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Alkylating Agent

Eribulin + AC Chemotherapy for Breast Cancer

Phase 2

Waitlist Available

Led By Filipa Lynce, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤1 (Karnofsky ≥70%)

Participants must have normal organ and marrow function as defined below: leukocytes ≥3,000/mcL, absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, creatinine ≤1.5 × institutional upper limit of normal, or creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

HIV-positive participants on combination antiretroviral therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up os is assessed every cycle for 8 cycles. after protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. the os measurement duration is anticipated to last for at least 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can help treat HER2 negative inflammatory breast cancer.

Who is the study for?

This trial is for adults over 18 with HER2-negative inflammatory breast cancer, no prior therapy for one affected breast, and no metastatic cancer in organs or bones. Participants need normal heart function and organ/marrow health, must not be pregnant or breastfeeding, agree to use contraception, and have no severe illnesses that could affect study participation.

What is being tested?

The study tests eribulin combined with standard chemotherapy drugs Adriamycin (doxorubicin) and Cyclophosphamide as a preoperative treatment. It aims to evaluate the effectiveness of this drug combination in treating patients before they undergo surgery for their breast cancer.

What are the potential side effects?

Potential side effects include reactions similar to allergic responses, heart issues like QT interval prolongation (a type of irregular heartbeat), blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, fatigue, nausea, hair loss from chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to carry out my daily activities.

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My blood tests show my organs are functioning well.

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I have been diagnosed with inflammatory breast cancer.

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My breast cancer diagnosis was confirmed through a biopsy.

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I am 18 years old or older.

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My cancer has not spread to my organs or bones, but may be in many lymph nodes.

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My cancer is not HER2 positive according to specific guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am HIV-positive and on combination antiretroviral therapy.

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I have not been treated with eribulin, paclitaxel, doxorubicin, or cyclophosphamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dfs is assessed every cycle for 8 cycles. after protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.the dfs measurement duration is anticipated to last for at least 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dfs is assessed every cycle for 8 cycles. after protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.the dfs measurement duration is anticipated to last for at least 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and dfs is assessed every cycle for 8 cycles. after protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.the dfs measurement duration is anticipated to last for at least 5 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Complete Response Rate

Secondary study objectives

Disease Free Survival

Overall Survival

Residual Cancer Burden (RCB)

+1 more

Side effects data

From 2016 Phase 3 trial • 540 Patients • NCT01454934

36%

Decreased appetite

34%

Neutropenia

30%

Alopecia

27%

Nausea

25%

Fatigue

23%

Constipation

22%

Neutrophil count decreased

22%

Anaemia

22%

Asthenia

21%

Dyspnoea

20%

White blood cell count decreased

17%

Pyrexia

16%

Stomatitis

16%

Cough

16%

Peripheral sensory neuropathy

15%

Oedema peripheral

14%

Diarrhoea

13%

Headache

11%

Vomiting

10%

Leukopenia

10%

Myalgia

Back pain

Dysgeusia

Musculoskeletal pain

Paraesthesia

Malaise

Alanine aminotransferase increased

Weight decreased

Musculoskeletal chest pain

Haemoptysis

Arthralgia

Aspartate aminotransferase increased

Insomnia

Productive cough

Abdominal Pain Upper

Rash

General physical health deterioration

Upper respiratory tract infection

Abdominal Pain

Pain in extremity

Muscle Spasms

Muscular Weakness

Dizziness

Pneumonia

Lung infection

Neutropenic sepsis

Hypercalcaemia

Confusional state

Non-cardiac chest pain

Febrile neutropenia

Myocardial ischaemia

Respiratory tract infection

Metastases to central nervous system

Metastatic pain

Chronic obstructive pulmonary disease

Pleural effusion

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Eribulin Mesylate

Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: AC > EribulinExperimental Treatment3 Interventions

* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Group II: Arm A: Eribulin > ACExperimental Treatment3 Interventions

* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eribulin

2012

Completed Phase 3

~2740

Adriamycin

2015

Completed Phase 4

~5930