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

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

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

Conditions: HER-2 Positive Breast Cancer
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 group	Role	What they receive
Eribulin, carboplatin, and trastuzumab	Experimental	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. Receives: Drug: eribulin; Drug: carboplatin; Drug: trastuzumab

What is being measured

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

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)

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.

Aug 2011Sep 2014

First posted7 Jul 2011 (estimated)
Study startAug 2011
Primary completionJun 2014
Study completionSep 2014

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HER-2 Positive Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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