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Breast CancerPhase 2NCT00632723

IRESSA™ (Gefitinib) in Breast Cancer Patients

A Phase 2 study testing gefitinib (IRESSA™, ZD1839) in people with Breast Cancer, run by AstraZeneca.

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

This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in patients with breast cancer. The trial proposes to enter 27 patients who have acquired resistance to tamoxifen and 27 patients with ER negative tumours. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
gefitinib (IRESSA™, ZD1839)
Type of treatment
Pill or oral medicine
How many people
54 participants
Where
No sites listed yet
Study dates
Apr 2001to Oct 2005
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histological or cytological confirmation of breast cancer that is either
  • a primary tumour in a patient unfit for or who has declined surgery
  • advanced (locally or metastatic) disease
  • acquired resistance to tamoxifen or ER negative tumour
  • at least one measurable or assessable lesion
  • WHO performance status 0 - 2
  • life expectancy of 12 weeks or more

Who cannot join

  • more than one previous chemotherapy regimens for advanced disease
  • prior anthracycline chemotherapy (> 250 mg/m2 adriamycin)
  • radiotherapy completed within 14 days prior to Day 1 of treatment
  • incomplete healing from prior oncologic or other major surgery
  • signs of neurological symptoms consistent with spinal cord compression
  • any evidence of clinically active interstitial lung disease (patients with chronic stable

About this study

Official title: A Phase II Trial to Assess the Efficacy of IRESSA™ (Gefitinib) 500 mg/Day in Patients With Breast Cancer Who Have Failed Tamoxifen or Have an Oestrogen Receptor Negative Tumour and Would be Considered for Systemic Therapy

This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in patients with breast cancer. The trial proposes to enter 27 patients who have acquired resistance to tamoxifen and 27 patients with ER negative tumours. However for each of these two types of patients recruitment will stop after 14 patients have been entered in order to confirm that IRESSA™ (gefitinib)has anti-tumour efficacy. If no patient out of 14 in a group has shown clinical benefit (ie an objective response (CR or PR) or stable disease (SD) for at least 24 weeks) then a clinical benefit rate of >20% can be ruled out with >95% certainty. If one or more of the objective response or stable disease (> 24 weeks) has been seen in the first 14 patients recruited in a group then recruitment to that group will recommence to a total of 27 patients. If 14 patients are entered into an arm but not all 14 patients are available for final analysis and the toxicity/safety and tolerability profile of the therapy is acceptable and documented and a clinical benefit is seen in the patients, enrolment of additional patients beyond the initial 14 may be made based on overall clinical assessment.

Conditions
Breast Cancer
Being tested
gefitinib (IRESSA™, ZD1839)
Keywords
oestrogen receptor, ER negative tumours, epidermal growth factor receptor (EGFR)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • gefitinib (IRESSA™, ZD1839)Drug

    Also called IRESSA™, ZD1839

    250 mg tablet; daily dose 500 mg daily

What is being measured

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

  1. Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria

    Measured: Assessed after 24 weeks

  2. Clinical benefit (CR + PR + SD > 24 wks)

    Measured: After 24 weeks of treatment

  3. Frequency and severity of adverse events (AEs)

    Measured: Assessed at each visit

Secondary outcomes (2)

  1. Progression-free survival

    Measured: Time to death

  2. Duration of response

    Measured: Time to progression

Timeline

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

  1. First posted11 Mar 2008 (estimated)
  2. Study startApr 2001
  3. Study completionOct 2005

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00632723
Sponsor's protocol ID
1839IL/0057
Status last verified
Apr 2009
First submitted
17 Jan 2008
Last updated
22 Apr 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gefitinib (IRESSA™, ZD1839) in people with Breast Cancer, run by AstraZeneca.

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 7 inclusion and 6 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 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

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?

Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria (time frame: Assessed after 24 weeks). The study lists 3 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 NCT00632723.

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 22 Apr 2009.

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