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Metastatic Breast CancerPhase 2HITNCT00790894

Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT)

A Phase 2 study testing ixabepilone in people with Metastatic Breast Cancer, run by Hellenic Cooperative Oncology Group at 13 sites in Greece.

Terminated

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

Official record
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Trial summary

This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to receive Ixabepilone either every three weeks… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
ixabepilone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
13 sitesGreece
Study dates
Nov 2008to May 2011
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Female patients aged 18 to 75 years inclusive
  • Prior chemotherapy in the adjuvant or neo-adjuvant setting
  • Diagnosis of HER-2 negative (HER-2 <2+ by immunohistochemistry and/or FISH negative) metastatic breast adenocarcinoma confirmed by the pathology department of the enrolling institution
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of at least 12 weeks
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  • Measurable disease by the Response Criteria in Solid Tumors (RECIST) method
  • Laboratory values within the specified ranges within 1 week of study enrolment:
  • Absolute neutrophil count of ≥ 1.5 x 109/L
  • Thrombocyte count of ≥ 100 x 109/L
  • Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease
  • Prior hormonal therapy for locally recurrent or metastatic disease allowed
  • AST and ALT ≤ 2.5 x ULN
  • Bilirubin ≤ 1.5 x ULN
  • Recovery from prior palliative radiotherapy for bone metastases

Who cannot join

  • Because of concerns that ixabepilone metabolism may be inhibited by potent cytochrome P450 3A4 inhibitors, patients must not receive the following medications, up to 72 hours prior to initiation of study therapy and until they come off treatment with ixabepilone: amprenavir, delavirdine, voriconazole, erythromycin, cyclosporine, troleandomycin, terfenadine, ketoconazole, nelfinavir, and ritonavir
  • Patients with CTC grade 2 or greater neuropathy at baseline
  • Patients with any history or evidence of brain an/or leptomenigneal metastasis
  • Patients with clinically significant cardiac disease (e.g. unstable angina, congestive heart failure, myocardial infarction) within 6 months from study entry
  • Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocol
  • Any concurrent active malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix (subjects with a history of previous malignancies but without evidence of disease for 5 years will be allowed to enter the trial)
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  • Prior severe HSR to agents containing Cremophor EL
  • Women of childbearing potential (WOCBP) who are unwilling or unable to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks from the last dose of ixabepilone, in such a manner that the risk of pregnancy is minimized WOCBP include: any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; women on hormone replacement therapy with documented FSH level > 35mIU/mL. Even women who are practising abstinence or whom their partner is sterile (e.g. vasectomy) should be considered of childbearing potential.
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrolment or prior to study therapy
  • No other concomitant chemotherapy, endocrine therapy, immunotherapy, radiation therapy (except for palliative radiotherapy for bone metastases) or investigational treatments are allowed during subject's participation in the study

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Greece13 sites

  • Hippokration General Hospital, Oncology Department

    Athens, 11527

  • University Hospital Attikon, Second Department of Internal Medicine, Oncology Section

    Athens, 12462

  • Agii Anargiri Cancer Hospital, Third Department of Medical Oncology

    Athens, 13122

  • Hygeia Hospital, First Deparment of Medical Oncology

    Athens, 15123

  • Hygeia Hospital, Second Department of Medical Oncology

    Athens, 15123

  • Alexandra Hospital, Department of Clinical Therapeutics

    Athens

  • University General Hospital of Ioannina, Medical Oncology Department

    Ioannina, 45500

  • University Hospital of Larisa, Department of Medical Oncology

    Larissa, 41110

  • University Hospital of Patras, Department of Medicine, Division of Oncology

    Pátrai, 265 00

  • Metropolitan Hospital, First Department of Medical Oncology

    Piraeus, 18547

  • Metropolitan Hospital, Second Dept of Medical Oncology

    Piraeus, 18547

  • "Theageneio" Cancer Hospital, Third Department of Medical Oncology

    Thessaloniki, 54007

  • "Papageorgiou" General Hospital, Department of Medical Oncology

    Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Phase II Randomized Trial of Ixabepilone Administered Weekly or Every Three Weeks in Patients With HER-2 Negative Metastatic Breast Cancer Previously Treated With Chemotherapy in the Neo-adjuvant or Adjuvant Setting

This is a Phase II Randomized, Open Label, Non-comparative Trial (Parallel Assignment and Efficacy Study) for patients with HER-2 Negative Metastatic Breast Cancer Previously Treated With chemotherapy in the Neo-Adjuvant or Adjuvant Setting.Patients will be randomized to receive Ixabepilone either every three weeks, or weekly for three weeks followed by one week off. Patients will be treated until consent withdrawal, intolerable toxicity or documented disease progression

Read the detailed description

Patients with measurable metastatic breast cancer that have been treated in the adjuvant or neo-adjuvant setting with chemotherapy will be considered for this study. Subjects must not have received cytotoxic chemotherapy for locally recurrent/metastatic disease. Patients who fulfil the eligibility criteria, and have signed inform consent for the trial will be centrally randomized by electronic means to one of two ixabepilone treatment arms. Stratification factors will include: time to recurrence from adjuvant treatment, calculated from the date of the last dose of adjuvant treatment to the date of relapse (≤ 1 year vs. > 1 year); and previous chemotherapy with taxane regimen in the neo-adjuvant or adjuvant setting (yes vs. no). Randomization will be balanced by site.Treatment Protocol· Arm A [standard once every three weeks schedule]:Ixabepilone [BMS-247550] will be administered on Day 1 (D1) every three weeks as a 3-hour infusion at a dose of 40 mg/m2. · Arm B [weekly schedule]:Ixabepilone [BMS-247550] will be administered weekly for three weeks as a 3-hour infusion at a dose of 20 mg/m2, followed by one week-off.Treatment can be continued until consent withdrawal by the patient, intolerable toxicity or documented disease progression.

Being tested
ixabepilone
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ixabepiloneDrug

    Arm A: ixabepilone will be given at a dose of 40 mg/m2 as a 3-hour intravenous infusion on Day 1 in a 21 days cycle.

  • ixabepiloneDrug

    Arm B: ixabepilone will be given at a dose of 20 mg/m2 as a 3-hour intravenous infusion on Days 1, 8 and 15, then 1 week off in a 28-days cycle.

Study groups in NCT00790894
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: ixabepilone
2ExperimentalNot described
Receives: Drug: ixabepilone

What is being measured

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

  1. The primary endpoint of the study is the best Overall Response (OR).

    Measured: At 6, 12 and 24 weeks

Secondary outcomes (3)

  1. Efficacy endpoints: time to response, PFS, TTF, duration of response

    Measured: Duration of the study

  2. OS Toxicity endpoints: incidence of hematological and non-hematological toxicities

    Measured: Duration of the study

  3. Translational endpoints

    Measured: Duration of the study

Timeline

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

  1. First posted14 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionApr 2011
  4. Study completionMay 2011

Why it stopped: The low accrual rate of the study (25% of the expected accrual rate)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790894
Sponsor's protocol ID
HE 11A08
Acronym
HIT
Status last verified
May 2011
First submitted
13 Nov 2008
Last updated
18 May 2011
Results posted
No
Data monitoring committee
No

Publications

  • Fountzilas G, Kotoula V, Pectasides D, Kouvatseas G, Timotheadou E, Bobos M, Mavropoulou X, Papadimitriou C, Vrettou E, Raptou G, Koutras A, Razis E, Bafaloukos D, Samantas E, Pentheroudakis G, Skarlos DV. Ixabepilone administered weekly or every three weeks in HER2-negative metastatic breast cancer patients; a randomized non-comparative phase II trial. PLoS One. 2013 Jul 23;8(7):e69256. doi: 10.1371/journal.pone.0069256. Print 2013.

    PubMed 23935969

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Metastatic Breast Cancer, run by Hellenic Cooperative Oncology Group at 13 sites in Greece.

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 15 inclusion and 11 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 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Greece. 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?

The study was stopped early (reason given: The low accrual rate of the study (25% of the expected accrual rate)). 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?

The primary endpoint of the study is the best Overall Response (OR). (time frame: At 6, 12 and 24 weeks). 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 NCT00790894, 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 18 May 2011.

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