NCT06671912|SuspendedPhase 3

Study Stopped

Amending protocol to increase sample size

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

LoTam

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A012301NCI-2024-06672

Study Type

interventional

Target

1,156

Locations

2 countries

Sites

708

Timeline

RegisteredNov 2024

StartedFeb 2025

CompletionNov 2031

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended

Enrollment

1,156

participants targeted

Target at P75+ for phase_3

Timeline

68mo left

Started Feb 2025

Longer than P75 for phase_3

Geographic Reach

2 countries

708 active sites

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.8 years study duration

Study Progress18%

Feb 2025Nov 2031

First Submitted

Initial submission to the registry

November 1, 2024

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed

4 months until next milestone

Study Start

First participant enrolled

February 19, 2025

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2031

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

5.8 years

First QC Date

November 1, 2024

Last Update Submit

March 2, 2026

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

Outcome Measures

Primary Outcomes (1)

Recurrence-free interval (RFI)
The Kaplan-Meier method will be used to estimate the distribution of RFI times and a stratified log-rank test for non-inferiority will be used to assess whether RFI with low-dose tamoxifen is non-inferior to standard-of-care endocrine therapy in this patient population. Stratified Cox modeling will be used to estimate the hazard ratio and corresponding one-sided 95% confidence interval (CI).
From randomization to the first of the following breast cancer events: invasive ipsilateral breast or chest wall recurrence, regional recurrence, distant recurrence, and death from breast cancer up to 5 years

Secondary Outcomes (8)

Endocrine therapy extent of nonadherence
Up to 5 years
Physician reported incidence of adverse events (AEs)
Up to 10 years
Patient reported toxicities
At baseline and up to 10 years
Invasive disease-free survival (iDFS)
Up to 10 years
Locoregional recurrence free-survival (LRFS)
From randomization until invasive tumor recurs in the ipsilateral breast or chest wall, axillary, supraclavicular, or internal mammary nodes up to 10 years
+3 more secondary outcomes

Study Arms (2)

Arm I (anastrozole, letrozole, exemestane, tamoxifen)

ACTIVE COMPARATOR

Patients receive standard of care endocrine therapy per physician choice with either anastrozole PO, letrozole PO, exemestane PO or standard dose tamoxifen PO QD for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients may also undergo mammogram or MRI, DEXA, and blood sample collection on study.

Drug: AnastrozoleDrug: LetrozoleDrug: ExemestaneDrug: TamoxifenProcedure: MammogramProcedure: Magnetic Resonance ImagingBiological: Dual X-ray AbsorptiometryProcedure: Biospecimen CollectionOther: Questionnaire Administration

Arm II (low dose tamoxifen)

EXPERIMENTAL

Patients receive low-dose tamoxifen PO QOD for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients may also undergo mammogram or MRI, DEXA, and blood sample collection on study.

Drug: TamoxifenProcedure: MammogramProcedure: Magnetic Resonance ImagingBiological: Dual X-ray AbsorptiometryProcedure: Biospecimen CollectionOther: Questionnaire Administration

Interventions

AnastrozoleDRUG

Given PO

Arm I (anastrozole, letrozole, exemestane, tamoxifen)

LetrozoleDRUG

Given PO

Arm I (anastrozole, letrozole, exemestane, tamoxifen)

ExemestaneDRUG

Given PO

Arm I (anastrozole, letrozole, exemestane, tamoxifen)

TamoxifenDRUG

Given PO