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HER-2 Positive Breast CancerPhase 1/2NCT01388647

Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer

A Phase 1/2 study testing eribulin, carboplatin and trastuzumab in people with HER-2 Positive Breast Cancer, run by Vector Oncology at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the safety and efficacy of eribulin in combination with carboplatin and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor receptor (HER)2 positive and are clinically stage IIA to IIIB. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HER-2 Positive Breast Cancer
What is being tested?
eribulin, carboplatin and trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesUnited States
Study dates
Aug 2011to Sep 2014
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Females; 18 years of age or greater
  • Histologically proven invasive breast cancer
  • American Joint Committee on Cancer (AJCC) clinical stage IIA - IIIB
  • Tumor size greater than 10 millimeters
  • HER2 positive
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Estrogen receptor (ER) positive or negative
  • Ejection fraction greater than or equal to lower limit of normal for the institution by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
  • Less than or equal to Grade 1 neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • Planned lumpectomy or mastectomy
  • Eligible for radiation therapy
  • No prior treatment for invasive breast cancer
  • Adequate organ system function per protocol as determined within 7 days prior to first dose of study treatment
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study treatment and must agree to use adequate contraception methods during study treatment and for a minimum of 6 months following trastuzumab discontinuation
  • Female subjects who are lactating should discontinue nursing prior to the first dose of study treatment and should refrain from nursing throughout the treatment period

Who cannot join

  • Fine needle cytology only without other histologic evidence of invasive breast cancer
  • Inflammatory breast cancer
  • AJCC clinical stage T1a-b breast cancer (primary tumor less than or equal to 10 millimeters)
  • Evidence of metastatic disease
  • HER2 negative
  • Ejection fraction less than lower limit of normal for the institution by ECHO or MUGA
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  • Corrected QT interval greater than 480 milliseconds
  • Pre-existing cardiac dysfunction
  • Prior history of invasive cancer within the past 3 years
  • Synchronous bilateral breast cancer
  • Pre-existing CTCAE v4.0 Grade 2 or greater neuropathy
  • Hypersensitivity to halichondrin B or halichondrin B chemical derivative
  • History of severe allergic reactions to cisplatin or other platinum containing compounds, or mannitol
  • Mild, moderate, or severe hepatic impairment
  • Moderate or severe renal impairment
  • Hypokalemia or hypomagnesemia if it cannot be corrected prior to the first dose of study treatment
  • Organ allografts requiring immunosuppression
  • Known positive human immunodeficiency virus (HIV) status
  • Prior major surgery within 28 days prior to the first dose of study treatment and/or presence of any non-healing wound, fracture, or ulcer
  • Minor surgery or radiation therapy within 14 days prior to the first dose of study treatment
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Northeast Georgia Cancer Care

    Athens, Georgia, 30607

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

Other trials in United States

About this study

Official title: Phase I/II Study of Neoadjuvant Carboplatin, Eribulin Mesylate and Trastuzumab (ECH) for Operable HER2 Positive Breast Cancer

This study will evaluate the safety and efficacy of eribulin in combination with carboplatin and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor receptor (HER)2 positive and are clinically stage IIA to IIIB.

The study regimen will be administered every 3 weeks for a total of 6 cycles followed by definitive surgery.

Read the detailed description

During Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle. Carboplatin area under the curve (AUC) 6 will be administered IV over 15 to 30 minutes on Day 1 of each cycle. Trastuzumab will be administered as an IV infusion on Day 1 of each cycle. A loading dose of 8 mg/kg of trastuzumab will be administered over 90 minutes on Cycle 1 Day 1. Then, a maintenance dose of 6 mg/kg of trastuzumab will be administered over 30 to 90 minutes on Day 1 of Cycles 2 - 6.

eribulin: During Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle.

carboplatin: Carboplatin area under the curve

Being tested
eribulin, carboplatin, trastuzumab
Keywords
Neoadjuvant Treatment, HER-2 Positive Breast Cancer

What participants receive

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

  • eribulinDrug

    Also called eribulin mesylate, HALAVEN

    During Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle.

  • carboplatinDrug

    Carboplatin area under the curve (AUC) 6 will be administered IV over 15 to 30 minutes on Day 1 of each cycle.

  • trastuzumabDrug

    Also called Herceptin

    Trastuzumab will be administered as an IV infusion on Day 1 of each cycle. A loading dose of 8 mg/kg of trastuzumab will be administered over 90 minutes on Cycle 1 Day 1. Then, a maintenance dose of 6 mg/kg of trastuzumab will be administered over 30 to 90 minutes on Day 1 of Cycles 2 - 6.

Study groups in NCT01388647
Study groupRoleWhat they receive
Eribulin, carboplatin, and trastuzumabExperimentalDuring Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle. Carboplatin area under the curve (AUC) 6 will be administered IV over 15 to 30 minutes on Day 1 of each cycle. Trastuzumab will be administered as an IV infusion on Day 1 of each cycle. A loading dose of 8 mg/kg of trastuzumab will be administered over 90 minutes on Cycle 1 Day 1. Then, a maintenance dose of 6 mg/kg of trastuzumab will be administered over 30 to 90 minutes on Day 1 of Cycles 2 - 6.
Receives: Drug: eribulin; Drug: carboplatin; Drug: trastuzumab

What is being measured

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

  1. Pathologic Response

    Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).

    Measured: Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start

Secondary outcomes (1)

  1. Clinical Response

    Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (> 50% reduction in longest diameter of pretreatment tumor), no response (< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.

    Measured: Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.

Timeline

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

  1. First posted7 Jul 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2014
  4. Study completionSep 2014

Why it stopped: Closed early due to increased hematologic toxicity and possible reduced efficacy

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01388647
Sponsor's protocol ID
ALSSNBC1006
Status last verified
Dec 2014
First submitted
5 Jul 2011
Last updated
28 Aug 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing eribulin, carboplatin and trastuzumab in people with HER-2 Positive Breast Cancer, run by Vector Oncology at 4 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 16 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 28 Aug 2015). 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?

Pathologic Response (time frame: Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start). 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 NCT01388647.

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 28 Aug 2015.

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