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Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

19. maj 2014 opdateret af: Lynn Henry, University of Michigan Rogel Cancer Center

Women with hormone-receptor positive breast cancer are typically treated with hormone therapy as part of their treatment after surgery. In the past few years it has been found that treatment with aromatase inhibitors is superior to tamoxifen in postmenopausal women. Tamoxifen is still used for premenopausal women, however, because aromatase inhibitors are not effective in women who have functioning ovaries. Some women are premenopausal at the time they are diagnosed with breast cancer, but then stop having menstrual periods when they are treated with chemotherapy. It is unclear if these women can also be treated safely with aromatase inhibitors.

In this clinical trial the researchers will try to answer this question. Women with hormone receptor positive breast cancer who become postmenopausal with chemotherapy will be invited to participate in this study. Each woman will be treated with one of the aromatase inhibitors, anastrozole (Arimidex), and then carefully monitored to ensure that her ovaries do not start making estrogen. If her estrogen level remains low, then she will continued to be followed for 18 months. If the level increases to the level typically seen in premenopausal women, however, then she will stop taking part in this study.

The study will also evaluate multiple factors that may help doctors predict who will tolerate the therapy without having their ovaries start making estrogen again. Some of the factors to be evaluated include other hormone levels (blood tests) as well as family history of early menopause (mother, sisters). In addition, changes in certain genes that affect how patients' bodies handle chemotherapy drugs will be tested to see if they affect whether or not patients recover ovarian function. Overall, the purpose of the study is to determine which patients who become postmenopausal from chemotherapy are likely to tolerate aromatase inhibitor treatment safely, and how often the patients' ovarian function needs to be tested during treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

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
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231-2410
        • Sidney Kimmel Comprehensive Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan

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 til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

To be eligible for this study:

  1. You must be at least 18 years of age and not older than 60 years of age
  2. You have breast cancer which was confined to the breast and lymph nodes under the arm, and have no evidence of cancer elsewhere
  3. You must have had surgical removal of your tumor, and if indicated, radiation therapy must have been completed or planned
  4. Your tumor must express estrogen and/or progesterone receptors
  5. You must have had a menstrual period within 6 months before starting chemotherapy for your breast cancer.
  6. You must have been treated with a chemotherapy regimen that includes cyclophosphamide (Cytoxan). Your menstrual periods must have stopped for at least 8 weeks starting during or after chemotherapy.

Exclusion Criteria:

You are not eligible to participate in this study if:

1. Your ovaries have been surgically removed, treated with radiation therapy, or if you are taking medications (Zoladex™ or Lupron™) to block the function of your ovaries.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: anastrozole
Medicin: anastrozole
1 mg tablet by mouth once a day
Andre navne:
  • Arimidex

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy
Tidsramme: 12 months
In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan Rogel Cancer Center

Efterforskere

  • Ledende efterforsker: Norah L. Henry, M.D., Ph.D., University of Michigan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. august 2007

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

6. november 2007

Først indsendt, der opfyldte QC-kriterier

7. november 2007

Først opslået (Skøn)

8. november 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UMCC 2007.044
  • HUM 12443 (Anden identifikator: University of Michigan Medical IRB)

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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