SHORTened Duration of TAMoxifen

Phase 2Active Not RecruitingNCT07806630

Rutgers, The State University of New Jersey250 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

High Risk for Invasive Breast Cancer

Interventions

TamoxifenDRUG

Low-dose tamoxifen will be administered at 10 mg orally every other day for 18 months.

Tamoxifen (Nolvadex)DRUG

Low dose Tamoxifen for 18 months.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

Low Dose Tamoxifen

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.

Time frame: 18 Months

Secondary Outcomes

Evaluation of Tamoxifen Tolerability

Incidence of endometrial cancer or thromembolic events.

Time frame: 18 months

To evaluate the Incidence of other invasive events

Incidence of LCIS or atypical hyperplasia in ipsilateral or contralateral breast.

Time frame: 18 months

Data from ClinicalTrials.gov

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