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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 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
9%
Back pain
9%
Dysgeusia
8%
Musculoskeletal pain
8%
Paraesthesia
8%
Malaise
7%
Alanine aminotransferase increased
7%
Weight decreased
7%
Musculoskeletal chest pain
7%
Haemoptysis
6%
Arthralgia
6%
Aspartate aminotransferase increased
6%
Insomnia
6%
Productive cough
6%
Abdominal Pain Upper
6%
Rash
5%
General physical health deterioration
5%
Upper respiratory tract infection
5%
Abdominal Pain
5%
Pain in extremity
5%
Muscle Spasms
5%
Muscular Weakness
5%
Dizziness
4%
Pneumonia
1%
Lung infection
1%
Neutropenic sepsis
1%
Hypercalcaemia
1%
Confusional state
1%
Non-cardiac chest pain
1%
Febrile neutropenia
1%
Myocardial ischaemia
1%
Respiratory tract infection
1%
Metastases to central nervous system
1%
Metastatic pain
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
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
~2690
Adriamycin
2015
Completed Phase 4
~5820
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,908 Total Patients Enrolled
142 Trials studying Breast Cancer
22,620 Patients Enrolled for Breast Cancer
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
159,011 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
~2 spots leftby May 2025
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