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

3. august 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: First line/hormone-therapy naive
Medicin: erlotinib hydrochloride
OSI-774 150 mg/day
Andre navne:
  • Tarceva, OSI-774
Medicin: letrozole
Letrozole 2.5 mg/day
Andre navne:
  • Femara
Genetisk: fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
Andre navne:
  • Ingen angivet
Andet: immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
Andre navne:
  • Ingen angivet
Andet: laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Andre navne:
  • ingen specificeret
Eksperimentel: Second-line/prev hormone-therapy tx
Medicin: erlotinib hydrochloride
OSI-774 150 mg/day
Andre navne:
  • Tarceva, OSI-774
Medicin: letrozole
Letrozole 2.5 mg/day
Andre navne:
  • Femara
Genetisk: fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
Andre navne:
  • Ingen angivet
Andet: immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
Andre navne:
  • Ingen angivet
Andet: laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Andre navne:
  • ingen specificeret

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients With Pathological Complete Response.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Median Time to Progression of Target Lesions
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt-Ingram Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2003

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

8. februar 2008

Først indsendt, der opfyldte QC-kriterier

8. februar 2008

Først opslået (Skøn)

11. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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