High Risk for Invasive Breast Cancer
Conditions
Brief summary
The purpose of this study is to learn whether a shorter-duration, low-dose tamoxifen regimen can reduce the risk of developing breast cancer or breast cancer recurrence in post-menopausal women who are at increased risk for breast cancer.
Detailed description
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
Interventions
DRUGTamoxifen
Low-dose tamoxifen will be administered at 10 mg orally every other day for 18 months.
Low dose Tamoxifen for 18 months.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The primary objective of this trial is to evaluate the efficacy of a shortened, low-dose chemoprevention regimen (tamoxifen 10 mg every other day for 18 months) in reducing the risk of developing invasive breast cancer or ipsilateral/contralateral breast recurrence in patients diagnosed with breast intraepithelial neoplasia (DCIS, ADH, ALH, LCIS) or those with an elevated 5-year Gail model risk (\> 1.66%). This objective aims to determine whether further shortening the duration of low-dose therapy can maintain the meaningful risk reduction observed in prior trials (such as TAM-01) while minimizing treatment burden and toxicities.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
1. Evidence of invasive or microinvasive breast cancer. 2. Current use of dicumarols and CYP2D6 inhibitors, such as selective serotonin reuptake inhibitors. 3. Patients who have had a bilateral mastectomy for risk reduction. 4. Prior history of any malignancy in the last 5 years (except squamous cell carcinoma/basal cell carcinoma of skin) 5. Patients who are known to be pregnant 6. 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. 7. Life expectancy of less than 1 year per treating physician. 8. Prior treatment with tamoxifen or an aromatase inhibitor. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Dose Tamoxifen | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Tamoxifen Tolerability | 18 months | Incidence of endometrial cancer or thromembolic events. |
| To evaluate the Incidence of other invasive events | 18 months | Incidence of LCIS or atypical hyperplasia in ipsilateral or contralateral breast. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMridula George, MD
Rutgers Cancer Institute
Outcome results
None listed