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Active, not recruitingNCT02623972Updated Jul 6, 2026Results posted

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

A Phase 2 interventional study of Eribulin and Adriamycin in Inflammatory Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, sponsored by Dana-Farber Cancer Institute. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This research study is studying a drug called eribulin combined with standard treatment as a possible preoperative treatment for HER2 negative inflammatory breast cancer.

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

Eribulin works by interfering with cancer cell division, growth, and spread.

The goal of this research study is to evaluate inflammatory breast cancer's response to treatment with eribulin followed by AC chemotherapy (Cohort A) and also the response to treatment with AC followed by Eribulin (Cohort B) when given as a preoperative chemotherapy treatment for participants with HER2 negative inflammatory breast cancer.

02

Conditions studied

  • Inflammatory Breast Cancer
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Keywords

  • inflammatory breast cancer
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
03

In context

Inflammatory Breast Neoplasms

84 studies on the registry are indexed under Inflammatory Breast Neoplasms; 7 are open to participants now.

This study's enrollment of 22 is below the median of 54 across 74 interventional studies indexed under Inflammatory Breast Neoplasms.

Browse Inflammatory Breast Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Participants must have histologically confirmed invasive breast cancer. All histologic subtypes are eligible.

-- 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

FISH positive based on one of the three following criteria:

Single-probe average HER2 copy number ≥ 6.0 signals/cell; OR Dual-probe HER2/CEP17 ratio \<2.0 with an average HER2 copy number ≥ 6.0 signals/cell; OR Dual-probe HER2/CEP17 ratio ≥2.0

  • Age ≥18 years. Because no dosing or adverse event data are currently available on the use of eribulin in participants \<18 years of age, children are excluded from this study
  • 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.
  • Patients must have the clinical diagnosis of inflammatory breast cancer.
  • Patients must be without evidence of visceral or bone involvement with metastatic cancer on physical exam or any diagnostic study. Extensive nodal involvement (distant or regional) is allowed.
  • LVEF > 50% calculated by echocardiogram (ECHO)
  • Patients may have bilateral breast cancer so long as one breast meets criteria for inflammatory breast cancer, and the breast with inflammatory breast cancer has never received prior therapy.
  • The effects of eribulin on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Both men and women of all races and ethnic groups are eligible for this trial. Because breast cancer predominantly affects females, it is anticipated that male enrollment will be \< 5% of the overall study population.

Exclusion criteria

Exclusion Criteria:

  • Participants who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to eribulin or other agents used in study.
  • 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.
  • Pregnant women are excluded from this study because eribulin is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eribulin, breastfeeding should be discontinued if the mother is treated with eribulin. These potential risks may also apply to other agents used in this study.
  • HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with eribulin. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
  • A baseline corrected QT interval of > 470 ms.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • Patients may not have received eribulin, paclitaxel, doxorubicin, or cyclophosphamide as anti-neoplastic therapy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Arm A: Eribulin > AC

    * 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

    Drug: Eribulin · Drug: Adriamycin · Drug: Cyclophosphamide

  • Experimental
    Arm B: AC > Eribulin

    * 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

    Drug: Eribulin · Drug: Adriamycin · Drug: Cyclophosphamide

Interventions

  • DrugEribulin

    administered IV for 4 cycles

    Also known as: Halaven, B1939 mesylate

  • DrugAdriamycin

    administered IV with cyclophosphamide for 4 cycles

    Also known as: Doxorubicin

  • DrugCyclophosphamide

    administered IV with adriamycin for 4 cycles

    Also known as: Cytoxan®, Neosar®

06

What researchers measure

Primary outcomes

  1. Pathologic Complete Response Rate

    Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.

    Time frame: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks.

Secondary outcomes

  1. Disease Free Survival

    Disease-free survival (DFS) is defined for the participants who undergo surgery, as the duration of time from surgery until ipsilateral local-regional, contralateral or distant invasive recurrence or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from recurrence.

    Time frame: 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.

  2. Time to Treatment Failure

    Time to treatment failure (TTF) will be defined among all participants, as the duration of time from treatment initiation to a DFS event or progressive disease during preoperative therapy or treatment disease that is not surgically resectable; in the absence of an event, TTF will be censored at the date last know alive and free from recurrence or progression.

    Time frame: TTF 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 TTF measurement duration is anticipated to last for at least 5 years.

  3. Overall Survival

    Overall Survival (OS) will be defined two ways: among patients who undergo surgery, as time from surgery until death from any cause; and among all patients, as the time from treatment initiation until death from any cause. Censoring will use the date last known alive.

    Time frame: 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.

  4. Residual Cancer Burden (RCB)

    Residual cancer burden is calculated and then categorized based on level of residual disease after neoadjuvant therapy and several other factors as assessed by pathologists. This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III.(RCB category "Unknown" if unable to determine RCB or missing data.) The previous categories are in order of increasing severity of RCB. Measurement of residual breast cancer burden can predict survival after neoadjuvant chemotherapy.

    Time frame: Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks.

07

Results

Posted Dec 28, 2022

Participant flow

February 2016 to December 2020

Participant flow — Overall Study
MilestoneArm A: Eribulin Followed by ACArm B: AC Followed by Eribulin
Started166
Completed166
Not completed00

Outcome measures

PrimaryPathologic Complete Response Rate

Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.

Time frame:
Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks.
Reported as:
Number · percentage of participants
Pathologic Complete Response Rate
percentage of participantsArm A: Eribulin Followed by ACArm B: AC Followed by Eribulin
Pathologic Complete Response Rate6.25 (0.66 to 22.22)0 (0 to 31.87)
Statistical analysis
  • Arm A: Eribulin Followed by AC · Simon minimax two-stage design · Pathelogic complete response rate: 30Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 10% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 30% then the regimen is worthy of further study.
  • Arm B: AC Followed by Eribulin · Simon minimax two-stage design · Pathelogic complete response rate: 23Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 2% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 23% then the regimen is worthy of further study.
SecondaryDisease Free Survival

Disease-free survival (DFS) is defined for the participants who undergo surgery, as the duration of time from surgery until ipsilateral local-regional, contralateral or distant invasive recurrence or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from recurrence.

Time frame:
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.

Results for this outcome have not been posted.

SecondaryTime to Treatment Failure

Time to treatment failure (TTF) will be defined among all participants, as the duration of time from treatment initiation to a DFS event or progressive disease during preoperative therapy or treatment disease that is not surgically resectable; in the absence of an event, TTF will be censored at the date last know alive and free from recurrence or progression.

Time frame:
TTF 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 TTF measurement duration is anticipated to last for at least 5 years.

Results for this outcome have not been posted.

SecondaryOverall Survival

Overall Survival (OS) will be defined two ways: among patients who undergo surgery, as time from surgery until death from any cause; and among all patients, as the time from treatment initiation until death from any cause. Censoring will use the date last known alive.

Time frame:
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.

Results for this outcome have not been posted.

SecondaryResidual Cancer Burden (RCB)

Residual cancer burden is calculated and then categorized based on level of residual disease after neoadjuvant therapy and several other factors as assessed by pathologists. This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III.(RCB category "Unknown" if unable to determine RCB or missing data.) The previous categories are in order of increasing severity of RCB. Measurement of residual breast cancer burden can predict survival after neoadjuvant chemotherapy.

Time frame:
Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks.
Reported as:
Number · percentage of participants
Residual Cancer Burden (RCB)
percentage of participantsArm A: Eribulin Followed by ACArm B: AC Followed by Eribulin
RCB-06.25 (0.66 to 22.22)0 (0 to 31.87)
RCB-I12.5 (3.37 to 29.96)0 (0 to 31.87)
RCB-II25 (11.38 to 43.89)50 (20.09 to 79.91)
RCB-III56.25 (37.5 to 73.71)33.33 (9.26 to 66.68)
Unknown0 (0 to 13.4)16.67 (1.74 to 51.03)

Adverse events

Collected over All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A: Eribulin Followed by AC1/16 (6.3%)5/16 (31.3%)16/16 (100%)
Arm B: AC Followed by Eribulin0/6 (0%)1/6 (16.7%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventArm A: Eribulin Followed by ACArm B: AC Followed by Eribulin
Neutrophil count decreasedInvestigations4/161/6
AnemiaBlood and lymphatic system disorders1/160/6
Lung infectionInfections and infestations1/160/6
Alanine aminotransferase increasedInvestigations1/160/6
Aspartate aminotransferase increasedInvestigations1/160/6
PneumonitisRespiratory, thoracic and mediastinal disorders1/160/6
Most frequent other events
Showing 10 of 74
Most frequent other events
EventArm A: Eribulin Followed by ACArm B: AC Followed by Eribulin
FatigueGeneral disorders and administration site conditions15/166/6
NauseaGastrointestinal disorders10/165/6
Alanine aminotransferase increasedInvestigations6/164/6
Aspartate aminotransferase increasedInvestigations6/164/6
HeadacheNervous system disorders7/164/6
AlopeciaSkin and subcutaneous tissue disorders10/164/6
Peripheral sensory neuropathyNervous system disorders6/163/6
ConstipationGastrointestinal disorders6/161/6
DiarrheaGastrointestinal disorders4/162/6
PainGeneral disorders and administration site conditions2/162/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
Median57 (35 to 64)59 (37 to 72)58 (35 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
Female16622
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
Hispanic or Latino000
Not Hispanic or Latino16622
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White16521
More than one race011
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
United States16622
Estrogen Receptor Status
Estrogen Receptor Status(Participants)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
<1%303
1-10%011
>10%13518
Breast Cancer Stage
Breast Cancer Stage(Participants)Arm A: Eribulin Followed by ACArm B: AC Followed by EribulinTotal
Unknown011
IIIB14317
IIIC213
IV011
08

Study locations

2 sites
  • Brigham and Women's Hospital
    Boston, Massachusetts 02215, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
09

References and documents

Publications

  • Fanucci K, Yeh ED, Shi R, Qin L, Bay CP, DiLullo M, Patel A, Moore M, Herbert ZT, Harrison BT, Nakhlis F, Bellon J, Warren L, Guerriero JL, Tolaney SM, Regan M, Overmoyer B, Van Laere S, Lynce F. Neoadjuvant therapy with eribulin, doxorubicin and cyclophosphamide for patients with HER2-negative inflammatory breast cancer: a phase II study. Breast Cancer Res. 2025 Sep 29;27(1):171. doi: 10.1186/s13058-025-02108-4. PubMed 41024110 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 23, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02623972
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Eisai Inc.
Responsible party
Filipa Lynce, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Dec 8, 2015
Start date
Feb 26, 2016
Primary completion
May 2021
Completion
Dec 2026 (estimated)
Results posted
Dec 28, 2022
Last update
Jul 6, 2026

Study contacts

Filipa Lynce, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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