AZD9833 vs Fulvestrant for Advanced Breast Cancer
(SERENA-2 Trial)

Recruiting in Palo Alto (17 mi)

+78 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial compares a new pill (AZD9833) with an existing injection for treating advanced breast cancer in post-menopausal women. It targets women with a specific type of breast cancer that relies on estrogen to grow. Both treatments work by blocking estrogen receptors to slow down or stop cancer growth.

Eligibility Criteria

This trial is for post-menopausal women aged at least 18 with advanced ER-positive HER2-negative breast cancer. They must have had recurrence or progression after endocrine therapy, possibly including CDK4/6 inhibitors, and no more than one chemotherapy for advanced disease. No prior fulvestrant/SERD treatment, good performance status (ECOG/WHO 0-1), and measurable disease are required.

Inclusion Criteria

My cancer returned or worsened after endocrine therapy.

I have had only one hormone therapy for my advanced disease.

I am fully active or can carry out light work.

+8 more

Exclusion Criteria

My cancer has spread to vital organs or my brain and is not under control.

I haven't had extensive radiation therapy recently.

My bone marrow or organs are not functioning well.

+10 more

Participant Groups

The study compares the effectiveness and safety of a new oral drug called AZD9833 against an existing intramuscular drug named Fulvestrant in treating advanced breast cancer. It's a Phase 2 trial where participants are randomly assigned to either treatment group.

4Treatment groups

Experimental Treatment

Active Control

Group I: AZD9833 Dose CExperimental Treatment1 Intervention

The patients will receive AZD9833 (Dose C).

Group II: AZD9833 Dose BExperimental Treatment1 Intervention

The patients will receive AZD9833 (Dose B).

Group III: AZD9833 Dose AExperimental Treatment1 Intervention

The patients will receive AZD9833 (Dose A).

Group IV: Fulvestrant 500 mgActive Control1 Intervention

The patients will receive Fulvestrant (500 mg).