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Estrogen Receptor-negative Breast CancerPhase 2NCT01372579

Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

A Phase 2 study testing eribulin mesylate, carboplatin and biopsy in people with Estrogen Receptor-negative Breast Cancer and HER2-negative Breast Cancer, run by Northwestern University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
eribulin mesylate, carboplatin and biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Aug 2011to Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed breast cancer; diagnosis must be reviewed and confirmed by the pathology department at Northwestern Memorial Hospital prior to registration on study, and all biopsy materials need to be reviewed and available for correlative studies
  • Patients must have stage I-III breast cancer
  • Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or fluorescent in situ hybridization (FISH) < ratio of 1.8
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) by mammogram, ultrasound or physical exam
  • Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of one year
  • Patients must have a life expectancy of > 12 weeks
Show all 17Show fewer
  • Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
  • Leukocytes >= 3,000/ul
  • Absolute neutrophil count >= 1,500/ul
  • Platelets >= 100,000/ul
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
  • Creatinine: within normal institutional limits
  • OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine levels above institutional normal
  • Women of childbearing potential must commit to the use of effective contraception while on study
  • Eligibility of patients receiving medications of substances known to affect, or with the potential to affect, the activity or pharmacokinetics of eribulin will be determined following review of their use by the Principal Investigator
  • All patients must have given signed, informed consent prior to registration on study

Who cannot join

  • Prior chemotherapy, immunotherapy or hormonal therapy for breast cancer is NOT allowed
  • Concomitant radiotherapy is NOT allowed
  • Patients may NOT be receiving any other investigational agents or concurrent anticancer therapies; in addition, use of any herbal (alternative) medicines is NOT permitted
  • Patients with uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations what would limit compliance with study requirements are NOT eligible to participate
  • Women who are pregnant or lactating are NOT eligible to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Phase II Neoadjuvant Trial With Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the pathologic complete response rate (pCR) at the time of definitive surgery.

SECONDARY OBJECTIVES:

  1. Determination of the clinical response rate, as measured by clinical exam and imaging studies prior to initiation of therapy and prior to surgery.

II. Measurement of alpha B-crystalline in tissue obtained before initiation of therapy and at the time of definitive surgery.

III. Stem cell markers (cluster of differentiation [CD]44+, CD24-, CD133, aldehyde dehydrogenase 1 [ALDH1] and evaluation of the NOTCH pathway) in tissue obtained before initiation of therapy and at the time of definitive surgery.

IV. Measurement of proliferation markers (Ki67) before and after treatment in tissue obtained before imitation of therapy and at the time of definitive surgery.

  1. Measurement of beta III tubulin in tissue obtained before initiation of therapy and at the time of definitive surgery.

VI. Measurement of Tau in tissue obtained before initiation of therapy and at the time of definitive surgery.

VII. Safety evaluation, including following of patients for alopecia and neuropathy.

VIII. Epidermal growth factor receptor (EGFR) staining before and after treatment in tissue obtained before initiation of therapy and at the time of definitive surgery.

OUTLINE:

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.

Being tested
eribulin mesylate, carboplatin, biopsy
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • eribulin mesylateDrug

    Also called Halaven, B1939, E7389, ER-086526

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • biopsyProcedure or surgery

    Also called biopsies

    Correlative studies

Study groups in NCT01372579
Study groupRoleWhat they receive
Treatment (neoadjuvant chemotherapy)ExperimentalPatients receive eribulin mesylate IV over 2-5 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: eribulin mesylate; Drug: carboplatin; Procedure: biopsy

What is being measured

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

  1. To determine the pathologic complete response rate (pCR).

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

Secondary outcomes (8)

  1. Measurement of alpha B-crystalline in tissue obtained

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

  2. Stem cell markers (CD44+, CD24-, CD133, ALDH1 and evaluation of the NOTCH pathway) in tissue

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

  3. Measurement of proliferation markers (Ki67)

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

  4. Measurement of beta III tubulin in tissue

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

  5. Measurement of Tau in tissue

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

  6. Determination of the clinical response rate, as measured by clinical exam and imaging studies prior to initiation of therapy and prior to surgery.

    Measured: Imaging studies at baseline and at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

  7. Safety profile of this drug combination

    Measured: Symptom assessment prior to each cycle (approximately every 3 weeks) and until resolution 6 months after the last dose of study treatment

  8. EGFR staining before and after treatment

    Measured: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)

Timeline

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

  1. First posted14 Jun 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2021 (estimated)

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01372579
Sponsor's protocol ID
NU 10B07
Other IDs
NCI-2011-00600, STU00045038
Status last verified
May 2019
First submitted
1 Jun 2011
Last updated
7 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Kaklamani VG, Jeruss JS, Hughes E, Siziopikou K, Timms KM, Gutin A, Abkevich V, Sangale Z, Solimeno C, Brown KL, Jones J, Hartman AR, Meservey C, Jovanovic B, Helenowski I, Khan SA, Bethke K, Hansen N, Uthe R, Giordano S, Rosen S, Hoskins K, Von Roenn J, Jain S, Parini V, Gradishar W. Phase II neoadjuvant clinical trial of carboplatin and eribulin in women with triple negative early-stage breast cancer (NCT01372579). Breast Cancer Res Treat. 2015 Jun;151(3):629-38. doi: 10.1007/s10549-015-3435-y. Epub 2015 May 26.

    PubMed 26006067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing eribulin mesylate, carboplatin and biopsy in people with Estrogen Receptor-negative Breast Cancer and HER2-negative Breast Cancer, run by Northwestern University at 1 site 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 17 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

To determine the pathologic complete response rate (pCR). (time frame: Biopsy at baseline and tissue removed at time of surgery (after approximately 12 weeks of neoadjuvant therapy)). 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 NCT01372579, which also lists 1 linked publication.

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 7 Jun 2019.

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