Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Nov 1, 2024
Trial Information
Current as of November 01, 2025
Recruiting
Keywords
ClinConnect Summary
The LoTam Trial is a study looking at how effective a low dose of tamoxifen is for treating early-stage breast cancer in post-menopausal women. Tamoxifen is a medication that blocks estrogen, a hormone that some breast cancers need to grow. The trial compares this low dose of tamoxifen to standard hormone treatments, which include other medications that stop the body from making estrogen. Researchers hope that low dose tamoxifen may work better for certain types of hormone-positive, HER2-negative breast cancers.
To join the trial, participants must be post-menopausal women aged 18 or older with a specific type of breast cancer that is confirmed to be estrogen receptor positive and HER2 negative. They should have had surgery to remove their breast cancer and meet several other health criteria. If eligible, participants can expect to take the study medication for at least five years, with regular check-ins to monitor their health. This trial is currently recruiting, and it's an important opportunity for women looking for effective treatments for their breast cancer.
Gender
ALL
Eligibility criteria
- 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
- • Tumor size must be ≤ 3 cm by pathologic evaluation
- • 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 with negative preoperative axillary ultrasonography, clinicians may selectively choose to forego surgical axillary staging. Ipsilateral axillary ultrasound showing no lymph node involvement with no evidence of lymphadenopathy or suspicious thickening is required in this scenario
- • No pathological tumor size \> 3 cm or 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 6 months prior to registration
- • Must be intending to take endocrine therapy for at least 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 within 7 days prior to registration
- • Age ≥ 18 years
- • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- * Postmenopausal status confirmed as:
- • No spontaneous menses ≥ 1 year
- • No menses for \< 1 year with follicle stimulating hormone (FSH) and estradiol levels within a postmenopausal range according to institutional standards
- • Previous bilateral surgical oophorectomy
- * None of the following conditions:
- • Abnormal or dysfunctional uterine bleeding within 1 year prior to study enrollment
- • 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.
- • 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 contralateral invasive or non-invasive breast cancer
- • 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 patients with premenopausal status
- • 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
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New Haven, Connecticut, United States
Durham, North Carolina, United States
Buffalo, New York, United States
Saint Louis, Missouri, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Galveston, Texas, United States
Hackensack, New Jersey, United States
Oklahoma City, Oklahoma, United States
Rancho Mirage, California, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Gresham, Oregon, United States
Tualatin, Oregon, United States
Urbana, Illinois, United States
Carroll, Iowa, United States
Dayton, Ohio, United States
Rapid City, South Dakota, United States
Effingham, Illinois, United States
Clearwater, Florida, United States
Springfield, Illinois, United States
San Diego, California, United States
Downers Grove, Illinois, United States
Lowell, Massachusetts, United States
Portland, Oregon, United States
Hazel Crest, Illinois, United States
Summit, New Jersey, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
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Los Angeles, California, United States
Orange, California, United States
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Jacksonville, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Duluth, Minnesota, United States
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Saint Louis, Missouri, United States
Chapel Hill, North Carolina, United States
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Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Amarillo, Texas, United States
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Canton, Ohio, United States
Morgantown, West Virginia, United States
Providence, Rhode Island, United States
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Oakland, California, United States
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Stony Brook, New York, United States
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Decatur, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Cedar Rapids, Iowa, United States
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Brainerd, Minnesota, United States
Los Angeles, California, United States
Freehold, New Jersey, United States
Seneca, Pennsylvania, United States
Princeton, West Virginia, United States
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Fremont, California, United States
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Kansas City, Kansas, United States
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Billings, Montana, United States
Billings, Montana, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
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Franklin, Ohio, United States
Troy, Ohio, United States
Portland, Oregon, United States
Ephrata, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
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Richmond, Virginia, United States
Green Bay, Wisconsin, United States
Mequon, Wisconsin, United States
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Oconomowoc, Wisconsin, United States
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Racine, Wisconsin, United States
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Norwalk, Connecticut, United States
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Saint Helena, California, United States
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Danbury, Connecticut, United States
Moline, Illinois, United States
Hendersonville, North Carolina, United States
Pasadena, California, United States
Honolulu, Hawaii, United States
Grand Junction, Colorado, United States
Torrington, Connecticut, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Fargo, North Dakota, United States
Appleton, Wisconsin, United States
Warrenville, Illinois, United States
Grafton, Wisconsin, United States
Greenville, South Carolina, United States
Carmel, Indiana, United States
Fort Smith, Arkansas, United States
Truckee, California, United States
Dover, Delaware, United States
Post Falls, Idaho, United States
Bloomington, Illinois, United States
Chicago, Illinois, United States
Geneva, Illinois, United States
Pekin, Illinois, United States
Mankato, Minnesota, United States
Saint Louis, Missouri, United States
Manchester, New Hampshire, United States
Barberton, Ohio, United States
Bend, Oregon, United States
Erie, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Boiling Springs, South Carolina, United States
Easley, South Carolina, United States
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Parkersburg, West Virginia, United States
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Racine, Wisconsin, United States
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Franklin, Wisconsin, United States
Oshkosh, Wisconsin, United States
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Fishersville, Virginia, United States
Mukwonago, Wisconsin, United States
Waukesha, Wisconsin, United States
Albuquerque, New Mexico, United States
Trumbull, Connecticut, United States
Overland Park, Kansas, United States
Westwood, Kansas, United States
Kernersville, North Carolina, United States
Mount Airy, North Carolina, United States
Thomasville, North Carolina, United States
Albert Lea, Minnesota, United States
Corvallis, Oregon, United States
Phoenix, Arizona, United States
Winter Haven, Florida, United States
Midlothian, Virginia, United States
Orland Park, Illinois, United States
Rio Rancho, New Mexico, United States
Willow Grove, Pennsylvania, United States
Brewer, Maine, United States
Seattle, Washington, United States
Derby, Connecticut, United States
Fairfield, Connecticut, United States
North Haven, Connecticut, United States
Waterbury, Connecticut, United States
Waterford, Connecticut, United States
Milford, Delaware, United States
Dekalb, Illinois, United States
Manati, Puerto Rico
Greenwich, Connecticut, United States
Saint Petersburg, Florida, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Collierville, Tennessee, United States
Ashland, Wisconsin, United States
Medford, Wisconsin, United States
Newport Beach, California, United States
Clyde, North Carolina, United States
Mechanicsville, Virginia, United States
Wauwatosa, Wisconsin, United States
Farrell, Pennsylvania, United States
Lake Forest, Illinois, United States
Mechanicsburg, Pennsylvania, United States
Libertyville, Illinois, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Tarzana, California, United States
Chilton, Wisconsin, United States
San Juan, Puerto Rico
Bozeman, Montana, United States
Stamford, Connecticut, United States
Barrington, Illinois, United States
Crystal Lake, Illinois, United States
Weaverville, North Carolina, United States
Chambersburg, Pennsylvania, United States
Cranberry Township, Pennsylvania, United States
Monroeville, Pennsylvania, United States
N. Huntingdon, Pennsylvania, United States
New Castle, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Washington, Pennsylvania, United States
Williamsport, Pennsylvania, United States
Baytown, Texas, United States
Houston, Texas, United States
Nassau Bay, Texas, United States
The Woodlands, Texas, United States
Cudahy, Wisconsin, United States
Glastonbury, Connecticut, United States
Westerly, Rhode Island, United States
Vancouver, Washington, United States
Missoula, Montana, United States
Torrance, California, United States
Springfield, Illinois, United States
Shiloh, Illinois, United States
Sheboygan, Wisconsin, United States
Cumberland, Maryland, United States
Buena Park, California, United States
Moon, Pennsylvania, United States
Cameron Park, California, United States
Sheboygan, Wisconsin, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Pontiac, Michigan, United States
San Juan, Puerto Rico
Danville, Illinois, United States
Guilford, Connecticut, United States
Orland Park, Illinois, United States
Greenville, Ohio, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Los Angeles, California, United States
Ames, Iowa, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Osage Beach, Missouri, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Sunset Hills, Missouri, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
Woodbridge, Virginia, United States
Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Rockford, Illinois, United States
Escanaba, Michigan, United States
Saint Joseph, Michigan, United States
Dayton, Ohio, United States
Yorba Linda, California, United States
Sandpoint, Idaho, United States
Irvine, California, United States
Millville, Delaware, United States
Crown Point, Indiana, United States
Camillus, New York, United States
Lafayette, Colorado, United States
Golden, Colorado, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Aurora, Illinois, United States
Brighton, Colorado, United States
Flint, Michigan, United States
Warren, Michigan, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Denver, Colorado, United States
Grosse Pointe Woods, Michigan, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Sheboygan, Wisconsin, United States
Waukee, Iowa, United States
Cherry Hill, New Jersey, United States
Hood River, Oregon, United States
Oak Brook, Illinois, United States
Cypress, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported