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Breast CancerPhase 2GIM9NCT00751868

FEC With G-CSF Support Followed by Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in BC

A Phase 2 study testing Ixabepilone in people with Breast Cancer, run by Consorzio Oncotech at 15 sites in Italy.

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 Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
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
47 participants
Where
15 sitesItaly
Study dates
Sep 2008to Jul 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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological documented diagnosis of breast cancer by incisional biopsy
  • Clinical T>=2
  • Females age >= 18 and <= 70 years
  • ECOG performance status 0-1
  • No prior treatment for breast cancer excluding therapy for DCIS
  • Subjects with hormone replacement therapy are eligible if this therapy is discontinued at least 2 weeks before starting therapy
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  • Neutrophils > 2x109/L, Hgb > 9 g/dL, platelets > 100x109/L
  • Total bilirubin < 1 time the upper limit of normal (ULN) of the Institutional normal values and AST and/or ALT < 2.5 ULN, alkaline phosphatase < 2.5 ULN
  • Serum creatinine < 1.5 times the upper limit of normal (ULN)
  • Normal cardiac function (normal ECG required in all patients, normal ECG and MUGA or Echocardiography with EF only in HER-2 positive patients)
  • Negative pregnancy test prior to inclusion in the study (if potentially childbearing)
  • Signed Informed consent

Who cannot join

  • Prior or current history of ipsilateral or controlateral breast invasive cancer. A past or current history of ipsilateral ductal carcinoma in situ or ipsilateral/controlateral lobular neoplasia in situ are not an exclusion criteria as well as a controlateral ductal carcinoma in situ removed by mastectomy
  • Inflammatory breast cancer
  • Metastatic breast cancer (M1)
  • Histology other than adenocarcinoma of the breast
  • Male patients
  • Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
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  • Patients unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational drug
  • History of prior or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
  • Symptomatic peripheral neuropathy > grade 1 according to the NCI CTC
  • Other serious illness or medical condition:
  • Congestive hearth failure or angina pectoris even if it is medically controlled. In particular, Ejection Fraction (EF) below the Institutional normal value for MUGA Fraction (EF) below the Institutional normal value for MUGA, or below 50% for ECHO
  • Previous history of myocardial infarction uncontrolled, high-risk ipertension or arrhythmia
  • History of significant neurological or psychiatric disorders including dementia or seizures
  • Active infection, active peptic ulcer, unstable diabetes mellitus or contraindications for the use of steroids
  • History of previous or concomitant malignancies other than curatively treated basal cell skin cancer or excised cervical carcinoma in situ
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry
  • Prior severe HSR to agents containing Cremophor EL

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Italy15 sites

  • Azienda Ospedaliera G. Rummo

    Benevento, BN, 82100

  • Ospedale Civile di Campobasso - A. Cardarelli

    Campabasso, CB, 86100

  • Azienda Ospedaliera Nesina Garibaldi

    Catania, CT, 95124

  • Azienda Ospedaliera S. Anna

    Como, CO, 22100

  • I.S.T. - Istituto Nazionale per la Ricerca sul Cancro

    Genova, GE, 16131

  • Ospedale civile Renzetti di Lanciano

    Lanciano, CH, 66034

  • Presidio Ospedaliero di Macerata

    Mecerata, MC, 62100

  • Ist. Nazionale per lo Studio e la Cura dei Tumori - Fondazione Pascale

    Naples, 80131

  • Università Federico II

    Naples, 80131

  • Ospedale S. Cuore Don Calabria

    Negrar, Verona, 37024

  • Azienda Ospedaliera R. Silvestrini

    Perugia, PG, 06132

  • Istituto Regina Elena

    Roma, Roma, 00100

  • Azienda Ospedaliera SS. Annunziata

    Sassari, SS, 07100

  • I.R.C.C.S. Multimedica - Casa di Cura Accreditata

    Sesto San Giovanni, Milano, 20099

  • Azienza Osped.Treviglio - Caravaggio

    Treviglio, BG, 24047

Other trials in Italy

About this study

Official title: NEO-ADIXERN (NEO-ADjuvant IXabepilone in Breast Cancer). A Feasibility Study of Dose-dense FEC With G-CSF Support Followed by Dose-dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in Breast Cancer

The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF.

To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.

Read the detailed description

Estrogen receptor negative breast cancer may be defined as distinct biologic subtype disease, more aggressive with a typical molecular portrait. [30] This subtype seems to have a poor prognosis and poor treatment options because these patients are not candidate to hormonal therapy. Novel treatment strategies focusing upon this subtype are necessary in the future. [31] There are reports of clinical benefit in estrogen receptor negative patients treated with dose-dense chemotherapy (see background CALGB 9741 and MIG-1 study). In the CALGB 9741 study, patients randomized to receive dose-dense regimens experienced severe toxicities during paclitaxel treatment leading to dose reduction in 7% and 5%respectively.

Ixabepilone has shown consistent activity and an acceptable safety profile in patients with all stages breast cancer. This phase II study evaluate the feasibility of dose-dense Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as neo-adjuvant treatment for ER-negative breast cancer patients.

Conditions
Breast Cancer
Being tested
Ixabepilone
Keywords
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.

  • IxabepiloneDrug

    Also called Ixempra

    Ixabepilone is administered as 3-hour intravenous infusion (iv) at the dose of 40 mg/mq, every 14 days for 4 cycles (with G-CSF support), sequentially to Fluorouracil 600 mg/mq as intravenous (iv) infusion, Epirubicin 90 mg/mq as intravenous (iv) bolus and Cyclophosphamide 600 mg/mq as intravenous (iv) infusion every 14 days for 4 cycles (with G-CSF support)

Study groups in NCT00751868
Study groupRoleWhat they receive
ARM 1ExperimentalFEC e Ixabepilone. A goal of 48 patients will be enrolled in this study by 16 Italian centres of the GIM (Gruppo Italiano Mammella) Group. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to be enrolled in the study
Receives: Drug: Ixabepilone

What is being measured

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

  1. Pathologic Complete Response (pCR)

    Measured: one year

Secondary outcomes (1)

  1. Feasibility/Tolerability for an individual patient is defined as the absence of hematologic toxicities requiring dose reduction as per protocol

    Measured: one year

Timeline

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

  1. First posted12 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00751868
Sponsor's protocol ID
GIM9-NEO-ADIXERN
Acronym
GIM9
Status last verified
Dec 2014
First submitted
11 Sep 2008
Last updated
17 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Clavarezza M, Bordonaro R, Daniele B, Ferrandina G, Barni S, Turazza M, Coati F, De Matteis A, De Placido S, Cognetti F, Olmeo NA, Carrozza F, Bruzzi P, Del Mastro L; Gruppo Italiano Mammella. Dose-dense FEC followed by dose-dense ixabepilone as neoadjuvant treatment for breast cancer patients: a feasibility study. Oncologist. 2013;18(8):924-5. doi: 10.1634/theoncologist.2013-0222. Epub 2013 Aug 12.

    PubMed 23939283

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixabepilone in people with Breast Cancer, run by Consorzio Oncotech at 15 sites in Italy.

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 12 inclusion and 17 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Complete Response (pCR) (time frame: one year). 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 NCT00751868, 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 17 Dec 2014.

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