AZD9833 + CDK4/6 Inhibitor for Breast Cancer
(SERENA-6 Trial)

Recruiting in Palo Alto (17 mi)

+241 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

Eligibility Criteria

This trial is for adults with advanced HR-positive, HER2-negative breast cancer that can't be treated with surgery or radiation. Participants must have been on CDK4/6 inhibitors and aromatase inhibitors for at least 6 months without worsening of their cancer and have a detectable ESR1 mutation. They should be able to perform daily activities and not have severe heart disease, certain CNS metastases, uncontrolled diseases, or previous treatment with AZD9833.

Inclusion Criteria

I am 18 years old or older.

My cancer did not worsen after treatment with an AI and CDK4/6 inhibitor.

My advanced breast cancer cannot be treated with surgery or radiation.

+11 more

Exclusion Criteria

My cancer has spread to vital organs and poses an immediate risk to my life.

I do not have active brain metastases or related conditions.

I have lasting side effects from CDK4/6 inhibitor or AI treatment.

+7 more

Participant Groups

The study tests the effectiveness of AZD9833 combined with a CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) against standard treatments using an aromatase inhibitor (anastrozole or letrozole) plus a CDK4/6 inhibitor in patients whose breast cancer has an ESR1 mutation.

2Treatment groups

Experimental Treatment

Active Control

Group I: AZD9833 + palbociclib, abemaciclib or ribociclibExperimental Treatment7 Interventions

The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150,100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (PO, once daily) or letrozole placebo (PO, once daily)

Group II: Anastrozole or letrozole + palbociclib, abemaciclib or ribociclibActive Control7 Interventions

The patients will recieve anastrozole (1 mg, PO, once daily) or letrozole (2.5 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150, 100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: