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

NCT04502680 | Unknown Phase 2 FDA Drug

• 1 other identifier: EMBRAVE-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• Overall Survival

  3 years

• Objective Response Rate (ORR)

  3 years

• The Number of Participants Who Experienced Adverse Events (AE)

  3 years

Study Arms (2)

Eribulin Mesylate

EXPERIMENTAL

Patients receive eribulin mesylate following standard adjuvant chemotherapy.

Drug: Eribulin Mesylate

Observation

NO INTERVENTION

Observation. No intervention.

Interventions

Eribulin Mesylate DRUG

Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.

Also known as: Halaven

Eribulin Mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wei Li

CONTACT

13851603656; real.lw@163.com

Yongmei Yin

CONTACT

13951842727; ymyin@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)