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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.

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic Complete Response Rate

Secondary outcome measures

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

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

~2700

Adriamycin

2015

Completed Phase 4

~5820

Cyclophosphamide

1995

Completed Phase 3

~3780

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,850 Total Patients Enrolled

142 Trials studying Breast Cancer

22,617 Patients Enrolled for Breast Cancer

Eisai Inc.Industry Sponsor

515 Previous Clinical Trials

153,998 Total Patients Enrolled

17 Trials studying Breast Cancer

2,044 Patients Enrolled for Breast Cancer

Filipa Lynce, MDPrincipal InvestigatorDana-Farber Cancer Institute

5 Previous Clinical Trials

197 Total Patients Enrolled

4 Trials studying Breast Cancer

174 Patients Enrolled for Breast Cancer

Media Library

Adriamycin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02623972 — Phase 2

Breast Cancer Research Study Groups: Arm A: Eribulin > AC, Arm B: AC > Eribulin

Breast Cancer Clinical Trial 2023: Adriamycin Highlights & Side Effects. Trial Name: NCT02623972 — Phase 2

Adriamycin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02623972 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Eribulin pose any substantial risks to patients?

"As this is a Phase 2 trial, the safety of eribulin has been assessed as a 2 on our scale. This implies that there are some data points suggesting its safety, however no evidence verifying efficacy yet exist."

Answered by AI

Has Eribulin been utilized to run any other experimental studies?

"Currently, there are 982 Eribulin-oriented studies in progress. Of these trials, 203 have reached Phase 3. While the majority of those live research projects take place in Philadelphia, Pennsylvania, 35326 medical centres worldwide are running these investigations."

Answered by AI

Is recruitment currently taking place for this experiment?

"Sadly, the recruitment period for this clinical trial has concluded. The study went live on February 26th 2016 and was amended lastly in July 9th 2022. If you are seeking alternative trials, there is currently a total of 2285 studies actively looking to enrol patients with inflammatory breast cancer (ibc) and another 982 medical experiments searching for participants who have been prescribed Eribulin treatment."

Answered by AI

How many individuals are being tracked as part of this research endeavor?

"Currently, this trial is not actively seeking participation. Initially posted on February 26th 2016 and last edited on July 9th 2022, it has since been superseded by other clinical trials for inflammatory breast cancer (IBC) and Eribulin - of which 2285 and 982 respectively are currently recruiting patients."

Answered by AI

In what cases is Eribulin usually prescribed as a remedy?

"Eribulin is typically administered to those struggling with Kaposi's Sarcoma AIDS-related. However, it can also help in the management of leukemia, metastatic neoplasms, and advanced thymoma cases."

Answered by AI

Does this trial represent a pioneering approach to the issue?

"Currently, there are 982 active clinical trials involving eribulin running in 69 countries and 2350 cities. Since Alfacell kicked off the first study for this drug back in 1997 - which included 300 participants and was completed at Phase 3 of its approval process - 1488 more have been done since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Filipa Lynce, MD 2016. "A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02623972.

All > Inflammatory Breast Cancer