergo survival follow-up every three months until death, loss to follow-up, or withdrawal of consent.
- Being tested
- Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d.Drug
Pegylated Liposomal Doxorubicin 25mg/m2 ivgtt d1 + vinorelbine25mg/m2 ivgtt d1/q14d.
| Study group | Role | What they receive |
|---|---|---|
| PLD+NVB | Experimental | Pegylated Liposomal Doxorubicin 25mg/m2 ivgtt d1 + vinorelbine25mg/m2 ivgtt d1/q14d. Receives: Drug: Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
PFS is defined as the time from randomization to the date of confirmed radiological progression or death from any cause.
Measured: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9,...(each cycle is 14 days). The PFS will last until disease progression，up to 2 years.
Secondary outcomes (5)
overall survival (OS)
OS is defined as the time from randomization to the date of death from any cause and censored at the date of final contact for patients who were still alive.
Measured: The long-time survival will be followed every 3 months after the end of treatment,up to 5 years.
objective response rate (ORR)
ORR is defined as the proportion of patients with best response of complete response (CR) and partial response (PR) according to RECIST 1.1 standard.
Measured: Time Frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9, ......(each cycle is 14 days),assessed until cycle 15 . The efficacy will be evaluated according to RECIST 1.1 standard.
clinical benefit rate (CBR)
CBR is defined as the proportion of patients with best response of complete response (CR) , partial response (PR) and stable disease (SD) according to RECIST 1.1 standard.
Measured: Radiological examinations will be conducted every three cycles,at the end of cycle 3,6,9... (each cycle is 14 days).The efficacy will be evaluated according to RECIST 1.1 standard.
Disease Control Rate（DCR）
It is defined as the proportion of patients who achieve either a complete response (CR), a partial response (PR), or stable disease (SD) after treatment.
Measured: Radiological examinations will be conducted every three cycles,at the end of cycle 3,6,9... (each cycle is 14 days).The efficacy will be evaluated according to RECIST 1.1 standard.
Time to Progression（TTP）
It is the duration from the start of treatment until the disease shows signs of progression, such as tumor growth or the emergence of new lesions.
Measured: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9......(each cycle is 14 days). The TTP will last until disease progression,up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Her2-negative Metastatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Jiayu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Jiayu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653972
- Sponsor's protocol ID
- NCC-015985
- Acronym
- EASOVCWDITHABC
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Liposomal Doxorubicin Combined with Vinorelbine in the Treatment of Advanced Metastatic Breast Cancer: a Single-Center, Prospective Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06653972
- Acronym / sponsor ID
- EASOVCWDITHABC / NCC-015985
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wang JiayuUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Oct 2024 (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.
With advancements in various treatment modalities, the survival of breast cancer patients has continuously improved. Patients with advanced breast cancer who have undergone multiple lines of therapy still have treatment options, but standard treatment protocols are lacking. Anthracyclines are a cornerstone in breast cancer treatment; however, their cumulative dose-related cardiac toxicity limits their use. Liposomal doxorubicin exhibits comparable efficacy to conventional anthracyclines and is not affected by previous cumulative doses. The combination of vinorelbine with liposomal doxorubicin shows reduced cross-toxicity, and several studies have demonstrated the effectiveness of this regimen in metastatic HER2-negative breast cancer patients.
Therefore, we aim to explore whether optimizing the dosage and treatment cycle of this combination therapy can provide a viable treatment option for metastatic HER2-negative breast cancer patients who have previously received second-line or higher chemotherapy, seeking a regimen that balances efficacy and safety.
This study is a single-center, single-arm Phase II clinical trial planned to enroll 30 metastatic HER2-negative breast cancer patients who have previously undergone second-line or higher chemotherapy. Participants will receive an optimized regimen of liposomal doxorubicin combined with vinorelbine, with safety assessed every cycle and efficacy evaluated every three cycles. Treatment will continue until radiographic evidence indicates disease progression, intolerable toxicity occurs, informed consent is withdrawn, or the investigator decides to discontinue treatment. Following treatment, each participant will undergo survival follow-up every three months until death, loss to follow-up, or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLD+NVB | Experimental | Drug: Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d.Pegylated Liposomal Doxorubicin 25mg/m2 ivgtt d1 + vinorelbine25mg/m2 ivgtt d1/q14d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥18 years old，and ≤70 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival period not less than 12 weeks.
- At least 1 measurable lesion according to RECIST 1.1 standard.
- Previously received treatment with taxanes and anthracyclines. Note: Taxanes and anthracyclines can be utilized at various treatment stages, including neoadjuvant/adjuvant，recurrence/metastasis, with a treatment duration of at least 2 cycles (e.g., 21 days/cycle). If disease progression or intolerance occurs during a treatment regimen containing taxanes or anthracyclines, prior usage does not need to meet the above criteria.
Key exclusion criteria (12 listed)
- There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).
- Symptomatic or uncontrolled brain or meningeal metastases.
- Patients with only bone or skin metastasis as the assessable lesion.
- Previously suffered from other malignant tumors.
- Those who have used vinorelbine or Pegylated Liposomal Doxorubicin during the advanced disease stage.
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 Doxorubicin + vinorelbine,every cycle is 14d.Pegylated Liposomal Doxorubicin 25mg/m2 ivgtt d1 + vinorelbine25mg/m2 ivgtt d1/q14d. | Drug | PLD+NVB |
Primary outcome
progression-free survival (PFS)
Time frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9,...(each cycle is 14 days). The PFS will last until disease progression，up to 2 years.
PFS is defined as the time from randomization to the date of confirmed radiological progression or death from any cause.
5 secondary outcomes
overall survival (OS)
Time frame: The long-time survival will be followed every 3 months after the end of treatment,up to 5 years.
objective response rate (ORR)
Time frame: Time Frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9, ......(each cycle is 14 days),assessed until cycle 15 . The efficacy will be evaluated according to RECIST 1.1 standard.
clinical benefit rate (CBR)
Time frame: Radiological examinations will be conducted every three cycles,at the end of cycle 3,6,9... (each cycle is 14 days).The efficacy will be evaluated according to RECIST 1.1 standard.
Disease Control Rate（DCR）
Time frame: Radiological examinations will be conducted every three cycles,at the end of cycle 3,6,9... (each cycle is 14 days).The efficacy will be evaluated according to RECIST 1.1 standard.
Time to Progression（TTP）
Time frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9......(each cycle is 14 days). The TTP will last until disease progression,up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Liposomal Doxorubicin + vinorelbine,every cycle is 14d. in people with Her2-negative Metastatic Breast Cancer and Vinorelbine, run by Wang Jiayu.
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 21 inclusion and 12 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yiran Zhou (+86-15801480355, zhouyiran1021@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: Radiological examinations will be conducted every three cycles: at the end of Cycle 3, 6, 9,...(each cycle is 14 days). The PFS will last until disease progression，up to 2 years.). 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 23 Oct 2024.