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Breast CancerPhase 2ELBANCT01005641

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

A Phase 2 study testing exemestane and lapatinib in people with Breast Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Aromatase inhibitors are the standard treatment for hormone responsive advanced breast cancer. The combination of the aromatase inhibitor exemestane with with another breast cancer drug that blocks epidermal growth factor receptor (EGFR) and Erb-2 activity (lapatinib) is being studied for the possibility of improving… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Cancer
What is being tested?
exemestane and lapatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesItaly
Study dates
Dec 2009to Mar 2012
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histological diagnosis of breast cancer
  • Indication for hormonal therapy (ER and/or PgR positive)
  • Stage IV disease
  • Female gender
  • Postmenopausal status (patients treated with LHRH analogs are eligible for the Phase II part of the study)
  • At least one target or non-target lesion according to RECIST criteria
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  • ECOG Performance Status 0-2
  • Adequate bone marrow (neutrophils > or = 1.500/mm³, platelets > or = 100.000/mm³ and hemoglobin > or = 9 g/dl), hepatic (GOT, GPT < 2.5 e bilirubin <1.25 times the value of upper normal limit) and renal (creatinine < 1.25 times the value of upper normal limit) function
  • Adequate cardiac function (FEVS > or = 50%)
  • Able to take oral medications
  • Life expectancy > 3 months
  • Signed informed consent

Who cannot join

  • Any previous hormone therapy for metastatic disease
  • More than one line of chemotherapy for metastatic disease (first line chemotherapy is permitted)
  • Symptomatic cerebral metastases
  • Planned concomitant radiation therapy in the first month of therapy (for those patients participating in the dose finding phase of the study)
  • Previous therapy with exemestane, including as adjuvant therapy (previous therapy with non-steroidal aromatase inhibitors is permitted)
  • Previous or concurrent malignancy in past 5 years (excluding adequately treated basal cel or spinocellular skin cancer and in situ carcinoma of the cervix)
Show all 14Show fewer
  • Treatment with experimental pharmacologic therapy within 4 weeks of enrollment in the study
  • Unable or unwilling to provide signed informed consent
  • Any concurrent illness that would, in the Investigator's opinion, contraindicate the use of the study drugs.
  • Active infection
  • Assumption of CYP3A4 inhibitors or inducers (ketoconazole, itraconazole, fluconazole, macrolide antibiotics, antidepressives, calcium-antagonists, cimetidine, carbamazepine, phenytoin, barbiturates, rifampicin e glucocorticoids)
  • Pregnancy or lactation
  • Unable to comply with follow-up
  • Active hepatobiliary disease (with the exception of Gilbert's syndrome, asymptomatic biliary calculi, hepatic metastases or stabile chronic hepatopathy)

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

    Naples, 80131

  • Ospedale S. Luca ASL SA 3

    Vallo della Lucania

Other trials in Italy

About this study

Official title: Phase II Multicentered Study of Exemestane and Lapatinib in Advanced Hormone-responsive Breast Cancer

Aromatase inhibitors are the standard treatment for hormone responsive advanced breast cancer. The combination of the aromatase inhibitor exemestane with with another breast cancer drug that blocks epidermal growth factor receptor (EGFR) and Erb-2 activity (lapatinib) is being studied for the possibility of improving response to therapy, and delaying resistance to endocrine therapy.

Read the detailed description

The recommended dose of lapatinib will be determined in the first part of the study. In the second part of the study, patients will receive the recommended dose of lapatinib and exemestane daily, taken orally.

Conditions
Breast Cancer
Being tested
exemestane, lapatinib
Keywords
advanced breast cancer, hormone-responsive, metastatic 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.

  • exemestaneDrug

    25 mg daily

  • lapatinibDrug

    taken orally, daily, at dose recommended after dose finding part of study

Study groups in NCT01005641
Study groupRoleWhat they receive
AExperimentalphase II
Receives: Drug: exemestane; Drug: lapatinib

What is being measured

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

  1. recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer

    Measured: one month after dose selection for each of 3 possible dose levels

  2. proportion of patients free from progression

    Measured: at 6 months

Secondary outcomes (5)

  1. Treatment related toxicity

    Measured: every 4 weeks

  2. objective response

    Measured: at 3 and 6 months

  3. time to progression

    Measured: at 12 months

  4. overall survival

    Measured: 18 months

  5. prognostic role of molecular markers and circulating tumor cells

    Measured: at 18 months

Timeline

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

  1. First posted2 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2011 (estimated)
  4. Study completionMar 2012 (estimated)

Why it stopped: Study not started for administrative reasons

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01005641
Sponsor's protocol ID
ELBA
Other IDs
EudraCT number: 2008-007946-67
Acronym
ELBA
Status last verified
Jul 2012
First submitted
29 Oct 2009
Last updated
13 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exemestane and lapatinib in people with Breast Cancer, run by National Cancer Institute, Naples at 3 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 14 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: withdrawn, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 was withdrawn before enrolling participants, so there are no results.

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?

recommended dose of lapatinib given in combination with standard dose of exemestane in patients with advanced hormone-responsive breast cancer (time frame: one month after dose selection for each of 3 possible dose levels). The study lists 2 primary outcomes in all. 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 NCT01005641.

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 13 Jul 2012.

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