SHORTened Duration of TAMoxifen

NCT07806630 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 042606
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk for Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  18 Months

Secondary Outcomes (2)

• Evaluation of Tamoxifen Tolerability

  18 months

• To evaluate the Incidence of other invasive events

  18 months

Study Arms (1)

Low dose Tamoxifen

EXPERIMENTAL

Drug: Tamoxifen; Drug: Tamoxifen (Nolvadex)

Interventions

Tamoxifen DRUG

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

Low dose Tamoxifen

Tamoxifen (Nolvadex) DRUG

Low dose Tamoxifen for 18 months.

Low dose Tamoxifen

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. Should have received adjuvant radiation for DCIS, if recommended by the radiation oncologist.
• \. No prior history of invasive carcinoma, DCIS, LCIS, ADH, and/or ALH in bilateral breasts.
• \. ECOG performance status ≤ 2 6. No use of hormone replacement therapy for at least 5 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Interventions

Tamoxifen

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mridula George, MD

  Rutgers Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Program Director, Breast Medical Oncology

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)