RECRUITING

Testing Low Dose Tamoxifen for Invasive Breast Cancer, the (LoTam) Trial

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Conditions

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage 1 Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-04-15
Study Completion:2031-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06671912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral invasive adenocarcinoma of the breast that is histologically confirmed
  2. * Invasive breast cancer is estrogen receptor positive in ≥ 10% of cells
  3. * HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
  4. * 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):
  5. * Oncotype DX recurrence score ≤ 25
  6. * Mamma Print low risk
  7. * Prosigna risk of recurrence ≤ 40
  8. * Tumor size must be ≤ 3 cm by pathologic evaluation
  9. * 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
  10. * 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
  11. * Surgical axillary staging (sentinel lymph node biopsy ± axillary lymph node dissection) is completed according to physician discretion
  12. * 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
  13. * No pathological tumor size \> 3 cm or pT4
  14. * No definitive clinical or radiologic evidence of metastatic disease
  15. * 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
  16. * No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast, unless biopsied and found to be benign
  17. * An interval of no more than 20 weeks between the date of surgery and the date of registration
  18. * Must have had a bilateral mammogram or MRI within 6 months prior to registration
  19. * Must be intending to take endocrine therapy for at least 5 years duration
  20. * 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.)
  21. * No use of oral hormone replacement therapy within 7 days prior to registration
  22. * Age ≥ 18 years
  23. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  24. * Postmenopausal status confirmed as:
  25. * No spontaneous menses ≥ 1 year
  26. * No menses for \< 1 year with follicle stimulating hormone (FSH) and estradiol levels within a postmenopausal range according to institutional standards
  27. * Previous bilateral surgical oophorectomy
  28. * None of the following conditions:
  29. * Abnormal or dysfunctional uterine bleeding within 1 year prior to study enrollment
  30. * 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.
  31. * 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
  32. * 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
  33. * No previous history of ipsilateral invasive breast cancer or ipsilateral ductal carcinoma in situ (DCIS), regardless of the disease-free interval
  34. * No synchronous or previous contralateral invasive or non-invasive breast cancer
  35. * 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
  36. * No patients with premenopausal status
  37. * 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
  38. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jack Beranek
CONTACT
773-702-9171
breastprotocols@alliancenctn.org

Study Locations (Sites)

Keck Medicine of USC Buena Park
Buena Park, California, 90621
United States
Enloe Medical Center
Chico, California, 95926
United States
Kaiser Permanente Dublin
Dublin, California, 94568
United States
Kaiser Permanente-Fremont
Fremont, California, 94538
United States
Kaiser Permanente-Fresno
Fresno, California, 93720
United States
Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Kaiser Permanente-Modesto
Modesto, California, 95356
United States
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
Kaiser Permanente-Roseville
Roseville, California, 95661
United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115
United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
United States
Kaiser Permanente San Leandro
San Leandro, California, 94577
United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161
United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589
United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904
United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
United States
Kaiser Permanente-Capitol Hill Medical Center
Washington, District of Columbia, 20002
United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
Mary Greeley Medical Center
Ames, Iowa, 50010
United States
McFarland Clinic - Ames
Ames, Iowa, 50010
United States
McFarland Clinic - Boone
Boone, Iowa, 50036
United States
Mercy Hospital
Cedar Rapids, Iowa, 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland, 21244
United States
Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland, 20879
United States
Kaiser Permanente - Largo Medical Center
Largo, Maryland, 20774
United States
Kaiser Permanente Lutherville - Timonium Medical Center
Lutherville, Maryland, 21093
United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Community Medical Center
Missoula, Montana, 59804
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
United States
Women and Infants Hospital
Providence, Rhode Island, 02905
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
United States
MD Anderson in The Woodlands
Conroe, Texas, 77384
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
MD Anderson West Houston
Houston, Texas, 77079
United States
MD Anderson League City
League City, Texas, 77573
United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
United States
Kaiser Permanente Tysons Corner Medical Center
McLean, Virginia, 22102
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
United States
Kaiser Permanente-Caton Hill Medical Center
Woodbridge, Virginia, 22192
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
United States
Sheboygan Phyisicans Group
Sheboygan, Wisconsin, 53081
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2031-11-30

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2031-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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