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HER2-normalPhase 2NCT01328249

Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer

A Phase 2 study testing eribulin mesylate in people with HER2-normal, run by Eisai Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
HER2-normal
What is being tested?
eribulin mesylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
2 sitesUnited States
Study dates
3 Mar 2011to 19 Oct 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects aged greater than or equal to (>=) 18 years
  • Histologically confirmed Stage I to III invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.
  • HER-2 normal as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemistry (IHC) staining.
  • Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
  • Adequate cardiac function, defined by baseline LVEF >=50 percent (%) by Multiple Gated Acquisition (MUGA) scan or echocardiogram.
  • ECOG performance status of 0 or 1.
Show all 11Show fewer
  • Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 mg/dL or calculated creatinine clearance >=40 mL/min per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by ANC >=1.5 x 10^9/L, hemoglobin >=10.0 g/dL, and platelet count >=100 x 10^9/L.
  • Adequate liver function as evidenced by bilirubin <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 x ULN.
  • Females of childbearing potential must have a negative urine or beta-human chorionic gonadotropin serum pregnancy test within 2 weeks prior to Cycle 1, Day 1. A urine pregnancy test should be repeated prior to chemotherapy if not conducted within 72 hours of start of treatment. Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male subjects who are not abstinent or who have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
  • Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice.

Who cannot join

  • Stage IV breast cancer.
  • Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.
  • Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.
  • Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer.
  • Subjects with known positive human immunodeficiency virus (HIV) status.
  • Pregnancy or breast feeding at the time of study enrollment. Eligible subjects of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy.
  • Subjects with known allergy or hypersensitivity to doxorubicin, cyclophosphamide, or eribulin mesylate.
  • Inability to comply with the study and/or follow-up procedures.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dartmouth-Hitchcock Medical Center ,Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II, Single-Arm, Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer

The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.

Read the detailed description

This is a multicenter, single-arm Phase II trial to assess the feasibility of dose-dense adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A total of 80 adult subjects will be enrolled in order to have 73 subjects who start the eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle.

Conditions
HER2-normal
Being tested
eribulin mesylate
Keywords
Breast Cancer, HER2-normal Stage I to III invasive breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eribulin mesylateDrug

    Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks.

Study groups in NCT01328249
Study groupRoleWhat they receive
Doxorubicin and cyclophosphamide followed by eribulin mesylateExperimentalNot described
Receives: Drug: eribulin mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Feasibility

    The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.

    Measured: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months

Secondary outcomes (1)

  1. Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs)

    Safety assessments consisted of monitoring and recording all AEs and SAEs, clinical laboratory results, vital signs, physical examinations, Eastern Cooperative Oncology Group (ECOG) performance status, electrocardiograms (ECGs), and left-ventricular ejection fracture (LVEF) by multigated acquisition scan (MUGA) or echocardiogram. An AE was considered a treatment emergent adverse event (TEAE) if the AE onset date was on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related TEAEs included TEAEs that were considered by the Investigator to be possibly or probably related to eribulin mesylate and/or doxorubicin/cyclophosphamide, or missing causality. Standardized Medical Dictionary for Regulatory Activities Queries (SMQ).

    Measured: From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study start3 Mar 2011
  3. Primary completion27 Oct 2014
  4. Study completion19 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328249
Sponsor's protocol ID
E7389-A001-210
Status last verified
Mar 2018
First submitted
22 Mar 2011
Last updated
20 Aug 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing eribulin mesylate in people with HER2-normal, run by Eisai Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Feasibility (time frame: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01328249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.

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