AzTrials
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Breast CancerPhase 2NCT00082667

Gefitinib Followed By Surgery in Treating Women With Ductal Carcinoma In Situ of the Breast

A Phase 2 study testing gefitinib and Surgery in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.

Terminated

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

Official record
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Trial summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ. Read more about this study

Who is it for?
Ages 35 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
gefitinib and Surgery
Type of treatment
Surgery or procedure
How many people
1 participants
Where
2 sitesUnited States
Study dates
Oct 2002to Jun 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 35 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS
  • No invasive disease
  • Not completely excised
  • Epidermal growth factor receptor (EGFR) positive (> 10% of cells stained)
  • Planned lumpectomy or mastectomy within the next 2-4 weeks
  • Hormone receptor status:
  • Estrogen receptor status known

PATIENT CHARACTERISTICS:

Age

  • 35 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 mg/dL
  • SGOT ≤ 2 times upper limit of normal (ULN)
  • SGPT < 1.5 times ULN
  • PT and PTT ≤ 1.5 times ULN
  • INR ≤ 1.5 times ULN

Renal

  • Creatinine < 1.5 mg/dL

Cardiovascular

  • No New York Heart Association class I-IV heart disease

Pulmonary

  • No acute asthma

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Random blood sugar < 2.5 times ULN
  • No known hypersensitivity to study drug or its excipients
  • No nonhealing wound or fracture
  • No active infection
  • No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix
  • No psychosis or severe depression
  • No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior trastuzumab (Herceptin®)

Chemotherapy

  • At least 1 year since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • At least 1 year since prior aromatase inhibitors
  • At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists
  • No concurrent glucocorticoids
  • Concurrent oral contraceptives allowed
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • At least 1 year since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior oncologic or other major surgery
  • No prior organ allograft

Other

  • Recovered from all prior therapy (except alopecia)
  • More than 30 days since prior non-approved or investigational drugs
  • No prior definitive local therapy
  • No prior immunosuppressive therapy
  • No prior gefitinib
  • No other prior EGFR inhibitors
  • No other concurrent cytotoxic drugs
  • No concurrent warfarin for anticoagulation
  • No concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Barbiturates
  • Rifampin
  • Phenobarbital
  • Hypericum perforatum (St. John's wort)
  • Ethosuximide
  • Griseofulvin
  • Nafcillin
  • Nelfinavir
  • Nevirapine
  • Oxcarbazepine
  • Phenylbutazone
  • Primidone
  • Rifabutin
  • Rofecoxib
  • Sulfamethazine
  • Sulfinpyrazone
  • Troglitazone
  • No concurrent antiretroviral treatment for HIV-positive patients

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

Official title: EGFR Pathway Modulation In Patients With Ductal Carcinoma In Situ Of The Breast

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether surgery is more effective with or without gefitinib in treating ductal carcinoma in situ.

PURPOSE: This randomized phase II trial is studying how well gefitinib together with surgery works compared to surgery alone for the treatment of women with ductal carcinoma in situ of the breast.

Read the detailed description

OBJECTIVES:

Primary

  • Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by local surgery.
  • Compare the effect of these regimens on cell turnover in vivo in EGFR-positive vs EGFR-negative patients.

Secondary

  • Compare the efficacy of these regimens in estrogen-receptor (ER)-positive vs ER-negative and in HER2-positive vs HER2-negative patients with DCIS.
  • Correlate levels of HER2 extracellular domain with biomarker modulation in patients treated with these regimens.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral gefitinib once daily for 7-14 days or until the day before local surgery. Patients then undergo lumpectomy or mastectomy.
  • Arm II: Patients receive oral placebo once daily for 7-14 days or until the day before local surgery. Patients then undergo local surgery as in arm I.

PROJECTED ACCRUAL: A total of 78 patients (39 per treatment arm) will be accrued for this study within 1.5 years.

Conditions
Breast Cancer
Being tested
gefitinib, Surgery
Keywords
breast cancer in situ, ductal breast carcinoma in situ
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating

What participants receive

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

  • gefitinibDrug

    Also called ZD 1839, Iressa

  • SurgeryProcedure or surgery

    Also called lumpectomy or mastectomy of the breast

What is being measured

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

  1. Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery.

    Measured: at time of surgery, after 7-14 days of gefitinib

Secondary outcomes (2)

  1. Compare the effect of gefitinib vs. placebo, followed by surgery on cell turnover in vivo in EGFR-positive vs. EGFR-negative patients

    Measured: at time of surgery, after 7-14 days of gefitinib

  2. Compare the effects of gefitinib in ER-positive vs. ER-negative DCIS and in HER2-positive vs. HER2-negative DCIS

    Measured: at time of surgery, after 7-14 days of gefitinib

Timeline

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

  1. First posted19 May 2004 (estimated)
  2. Study startOct 2002
  3. Primary completionJul 2004
  4. Study completionJun 2005

Why it stopped: PI left VICC

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082667
Sponsor's protocol ID
VICC BRE 0249
Other IDs
P30CA068485, VICC-BRE-0249
Status last verified
Feb 2013
First submitted
14 May 2004
Last updated
25 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gefitinib and Surgery in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites 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?

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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: PI left VICC). 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?

Compare epidermal growth factor receptor (EGFR) pathway biomarker modulation in tissue samples of women with ductal carcinoma in situ (DCIS) of the breast treated with gefitinib vs placebo followed by surgery. (time frame: at time of surgery, after 7-14 days of gefitinib). 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 NCT00082667.

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 25 Feb 2013.

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