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

3 augustus 2012 bijgewerkt door: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

48

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Georgia
      • Macon, Georgia, Verenigde Staten, 31201
        • Central Georgia Hematology/Oncology Associates, P.C.
    • Kentucky
      • Hopkinsville, Kentucky, Verenigde Staten, 42240
        • Jennie Stuart Medical Center
      • Paducah, Kentucky, Verenigde Staten, 42002
        • Purchase Cancer Group
    • Tennessee
      • Chattanooga, Tennessee, Verenigde Staten, 37404
        • Memorial Health Care System
      • Germantown, Tennessee, Verenigde Staten, 38138
        • The Jones Clinic - Germantown
      • Jackson, Tennessee, Verenigde Staten, 38301
        • Jackson-Madison County Hospital
      • Knoxville, Tennessee, Verenigde Staten, 37909
        • Tennessee Cancer Specialists
      • Nashville, Tennessee, Verenigde Staten, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Verenigde Staten, 37067
        • Vanderbilt-Ingram Cancer Center - Cool Springs

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: First line/hormone-therapy naive
Geneesmiddel: erlotinib hydrochloride
OSI-774 150 mg/day
Andere namen:
  • Tarceva, OSI-774
Geneesmiddel: letrozole
Letrozole 2.5 mg/day
Andere namen:
  • Femara
Genetisch: fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
Andere namen:
  • Niets gespecificeerd
Ander: immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
Andere namen:
  • Niets gespecificeerd
Ander: laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Andere namen:
  • Niets gespecificeerd
Experimenteel: Second-line/prev hormone-therapy tx
Geneesmiddel: erlotinib hydrochloride
OSI-774 150 mg/day
Andere namen:
  • Tarceva, OSI-774
Geneesmiddel: letrozole
Letrozole 2.5 mg/day
Andere namen:
  • Femara
Genetisch: fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
Andere namen:
  • Niets gespecificeerd
Ander: immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
Andere namen:
  • Niets gespecificeerd
Ander: laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Andere namen:
  • Niets gespecificeerd

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Patients With Pathological Complete Response.
Tijdsspanne: at 24 weeks
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
at 24 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Median Time to Progression of Target Lesions
Tijdsspanne: Every 12 weeks from on-study to disease progression
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.
Every 12 weeks from on-study to disease progression
Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)
Tijdsspanne: at 24 weeks
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.
at 24 weeks
Number of Patients With Worst-grade Toxicities Per Grade
Tijdsspanne: at 24 weeks
Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death
at 24 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt-Ingram Cancer Center

Medewerkers

National Cancer Institute (NCI)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2003

Primaire voltooiing (Werkelijk)

1 december 2008

Studie voltooiing (Werkelijk)

1 december 2008

Studieregistratiedata

Eerst ingediend

8 februari 2008

Eerst ingediend dat voldeed aan de QC-criteria

8 februari 2008

Eerst geplaatst (Schatting)

11 februari 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

9 augustus 2012

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2012

Laatst geverifieerd

1 augustus 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VICC BRE 0303
  • VU-VICC-BRE-0303
  • VU-VICC-030592
  • GENENTECH-VU-VICC-BRE-0303
  • NOVARTIS-VU-VICC-BRE-0303

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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