SHORTened Duration of TAMoxifen
SHORTened Duration of TAMoxifen for Risk Reduction in Breast Intraepithelial Neoplasms in Post-menopausal Women
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- Rutgers Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Low Dose Tamoxifen
Tidsram: 18 Months
|
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.
|
18 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of Tamoxifen Tolerability
Tidsram: 18 months
|
Incidence of endometrial cancer or thromembolic events.
|
18 months
|
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To evaluate the Incidence of other invasive events
Tidsram: 18 months
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Incidence of LCIS or atypical hyperplasia in ipsilateral or contralateral breast.
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18 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Mridula George, MD, Rutgers Cancer Institute
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 042606
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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