Duavee for Breast Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen bySwati Kulkarni, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a treatment on women with early-stage breast cancer to see if it can reduce cancer risk by changing specific signs in breast tissue.

Research Team

Swati Kulkarni, MD

Principal Investigator

Northwestern University

Eligibility Criteria

Postmenopausal women aged 18-79 with newly diagnosed ER (+) DCIS of the breast, scheduled for surgery. Participants must be able to swallow pills, sign consent forms, and have normal organ/marrow function. Excluded are those on certain drugs, with invasive breast cancer or other serious conditions like blood clots or active second cancers.

Inclusion Criteria

I am a woman with a new ER+ DCIS diagnosis planning for surgery.

The size of the DCIS on the imaging meets the standards set by the hospital.

My cancer's growth markers are similar to those in a specific breast condition.

See 9 more

Exclusion Criteria

You have had allergic reactions to similar medicines as CE/BZA.

You cannot take any other experimental medications. If you were taking one before, you need to stop for at least 4 weeks before you can join the study.

I have another active cancer besides non-melanoma skin cancer.

See 7 more

Treatment Details

Interventions

Conjugated Estrogens/Bazedoxifene (Hormone Therapy)
Placebo (Other)

Trial OverviewThe PROMISE Study tests if Duavee (conjugated estrogens/bazedoxifene), approved for menopause symptoms but not for DCIS in postmenopausal women, affects breast tissue markers and is safe. It includes a placebo group and examines quality-of-life impacts through questionnaires.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (conjugated estrogens/bazedoxifene)Experimental Treatment5 Interventions

Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Group II: Arm II (placebo)Placebo Group5 Interventions

Patients receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.