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AzTrials

Male Breast CancerPhase 2NCT00024154

Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer

A Phase 2 study testing trastuzumab, gefitinib and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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 phase II trial is studying how well giving trastuzumab together with gefitinib works in treating patients with HER2-positive breast cancer. The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
trastuzumab, gefitinib and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteUnited States
Study dates
Feb 2002to Jul 2007
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

  • Histologically confirmed metastatic adenocarcinoma of the breast
  • Patients may have had or not had standard first-line chemotherapy for the treatment of metastatic disease
  • Overexpression of HER2-neu (HER2 3+ by immunohistochemistry or gene amplification as measured by fluorescent in situ hybridization)
  • Measurable disease
  • Patients with no prior adjuvant chemotherapy may have failed or not failed first-line chemotherapy for metastatic disease
  • No more than 2 prior systemic chemotherapy regimens for metastatic disease
Show all 52Show fewer
  • Relapse while receiving or within 6 months of completion of adjuvant chemotherapy is considered failure of 1 regimen for metastatic disease
  • No untreated brain metastases or brain metastases undergoing radiotherapy
  • Previously treated brain metastasis that has responded to radiotherapy and/or surgery allowed if not sole site of measurable disease
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-2
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases is present)
  • INR no greater than 1.5 times ULN
  • PT and PTT no greater than 1.5 times ULN
  • Creatinine no greater than 1.5 mg/dL
  • No more than trace blood or protein in urine
  • LVEF ≥ 50% by MUGA scan
  • No prior New York Heart Association class I-IV heart disease
  • No PR prolongation or atrioventricular block on ECG
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception (preferably nonhormonal)
  • Random blood sugar less than 2.5 times ULN
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
  • No prior trastuzumab (Herceptin)
  • No other concurrent immunologic therapy
  • See Disease Characteristics
  • Recovered from prior cytotoxic chemotherapy
  • No prior cumulative dose of doxorubicin more than 360 mg/m^2
  • No concurrent chemotherapy
  • At least 2 weeks since prior hormonal therapy
  • No concurrent hormonal therapy, including tamoxifen
  • No concurrent dexamethasone, progesterone, or glucocorticoids
  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy
  • No prior radiotherapy to target lesions or only site of measurable disease
  • No concurrent radiotherapy
  • See Disease Characteristics
  • No prior organ allograft
  • No prior gefitinib
  • No prior immunosuppressive therapy
  • At least 2 weeks since prior cytotoxic drugs
  • No concurrent carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, Hypericum perforatum (St. John's Wort), sulfadimidine, sulfinpyrazone, troglitazone, or grapefruit juice
  • No other concurrent investigational agents
  • No concurrent topical eye agents
  • Concurrent bisphosphonates allowed for hypercalcemia and/or prophylaxis of bone metastases

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase I/II Trial of Herceptin and ZD1839 (Iressa, NSC #715055, IND#61187) in Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu (erbB-2)

This phase II trial is studying how well giving trastuzumab together with gefitinib works in treating patients with HER2-positive breast cancer. The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as gefitinib may also interfere with the growth of tumor cells and may enhance the effects of trastuzumab. Combining trastuzumab with gefitinib may be an effective treatment for metastatic breast cancers with high amounts of HER2

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the response rate, duration of response, and time to progression in patients with metastatic breast cancer that overexpresses HER2-neu treated with trastuzumab (Herceptin) and gefitinib.

II. Determine the phase II dose of gefitinib when given in combination with trastuzumab in these patients.

III. Determine the toxicity of this regimen in these patients. IV. Determine the 3- and 6-month progression-free survival of patients treated with this regimen.

  1. Correlate response rates with plasma levels of circulating HER2 and tumor levels of epidermal growth factor receptor, activated HER2, and HER2 receptors, as measured by immunohistochemistry and/or fluorescent in situ hybridization (FISH), in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of gefitinib. The phase I portion of this study was open in only 5 ECOG institutions. The phase I portion has been completed, and the study is being opened in all ECOG-affiliated institutions.

Phase I (completed): Patients receive trastuzumab (Herceptin) IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1.

Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to the phase II portion of the study and are treated at that dose.

Phase II: Patients receive oral gefitinib once daily (at the MTD established in phase I) and trastuzumab IV weekly until week 24, at which time trastuzumab is given every 3 weeks (with daily gefitinib) until disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until 2 years from study entry.

Being tested
trastuzumab, gefitinib, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

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

  • trastuzumabBiological

    Also called anti-c-erB-2, Herceptin, MOAB HER2

    Given IV

  • gefitinibDrug

    Also called Iressa, ZD 1839

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00024154
Study groupRoleWhat they receive
Treatment (trastuzumab, gefitinib)ExperimentalPhase I (completed): Patients receive trastuzumab (Herceptin) IV over 30-90 minutes once weekly and oral gefitinib once daily beginning on day 1. Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is established, additional patients are accrued to the phase II portion of the study and are treated at that dose. Phase II: Patients receive oral gefitinib once daily (at the MTD established in phase I) and trastuzumab IV weekly until week 24, at which time trastuzumab is given every 3 weeks (with daily gefitinib) until disease progression or unacceptable toxicity.
Receives: Biological: trastuzumab; Drug: gefitinib; Other: laboratory biomarker analysis

What is being measured

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

  1. MTD and DLT in patients treated with Herceptin and ZD1839 graded using the NCI CTC (Phase I)

    Measured: 4 weeks

Secondary outcomes (2)

  1. Median time to progression (Phase II)

    Measured: 6 months

  2. Progression-free survival (Phase II)

    Measured: 3 months

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2002
  3. Primary completionJul 2007

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
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024154
Sponsor's protocol ID
NCI-2012-02411
Other IDs
E1100, U10CA021115, CDR0000068896
Status last verified
Jan 2013
First submitted
13 Sep 2001
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab, gefitinib and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) 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 52 inclusion and 0 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 24 Jan 2013. 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?

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?

MTD and DLT in patients treated with Herceptin and ZD1839 graded using the NCI CTC (Phase I) (time frame: 4 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 NCT00024154.

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 24 Jan 2013.

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