Study Summary
This trial is testing a new drug to see if it can help treat HER2 negative inflammatory breast cancer.
Eligible Conditions
- Inflammatory Breast Cancer
- Triple Negative Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: 2 Years
112 Days
Pathologic Complete Response
2 Years
Pathologic disease response at mastectomy will be reported as "residual disease burden (RCB)".
Week 20
Residual Cancer Burden (RCB)
Week 20
Pathologic Complete Response Rate
Year 5
Disease Free Survival
Year 5
Overall Survival
Year 5
Time to Treatment Failure
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Arm A: Eribulin Mesylate
36%Decreased appetite
34%Neutropenia
30%Alopecia
27%Nausea
25%Fatigue
23%Constipation
22%Asthenia
22%Anaemia
22%Neutrophil count decreased
21%Dyspnoea
20%White blood cell count decreased
17%Pyrexia
16%Peripheral sensory neuropathy
16%Cough
16%Stomatitis
15%Oedema peripheral
14%Diarrhoea
13%Headache
11%Vomiting
10%Myalgia
10%Leukopenia
9%Dysgeusia
9%Back pain
8%Paraesthesia
8%Malaise
8%Musculoskeletal pain
7%Haemoptysis
7%Alanine aminotransferase increased
7%Weight decreased
7%Musculoskeletal chest pain
6%Abdominal Pain Upper
6%Rash
6%Aspartate aminotransferase increased
6%Arthralgia
6%Productive cough
6%Insomnia
5%Dizziness
5%Abdominal Pain
5%Muscle Spasms
5%Upper respiratory tract infection
5%Muscular Weakness
5%Pain in extremity
5%General physical health deterioration
4%Pneumonia
1%Lung infection
1%Febrile neutropenia
1%Hypercalcaemia
1%Chronic obstructive pulmonary disease
1%Pleural effusion
1%Pulmonary embolism
1%Non-cardiac chest pain
1%Metastatic pain
1%Confusional state
1%Metastases to central nervous system
1%Myocardial ischaemia
1%Neutropenic sepsis
1%Respiratory tract infection
Trial Design
2 Treatment Groups
Arm B: AC > Eribulin
1 of 2
Arm A: Eribulin > AC
1 of 2
Experimental Treatment
22 Total Participants · 2 Treatment Groups
Primary Treatment: Eribulin · No Placebo Group · Phase 2
Arm B: AC > EribulinExperimental Group · 3 Interventions: Eribulin, Cyclophosphamide, Adriamycin · Intervention Types: Drug, Drug, Drug
Arm A: Eribulin > ACExperimental Group · 3 Interventions: Eribulin, Cyclophosphamide, Adriamycin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eribulin
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,016 Previous Clinical Trials
393,776 Total Patients Enrolled
Eisai Inc.Industry Sponsor
506 Previous Clinical Trials
145,037 Total Patients Enrolled
Filipa Lynce, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
33 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a platelet count of at least 100,000/mcL.
Breast cancer patients who have had a mastectomy for invasive breast cancer are eligible for this study.
You have a performance status of 1 or 2.
AST/ALT ratio > 2.5 or institutional upper limit of normal creatinine > 1.5 or both.
Patients must NOT have HER2 positive status based on ASCO/CAP guidelines defined as: IHC 3+ based on circumferential membrane staining that is complete, intense and/or Single-probe average HER2 copy number ≥ 6.
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Conditions
Cancer Related
Treatments