Triple Negative Breast CancerPhase 2EMBRAVE-001NCT04502680

Maintenance Treatment With Eribulin Mesylate Versus Observation in Triple Negative Breast Cancer Patients

A Phase 2 study testing Eribulin Mesylate in people with Triple Negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This clinical trial is a multicenter, randomized, open-label, phase-II study to evaluate the efficacy and safety of maintenance treatment with eribulin mesylate following standard adjuvant chemotherapy in triple negative breast cancer patients. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Triple Negative Breast Cancer
What is being tested?: Eribulin Mesylate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: Jun 2021to Jun 2024
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 years and older
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 triple-negative breast cancer by histopathology (ER negative (IHC ER positive percentage <1%), PR negative (IHC PR positive percentage <1%), HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is no evidence of metastasis;
Patients underwent radical or breast conserving surgery combined with sentinel lymph node biopsy for primary breast cancer. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
For patients who have previously received neoadjuvant therapy for triple-negative breast cancer containing anthracyclines and taxanes, the postoperative efficacy evaluation did not reach pathological complete remission (non-PCR), that is, the primary breast and/or metastatic regional lymph nodes still have histological evidence of malignant tumors other than carcinoma in situ;
For patients who have not received neoadjuvant therapy for triple-negative breast cancer, ≥1 ipsilateral axillary lymph nodes have pathological tumor involvement after surgery. Or the patient's postoperative lymph nodes are negative, but at least meet one of the following conditions:

Show all 16Show fewer

Primary invasive tumor size> 2cm in pathology;
Ki-67 index of untreated breast tissue>30%;
The comprehensive score is at least 8 points (Elston and Ellis 1991) according to the improved Bloom-Richardson grading system (also known as the Nottingham scale), which belongs to the 3rd level;
Physical condition ECOG PS: 0-1;
Previously received adjuvant chemotherapy consisting of a minimum of 6 courses with anthracyclines combined taxanes;
Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks;
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

Patients with metastatic breast cancer (including contralateral axillary lymph nodes), inflammatory carcinomas;
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;
Suffering from mental illness, poor compliance;
Researchers believe that it is not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Wei Li contact

Yongmei Yin contact

China1 site

Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Maintenance Treatment With Eribulin Mesylate Following Standard Adjuvant Chemotherapy in Triple Negative Breast Cancer Patients

Read the detailed description

Triple negative breast cancer (TNBC) is an aggressive disease with high relapse rates and poor overall survival. This study explores the role of maintenance treatment with eribulin following standard adjuvant chemotherapy in TNBC. Patients will be randomized to receive eribulin mesylate maintenance treatment or observation after standard adjuvant chemotherapy.

The primary objective is to evaluate the disease free survival (DFS). The secondary objective is to evaluate the overall survival (OS), objective response rate (ORR) and the safety of eribulin mesylate maintenance treatment.

Conditions: Triple Negative Breast Cancer
Being tested: Eribulin Mesylate
Medical subject headings: Triple Negative Breast Neoplasms

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.

Study groups in NCT04502680
Study group	Role	What they receive
Eribulin Mesylate	Experimental	Patients receive eribulin mesylate following standard adjuvant chemotherapy. Receives: Drug: Eribulin Mesylate
Observation	No intervention	Observation. No intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease Free Survival (DFS)
DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
Measured: 3 years

Secondary outcomes (3)

Overall Survival
OS is defined as time to death from any cause.
Measured: 3 years
Objective Response Rate (ORR)
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: 3 years
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: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2021Jun 2024

First posted6 Aug 2020
Study startJun 2021 (estimated)
Primary completionJun 2023 (estimated)
Study completionJun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04502680
Sponsor's protocol ID: EMBRAVE-001
Acronym: EMBRAVE-001
Status last verified: Aug 2020
First submitted: 4 Aug 2020
Last updated: 11 Aug 2020
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 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Maintenance Treatment With Eribulin Mesylate Following Standard Adjuvant Chemotherapy in Triple Negative Breast Cancer Patients
ClinicalTrials.gov ID: NCT04502680
Acronym / sponsor ID: EMBRAVE-001 / EMBRAVE-001
Conditions: Triple Negative Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: Jun 2021 (estimated)
Primary completion: Jun 2023 (estimated)
Study completion: Jun 2024 (estimated)
First posted: 6 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Eribulin Mesylate	Experimental	Drug: Eribulin MesylatePatients receive eribulin mesylate following standard adjuvant chemotherapy.
Observation	No intervention	–Observation. No intervention.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

The patient volunteers and signs an informed consent form;
Age ≥18 years old, female;
The patient was diagnosed as triple-negative breast cancer by histopathology (ER negative (IHC ER positive percentage <1%), PR negative (IHC PR positive percentage <1%), HER2 negative (IHC-/+ or IHC++ but FISH/CISH- )), and there is no evidence of metastasis;
Patients underwent radical or breast conserving surgery combined with sentinel lymph node biopsy for primary breast cancer. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
For patients who have previously received neoadjuvant therapy for triple-negative breast cancer containing anthracyclines and taxanes, the postoperative efficacy evaluation did not reach pathological complete remission (non-PCR), that is, the primary breast and/or metastatic regional lymph nodes still have histological evidence of malignant tumors other than carcinoma in situ;

Key exclusion criteria (8 listed)

Patients with metastatic breast cancer (including contralateral axillary lymph nodes), inflammatory carcinomas;
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;

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

Primary outcome

Disease Free Survival (DFS)
Time frame: 3 years
DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.

3 secondary outcomes

Overall Survival
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 3 years
The Number of Participants Who Experienced Adverse Events (AE)
Time frame: 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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.

Wei Li contact

Yongmei Yin contact

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 in people with Triple 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 16 inclusion and 8 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 11 Aug 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 Wei Li (13851603656, real.lw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502680.

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 11 Aug 2020.