SHORTened Duration of TAMoxifen
SHORTened Duration of TAMoxifen for Risk Reduction in Breast Intraepithelial Neoplasms in Post-menopausal Women
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The patients to be entered in this protocol will be post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical ductal hyperplasia, and atypical lobular hyperplasia (ALH) OR post-menopausal women with an elevated 5-year Gail model risk (> 1.66%) but with no prior history of breast intraepithelial or invasive cancers
Potential subjects will be recruited by the treating investigator and approached to participate in the study during consultation for the treatment and management of their disease as an alternative treatment option.
Subjects from all racial/ethnic groups are eligible for this study if they meet the eligibility criteria
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Rutgers Cancer Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 1. Patient at high risk for invasive breast cancer (either A or B)
A. Post-menopausal women diagnosed with ductal carcinoma in situ (DCIS), Lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), and atypical lobular hyperplasia (ALH) who meet the following criteria:
DCIS/LCIS
- Lesion size ≤3cm
- Low or intermediate grade
- Lesion completely excised by surgical excision
- Margins >2cm for DCIS
- Estrogen receptor (ER) positive and/or Progesterone receptor positive (defined as ≥10%)
- ADH/ALH o Lesion completely excised by surgical excision
B. Patients at increased risk of breast cancer based on Gail model criteria (5- year risk ≥1.66%) without prior history of DCIS, LCIS, atypical hyperplasia, or invasive breast cancer.
2. No history of pathogenic germline mutations that increase the lifetime risk of breast cancer. If genetic testing was not done, then patients must have no more than two first-degree relatives diagnosed with breast cancer.
3. Should have received adjuvant radiation for DCIS, if recommended by the radiation oncologist.
4. No prior history of invasive carcinoma, DCIS, LCIS, ADH, and/or ALH in bilateral breasts.
5. ECOG performance status ≤ 2 6. No use of hormone replacement therapy for at least 5 years.
Exclusion Criteria:
- Evidence of invasive or microinvasive breast cancer.
- Current use of dicumarols and CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors.
- Patients who have had a bilateral mastectomy for risk reduction.
- Prior history of any malignancy in the last 5 years (except squamous cell carcinoma/basal cell carcinoma of skin)
- Patients who are known to be pregnant
- Patients who cannot voluntarily provide informed consent. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.
- Life expectancy of less than 1 year per treating physician.
Prior treatment with tamoxifen or an aromatase inhibitor.
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Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Low dose Tamoxifen
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Low-dose tamoxifen will be administered at 10 mg orally every other day for 18 months.
Low dose Tamoxifen for 18 months.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Low Dose Tamoxifen
Tidsramme: 18 Months
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To evaluate the efficacy of a de-escalated, 18-month regimen of low-dose tamoxifen (10 mg every other day) in reducing the risk of disease recurrence or invasive breast cancer in post-menopausal women with breast intraepithelial neoplasia or an elevated 5-year Gail model risk.
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18 Months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluation of Tamoxifen Tolerability
Tidsramme: 18 months
|
Incidence of endometrial cancer or thromembolic events.
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18 months
|
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To evaluate the Incidence of other invasive events
Tidsramme: 18 months
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Incidence of LCIS or atypical hyperplasia in ipsilateral or contralateral breast.
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18 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mridula George, MD, Rutgers Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 042606
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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