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Breast CancerPhase 2NCT00611715

Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

A Phase 2 study testing erlotinib hydrochloride, letrozole and fluorescence in situ hybridization in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 9 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: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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?
erlotinib hydrochloride, letrozole and fluorescence in situ hybridization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
9 sitesUnited States
Study dates
Nov 2003to Dec 2008
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
  • Patients must have estrogen (ER) and/or progesterone receptor (PgR)-positive, histologically confirmed adenocarcinoma of the breast with measurable (but not operable) locally recurrent disease, or measurable and/or evaluable metastatic disease (see protocol section 10.3), including isolated bone metastases.
  • Patients with available paraffin tissue blocks from either the primary or the metastatic site must submit tissue blocks for retrospective EGFR and HER2 analysis. If tissue blocks cannot be submitted, 20 unstained slides from each paraffin block must be submitted.
  • All patients must be post-menopausal females as defined by one of the following:
  • Prior bilateral oophorectomy
  • Prior bilateral ovarian irradiation
  • No menstrual period for 12 months or longer
  • If age 55 years or less and < 12 months from last menstrual period, patient must have a serum estradiol < or equal to 30 and an FSH level > 40.
  • Patients must not have had more than 1 prior chemotherapy regimen for metastatic disease and have fully recovered from any grade 2-4 toxicities related to chemotherapy. No concurrent chemotherapy is allowed while on protocol therapy.
  • Patients may have had 1 prior hormonal therapy for metastatic disease. This includes: tamoxifen, fulvestrant, anastrozole, exemestane, aminoglutethimide, megace, and letrozole. Patients may have received tamoxifen or aromatase inhibitors in the adjuvant setting.
  • Patients must not have had prior therapy with EGF receptor inhibitors.
  • Previous but not concomitant therapy with trastuzumab (Herceptin) is allowed. Patients must not have received Herceptin within 4 weeks of initiation of protocol therapy.
  • Patients must have an ECOG performance status of 0, 1, or 2.
  • Patients must have adequate hematologic, hepatic, and renal function as defined by the following within 2 weeks of initiation of therapy:
  • Absolute neutrophils > or equal to 1,500/mm3 and platelets > or equal to 100,000/mm3.
  • Bilirubin < than or equal to 1.5 upper limit of normal.
  • SGOT and SGPT < or equal to 2.5 upper limit of normal.
  • Creatinine < or equal to 1.5 upper limit of normal.
  • INR, PTT and PT in the normal range.
  • Must be 18 years of age or older.
  • Patients must not have a history of central nervous system metastases or unevaluated CNS symptoms suggestive of possible brain metastases.
  • Patients may receive concurrent radiation therapy to painful bone metastases or areas of impending bone fracture as long as radiation therapy is initiated prior to study entry and sites of evaluable disease outside the radiation port(s) are available for follow-up. Patients who have received prior radiotherapy must have recovered from toxicity induced by this treatment.
  • Patients < 55 years of age must not have received Luteinizing hormone releasing hormone (LHRH) antagonists within 3 months prior to protocol therapy.
  • Patients must not suffer from medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements including maintenance of a compliance/pill diary.
  • Patients must be disease-free of prior invasive cancers for > 5 years with the exception of basal or squamous cancer of the skin or cervical carcinoma in situ.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Memorial Health Care System

    Chattanooga, Tennessee, 37404

  • The Jones Clinic - Germantown

    Germantown, Tennessee, 38138

  • Jennie Stuart Medical Center

    Hopkinsville, Kentucky, 42240

  • Jackson-Madison County Hospital

    Jackson, Tennessee, 38301

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Central Georgia Hematology/Oncology Associates, P.C.

    Macon, Georgia, 31201

  • Vanderbilt-Ingram Cancer Center - Cool Springs

    Nashville, Tennessee, 37067

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Purchase Cancer Group

    Paducah, Kentucky, 42002

Other trials in United States

About this study

Official title: A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the rate of clinical benefit (complete response [CR], partial response [PR], and stable disease [SD] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride.

Secondary

  • To determine the time to progression (TTP) in patients treated with this regimen.
  • To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen in these patients.
  • To evaluate the safety of this regimen in these patients.
  • To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP from the combination compared to tumors that do not express or overexpress these molecules.

OUTLINE: This is a multicenter study. Patients are stratified according to prior hormone therapy (hormone-therapy naive/first-line therapy vs prior hormonal therapy with either tamoxifen or an aromatase inhibitor in the adjuvant or metastatic setting/second-line therapy)

Patients receive oral letrozole and oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.

Conditions
Breast Cancer
Being tested
erlotinib hydrochloride, letrozole, fluorescence in situ hybridization, immunohistochemistry staining method, laboratory biomarker analysis
Keywords
recurrent breast cancer, stage IV 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.

  • erlotinib hydrochlorideDrug

    Also called Tarceva, OSI-774

    OSI-774 150 mg/day

  • letrozoleDrug

    Also called Femara

    Letrozole 2.5 mg/day

  • fluorescence in situ hybridizationGenetic

    Also called None specified

    To determine HER2 gene amplification or excess copies of the HER2 gene

  • immunohistochemistry staining methodOther

    Also called None specified

    to measure the epidermal growth factor receptors (EGFR)

  • laboratory biomarker analysisOther

    Also called none specified

    To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

Study groups in NCT00611715
Study groupRoleWhat they receive
First line/hormone-therapy naiveExperimentalNot described
Receives: Drug: erlotinib hydrochloride; Drug: letrozole; Genetic: fluorescence in situ hybridization; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis
Second-line/prev hormone-therapy txExperimentalNot described
Receives: Drug: erlotinib hydrochloride; Drug: letrozole; Genetic: fluorescence in situ hybridization; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis

What is being measured

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

  1. Number of Patients With Pathological Complete Response.

    Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions

    Measured: at 24 weeks

Secondary outcomes (3)

  1. Median Time to Progression of Target Lesions

    Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.

    Measured: Every 12 weeks from on-study to disease progression

  2. Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)

    Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions.

    Measured: at 24 weeks

  3. Number of Patients With Worst-grade Toxicities Per Grade

    Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death

    Measured: at 24 weeks

Timeline

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

  1. First posted11 Feb 2008 (estimated)
  2. Study startNov 2003
  3. Primary completionDec 2008
  4. Study completionDec 2008

Why it stopped: low accrual

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
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00611715
Sponsor's protocol ID
VICC BRE 0303
Other IDs
VU-VICC-BRE-0303, VU-VICC-030592, GENENTECH-VU-VICC-BRE-0303, NOVARTIS-VU-VICC-BRE-0303
Status last verified
Aug 2012
First submitted
8 Feb 2008
Last updated
9 Aug 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, letrozole and fluorescence in situ hybridization in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 9 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Yes. Results are posted in the registry (first posted 13 Jul 2012). 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?

Number of Patients With Pathological Complete Response. (time frame: at 24 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 NCT00611715.

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 9 Aug 2012.

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