← Back to Search

Retinoid

Retinoid 9cUAB30 for Early Stage Breast Cancer

Phase 1

Waitlist Available

Led By Helen Krontiras

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky >= 70%

Have not been treated with chemotherapy, or biological therapy in the last 5 years. We do not know if the previous treatment will have an effect on the tissues to be examined.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Awards & highlights

Study Summary

This trial is testing a new drug, 9cUAB30, to see if it is safe and effective in treating early stage breast cancer.

Who is the study for?

This trial is for postmenopausal women or premenopausal women without childbearing potential who have early stage breast cancer. They must not have used certain hormone therapies recently, had chemotherapy or biological therapy in the last 5 years, and should not be on vitamin A supplements. Participants need normal blood counts and organ function tests, and cannot be HIV-positive or have severe psychiatric conditions.Check my eligibility

What is being tested?

The study is testing Retinoid 9cUAB30's effects on early stage breast cancer to see if it can act selectively with fewer side effects than other treatments. It involves surgery to remove the tumor, collection of tissue samples, and administration of the retinoid drug.See study design

What are the potential side effects?

While specific side effects for Retinoid 9cUAB30 are unknown as this is a phase 1b trial aiming to determine them, common retinoid-related side effects may include skin issues like dryness or peeling, headaches, nausea, fatigue, liver enzyme changes and increased sensitivity to sunlight.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am mostly self-sufficient and can carry out daily activities.

Select...

I haven't had chemotherapy or biological therapy in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute change in Ki-67 expression in breast epithelial cells of patients treated with 9cUAB30

Secondary outcome measures

Change in apoptosis in breast epithelial cells of patients treated with 9cUAB30

Change in gene expression of breast cancer samples using a custom gene panel from Nanostring Technologies

Change in maximum concentration (Cmax)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (retinoid 9cUAB30)Experimental Treatment3 Interventions

Patients receive retinoid 9cUAB30 PO QD for 14 to 28 days. Patients then undergo tumor resection surgery. Patients undergo blood and urine sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Biospecimen Collection

2004

Completed Phase 2

~1730