Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer

Conditions

• Breast Atypical Hyperplasia
• Breast Carcinoma
• Breast Ductal Carcinoma In Situ
• Breast Lobular Carcinoma In Situ

Eligibility Criteria

Sex

FEMALE

Age

35 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Acolbifene Hydrochloride — DRUG
  Given PO
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Mammography — PROCEDURE
  Undergo 3D mammography
• Questionnaire Administration — OTHER
  Ancillary studies
• Random Periareolar Fine-Needle Aspiration — PROCEDURE
  Undergo RPFNA
• Tamoxifen — DRUG
  Given PO

Study Details

This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.

Key Dates

Start date

Aug 23, 2024

Status verified

Apr 2026

Primary completion

Aug 23, 2027

Completion

Sep 1, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1 (acolbifene)
  Patients receive acolbifene PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D mammography and collection of blood samples during screening and at the end of acolbifene treatment. In addition, patients undergo RPFNA during screening and during day 1-10 of their menstrual cycle, or if not menstruating, at the convenience of the patient and study staff.
• Active Comparator: Group 2 (tamoxifen)
  Patients receive tamoxifen PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D mammography and collection of blood samples during screening and at the end of tamoxifen treatment. In addition, patients undergo RPFNA during screening and day 1-10 of their menstrual cycle, or if not menstruating, at the convenience of the patient and study staff.

Primary Outcome Measure

Change in the relative abundance of the specific sequence of messenger ribonucleic acid that codes for AGR2 [ Time Frame: Baseline up to 6 months ]

Locations (4)

Find similar trials in Duarte, CA

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