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Metastatic Breast CancerPhase 2NCT00597597

Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer

A Phase 2 study testing Erlotinib in people with Metastatic Breast Cancer, run by Rush University Medical Center at 1 site 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

The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Apr 2007to Apr 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Verbal and written informed consent to participate in the study.
  • Women greater than or equal to 18 years of age.
  • Histologically documented metastatic or locally advanced, incurable breast cancer with a tumor block available
  • Less than or equal to 1 prior chemotherapy for metastatic or locally unresectable disease.
  • Prior treatment with anthracycline and taxane chemotherapy, either in the adjuvant or metastatic setting
  • Measurable disease on CT or PET scan or physical exam Disease at a previously irradiated site is considered measurable if there is clear evidence of disease progression following radiation therapy.
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  • ER-negative, PR-negative and HER2-neu-negative. Estrogen and progesterone status will be defined by immunohistochemistry. Her2/neu status will be considered negative if the ratio of the number of copies of the Her2/neu gene to the centromeric probe for chromosome 17 is approximately 1. This will be done by FISH (fluorescent in-situ hybridization) testing.
  • EGFR-positive defined as strong membrane staining in greater than 10% of tumor cells by immuno-histochemistry (Dako).
  • Pre- or post-menopausal.
  • ECOG performance status of 0 - 2.
  • Life expectancy of greater than or equal to 3 months.
  • Use of barrier contraceptive methods in women of childbearing potential.
  • Ability to comply with study and follow-up procedures.

Who cannot join

  • Pleural effusions or blastic bone lesions as the only manifestations of the current metastatic breast cancer.
  • Other primary malignancies within 5 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
  • Symptomatic or untreated brain metastases. Subjects are eligible if they are neurologically stable after treatment for brain metastases and have been off steroids for greater than or equal to 4 weeks.
  • Radiotherapy, immunotherapy, hormonal therapy or chemotherapy within 21 days prior to registration.
  • Prior treatment with an agent that targets the EGFR or the EGFR-specific tyrosine kinase activity.
  • Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 0, or serious cardiac arrhythmias requiring medication.
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  • Major surgery, biopsy of a parenchymal organ, or significant traumatic injury occurring within 21 days prior to Day 0.
  • History of other diseases, metabolic dysfunction, physical examinations findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications.
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
  • Pregnancy or lactation. A negative serum or urine pregnancy test is required for women of child-bearing potential during screening and within 7 - 10 days of Day 1 of Cycle 1 of erlotinib (Tarcevo®)administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen while taking erlotinib and for 30 days following the last dose of study drug.
  • Active infection requiring parenteral antibiotics.
  • Any of the following abnormal baseline hematologic values:
  • Granulocyte count less than or equal to 1500/μL
  • Platelet count less than or equal to 100,000/μL
  • Hemoglobin less than or equal to 9g/dl (transfusion permitted)
  • Any of the following abnormal baseline liver function tests:
  • Serum bilirubin greater than or equal to 1.5x upper limit of normal (ULN)
  • Serum ALT and AST greater than or equal to 2.5x ULN (greater than 5x ULN if due to liver metastases)
  • Alkaline phosphatase greater than or equal to 2.5x ULN (greater than 4x ULN if due to liver or bone metastases)
  • Other baseline laboratory values:
  • Serum creatinine greater than or equal to 1.5x ULN or creatinine clearance less than or equal to 60mL/min
  • Uncontrolled hypercalcemia (greater than 11.5mg/dL)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rush University Medical Center Division of Hematology/Oncology

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: A Phase II Open-Label Trial to Evaluate the Efficacy and Toxicity of Tarceva (Erlotinib) in Women With Metastatic, Hormone Receptor Negative and Her2-Negative Breast Cancer

The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer patients. In addition, it may identify a subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR targeted therapies could warrant further testing.

Read the detailed description

This is a Phase II, open-label, single institution trial of treatment with single agent erlotinib. The purpose of the research is to determine the effects erlotinib has on the breast cancer tumors in women with metastatic hormone receptor negative and HER2-negative breast cancer. The Federal Drug Administration (FDA) has approved erlotinib, also known as Tarceva, for the treatment of locally advanced and metastatic non-small cell lung cancer.

To qualify for the trial, subjects must have histologically confirmed, incurable, locally advanced or metastatic breast cancer that is ER-negative, PR-negative, Her2/neu-negative and EGFR-positive. Subjects must have measurable disease. They must have received less than or equal to 1 chemotherapeutic agent in the metastatic setting. The target accrual is 43 subjects. Initially, 18 subjects will be accrued. If at least 3 subjects are progression-free at 4 months, accrual will continue to a maximum of 43 subjects. Subject eligibility will be evaluated during a screening period of 4 weeks. During the treatment period, subjects will receive single agent erlotinib, 150mg/day. Subjects will receive the first dose of erlotinib on Day 0, within 7 days of registration. Efficacy will be assessed by radiographic tumor assessment or photographic documentation. Safety will be assessed by the recording of adverse events and laboratory test results. Subjects with documented progressive disease will be discontinued from treatment and will be followed for survival information every 2 months until death, lost to follow-up or study termination.

Being tested
Erlotinib
Keywords
Metastatic breast cancer, ER and PR hormone receptor negative, HER2/neu negative, EGFR positive
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ErlotinibDrug

    Also called Tarceva

    During the treatment period, subjects will receive single agent erlotinib, 150mg/day.

Study groups in NCT00597597
Study groupRoleWhat they receive
Open label ErlotinibExperimentalOpen label; In this open label study, all enrolled subjects receive active drug, Erlotinib
Receives: Drug: Erlotinib

What is being measured

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

  1. The Primary Objective of the Study is Progression Free Survival.

    From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death.

    Measured: From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months.

Secondary outcomes (5)

  1. Overall Response Rate, Consisting of Complete and Partial Responses According to RECIST Criteria

    Overall response rate, consisting of complete and partial responses according to RECIST criteria "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."

    Measured: every 8 weeks, up to 6 months

  2. Clinical Benefit, Consisting of Complete and Partial Responses, and Stable Disease for Six Months

    We measured the clinical benefit, consisting of complete and partial responses, and stable disease for six months

    Measured: very 8 weeks, up to 6 months

  3. Duration of Objective Response

    Objective response is defined as complete or partial response

    Measured: every 8 weeks, up to 6 months

  4. Safety of Erlotinib

    Number of Participants With Adverse Events

    Measured: 2 years

  5. Number of Participants With Rash

    We evaluated the number of Participants with Rash

    Measured: every 8 weeks, up to 6 months

Timeline

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

  1. First posted18 Jan 2008 (estimated)
  2. Study startApr 2007
  3. Primary completionApr 2011
  4. Study completionApr 2011

Why it stopped: not enough patients enrolled

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597597
Sponsor's protocol ID
OSI-TAR-721 | L06112402
Status last verified
May 2023
First submitted
9 Jan 2008
Last updated
17 May 2023
Data monitoring committee
Yes

Publications

  • J Clin Oncol 29, 2011 (suppl 27; abstr 296)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib in people with Metastatic Breast Cancer, run by Rush University Medical Center 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 13 inclusion and 22 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: stopped early, as of the sponsor's last update on 17 May 2023. 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?

Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Objective of the Study is Progression Free Survival. (time frame: From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months.). 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 NCT00597597, 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 May 2023.

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