Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

SUSPENDED

NCT06671912

PHASE3

Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.

Official title: LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1556

Start Date

2025-02-19

Completion Date

2031-11-30

Last Updated

2026-09-02

Healthy Volunteers

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage 1 Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Estrogen Receptor-Positive Breast Carcinoma HER2-Negative Breast Carcinoma Breast Ductal Carcinoma In Situ Breast Lobular Carcinoma In Situ

Interventions

DRUG

Anastrozole

Given PO

DRUG

Letrozole

Given PO

DRUG

Exemestane

Given PO

DRUG

Tamoxifen

Given PO

PROCEDURE

Mammogram

Undergo mammogram

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Dual X-ray Absorptiometry

Undergo DEXA

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Questionnaire Administration

Ancillary studies

Inclusion Criteria: * Unilateral invasive adenocarcinoma of the breast that is histologically confirmed * Invasive breast cancer is estrogen receptor positive in ≥ 10% of cells * HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * The patient must have a multigene assay with a low-risk score, including any of the following (if more than one genomic assay was obtained, both are required to be low-risk): * Oncotype DX recurrence score ≤ 25 * Mamma Print low risk * Prosigna risk of recurrence ≤ 40 Patients with pathologic tumor size ≤ 0.5cm who meet all other eligibility criteria are eligible for enrollment without multigene assay testing. The total number of enrolled patients with tumor size ≤ 0.5cm without genomic testing will be limited * Tumor size must be ≤ 3 cm by pathologic evaluation. Multifocal tumors are permitted if the largest focus of disease is ≤ 3 cm * Adequate surgical removal of all clinically evident disease in the breast with either breast conserving surgery or mastectomy. Negative margins on final pathology are required. Additional excisions may be performed to obtain clear margins before registration * No clinical (cN1, cN2, cN3) or pathologic (pN1mi, pN1, pN2, or pN3) evidence of lymph node involvement on either needle biopsy or surgical lymph node assessment. Patients with pN0(i+) or pN0 (mol+) are eligible * Surgical axillary staging (sentinel lymph node biopsy ± axillary lymph node dissection) is completed according to physician discretion * For patients age \<70, clinicians may selectively choose to forego surgical axillary staging if an Ipsilateral axillary ultrasound or preop MRI shows no lymph node involvement with no evidence of lymphadenopathy or suspicious thickening is required in this scenario * For patients age ≥ 70 without surgical axillary staging, axillary ultrasound is not required in this scenario but may be obtained at the discretion of the treating investigator * No tumors that are considered pT4 * No definitive clinical or radiologic evidence of metastatic disease * No palpable or radiographically suspicious axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histologic confirmation that these lymph nodes are negative for tumor * No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast, unless biopsied and found to be benign * An interval of no more than 20 weeks between the date of surgery and the date of registration * Must have had a bilateral mammogram or MRI within 9 months prior to registration * Must be intending to take endocrine therapy for 5 years duration * No prior treatment with endocrine therapy or chemotherapy for the currently diagnosed breast cancer prior to registration. (Short course endocrine therapy of ≤ 6 weeks duration is acceptable after core biopsy and before surgery, if genomic testing is assessed on the biopsy core and meets eligibility requirements for a low-risk score.) * No use of oral hormone replacement therapy or transdermal estrogen replacement therapy (patch) within 7 days prior to registration * Age ≥ 18 years and female * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Postmenopausal status confirmed as one of the following: * No spontaneous menses ≥ 1 year or * No menses for \< 1 year with follicle stimulating hormone (FSH) and estradiol levels within a postmenopausal range according to institutional standards or * Previous bilateral surgical oophorectomy * None of the following conditions: * Abnormal or dysfunctional uterine bleeding within 1 year prior to study enrollment or * Any patient with known atypia or endometrial pathology that the opinion of the treating investigator would place the patient at undue risk of endometrial cancer with tamoxifen or * Any patient with a known hypercoagulable state that in the opinion of the treating investigator would put the patient at undue risk of venous thromboembolism with tamoxifen * No history of breast or thoracic radiotherapy for any previous condition. Patients may complete radiotherapy for the currently diagnosed breast cancer prior to registering for the study. In this scenario, registration must be completed within 12 weeks of completing breast radiotherapy * No previous history of ipsilateral invasive breast cancer or ipsilateral ductal carcinoma in situ (DCIS), regardless of the disease-free interval * No synchronous or previous history of contralateral invasive breast cancer or DCIS * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * No current treatment with any endocrine therapy for breast cancer prevention or osteoporosis, including raloxifene, tamoxifen, or other selective estrogen receptor modulator. Patients intending to continue oral hormone replacement are not eligible * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Locations (732)

Katmai Oncology Group

Anchorage, Alaska, United States

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Arizona Center for Cancer Care - Biltmore

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Osborn

Scottsdale, Arizona, United States

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

Arizona Center for Cancer Care

Tempe, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

UCSF Cancer Center - Berkeley

Berkeley, California, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Keck Medicine of USC Buena Park

Buena Park, California, United States

UCSF Cancer Center Burlingame

Burlingame, California, United States

Marshall Cancer Center

Cameron Park, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Enloe Medical Center

Chico, California, United States

City of Hope Corona

Corona, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Stanford Cancer Center Emeryville

Emeryville, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Washington Health

Fremont, California, United States

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

City of Hope Seacliff

Huntington Beach, California, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

City of Hope at Long Beach Elm

Long Beach, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Kaiser Permanente- Modesto MOB II

Modesto, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

City of Hope Newport Beach

Newport Beach, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Wilma Chan Highland Hospital

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Stanford Cancer Center South Bay

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

UCSF Cancer Center - San Mateo

San Mateo, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Cedars-Sinai Cancer - Tarzana

Tarzana, California, United States

City of Hope South Bay

Torrance, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

City of Hope Upland

Upland, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

UCI Health - Yorba Linda

Yorba Linda, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Intermountain Health Platte Valley Hospital

Brighton, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

UCHealth - Cherry Creek

Denver, Colorado, United States

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, United States

Shaw Cancer Center

Edwards, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Good Samaritan Hospital - Cancer Centers of Colorado

Lafayette, Colorado, United States

UCHealth Lone Tree Health Center

Lone Tree, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Saint Anthony North Hospital

Westminster, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

And 632 more locations on ClinicalTrials.gov

Clinical Research Directory

Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (732)