HER2-negative Breast CancerPhase 2NCT04624711
Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer
A Phase 2 study testing Eribulin Mesylate and Anlotinib hydrochloride in people with HER2-negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a multicenter, phase II, open-label, single-arm investigator initiated trial to evaluate the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- HER2-negative Breast Cancer
- What is being tested?
- Eribulin Mesylate and Anlotinib hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to Dec 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient volunteers and signs an informed consent form;
- Age ≥18 years old, female;
- The patient was diagnosed as HER2 negative breast cancer by histopathology ( HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is at least 1 measurable lesion of metastasis according to RECIST 1.1;
- All patients have previously underwent chemotherapy containing anthracyclines and taxanes, and received ≥1 line chemotherapy for metastatic breast cancer;
- Patients with hormone receptor positive (ER positive (IHC ER positive percentage ≥1%), PR positive (IHC PR positive percentage ≥1%)) have underwent ≥1 line endocrine therapy;
- Physical condition ECOG PS: 0-1;
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- Laboratory tests meet the following criteria:
- Bone marrow function: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥90g/L;
- Liver function: serum total bilirubin (STB), combined bilirubin (CB) ≤ upper limit of normal (ULN) *1.5; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN*2.5;
- Renal function: serum creatinine (Cr) ≤ ULN; endogenous creatinine clearance (Ccr) ≥ 60 ml / min (calculated using the Cockcroft-Gault formula).
Who cannot join
- Previous breast cancer history (except for ipsilateral DCIS that only received local treatment ≥5 years ago), malignant tumors of other histological origins (except for non-melanoma skin cancer or cervical carcinoma in situ) unless the patient's tumor had been completely alleviated and had not received treatment for at least 5 years before the enrollment date;
- Major surgery within 4 weeks prior to enrollment, or surgical wounds have not healed;
- Embolization and bleeding occurred within 4 weeks before enrollment;
- Severe cardiovascular disease, including hypertension (BP≥160/95mmHg) uncontrolled by medical treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, severe heart rhythm Abnormalities and pericardial effusions;
- Severe infection requires intravenous antibiotic, antifungal or antiviral treatment;
- Other clinical trials of drugs were used in the first four weeks of the first medication;
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- Subjects with treatment history of eribulin or anti-angiogenesis drugs;
- Suffering from mental illness, poor compliance;
- Researchers believe that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210000
Jinhai Tang
About this study
Official title: A Multicenter, Phase II, Open-label, Single-arm Investigator Initiated Trial to Evaluate the Efficacy and Safety of Eribulin Mesylate Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer Patients
This is a multicenter, phase II, open-label, single-arm investigator initiated trial to evaluate the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients.
Read the detailed description
Breast cancer is the most frequent malignancy in women worldwide. Treatments on metastatic HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.
This study explores the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients. The primary objective is to evaluate the progression free survival (PFS). The secondary objective is to evaluate the safety of the combination of eribulin and anlotinib.
- Conditions
- HER2-negative Breast Cancer
- Being tested
- Eribulin Mesylate, Anlotinib hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin MesylateDrug
Also called Halaven
Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
Anlotinib hydrochlorideDrug
Also called Anlotinib
Anlotinib 12mg, administered orally on Days 1-14 of each 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin Mesylate Combined With Anlotinib | Experimental | Patients receive eribulin mesylate plus anlotinib. Receives: Drug: Eribulin Mesylate; Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Measured: 2 year
Secondary outcomes (1)
The Number of Participants Who Experienced Adverse Events (AE)
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Mar 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624711
- Sponsor's protocol ID
- EAGER-001
- Status last verified
- May 2021
- First submitted
- 5 Nov 2020
- Last updated
- 21 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II, Open-label, Single-arm Investigator Initiated Trial to Evaluate the Efficacy and Safety of Eribulin Mesylate Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04624711
- Acronym / sponsor ID
- EAGER-001
- Conditions
- HER2-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Nov 2020 (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 multicenter, phase II, open-label, single-arm investigator initiated trial to evaluate the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients.
Detailed description
Breast cancer is the most frequent malignancy in women worldwide. Treatments on metastatic HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.
This study explores the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients. The primary objective is to evaluate the progression free survival (PFS). The secondary objective is to evaluate the safety of the combination of eribulin and anlotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin Mesylate Combined With Anlotinib | Experimental | Drug: Eribulin Mesylate, Drug: Anlotinib hydrochloridePatients receive eribulin mesylate plus anlotinib. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient volunteers and signs an informed consent form;
- Age ≥18 years old, female;
- The patient was diagnosed as HER2 negative breast cancer by histopathology ( HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is at least 1 measurable lesion of metastasis according to RECIST 1.1;
- All patients have previously underwent chemotherapy containing anthracyclines and taxanes, and received ≥1 line chemotherapy for metastatic breast cancer;
- Patients with hormone receptor positive (ER positive (IHC ER positive percentage ≥1%), PR positive (IHC PR positive percentage ≥1%)) have underwent ≥1 line endocrine therapy;
Key exclusion criteria (9 listed)
- Previous breast cancer history (except for ipsilateral DCIS that only received local treatment ≥5 years ago), malignant tumors of other histological origins (except for non-melanoma skin cancer or cervical carcinoma in situ) unless the patient's tumor had been completely alleviated and had not received treatment for at least 5 years before the enrollment date;
- Major surgery within 4 weeks prior to enrollment, or surgical wounds have not healed;
- Embolization and bleeding occurred within 4 weeks before enrollment;
- Severe cardiovascular disease, including hypertension (BP≥160/95mmHg) uncontrolled by medical treatment, unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, severe heart rhythm Abnormalities and pericardial effusions;
- Severe infection requires intravenous antibiotic, antifungal or antiviral treatment;
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 |
|---|---|---|
| Eribulin MesylateAlso: HalavenEribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle. | Drug | Eribulin Mesylate Combined With Anlotinib |
| Anlotinib hydrochlorideAlso: AnlotinibAnlotinib 12mg, administered orally on Days 1-14 of each 21 day cycle. | Drug | Eribulin Mesylate Combined With Anlotinib |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 year
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
1 secondary outcome
The Number of Participants Who Experienced Adverse Events (AE)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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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.
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 Eribulin Mesylate and Anlotinib hydrochloride in people with HER2-negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 10 inclusion and 9 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 21 May 2021. 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 Yongmei Yin (13951842727, ymyin@njmu.edu.cn), 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: 2 year). 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 21 May 2021.