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LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Early-Stage Breast Cancer

The purpose of this study is to compare the usual treatment with hormonal therapy medications to treatment with low-dose tamoxifen. This study will help the study doctors find out if this different approach is the same as the usual approach. To decide if it is better, the study doctors will be looking to see if low-dose tamoxifen has the same chance of preventing breast cancer from returning compared to the usual hormonal therapy medications with less side effects

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study will involve blood samples, vital signs, physical exams, assessments, mammogram or MRI, Tumor biopsy, EKG/ECG, adverse event assessment and study drug assessment.

Total length of participation:
15 years

Looking for Specific Volunteers

Able to participate:

You are Postmenopausal
You have been diagnosed with unilateral invasive breast adenocarcinoma
You have not received prior treatment for your breast cancer
18 years and female

Not eligible if:

You have experienced Abnormal or dysfunctional uterine bleeding within 1 year
You have a history of breast or thoracic radiotherapy for any previous condition
You have history of ipsilateral invasive breast cancer
You have metastatic breast cancer

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Lisa Carey
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)
Women's Health

IRB Number

25-0585

ClinicalTrials.gov

NCT06671912

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