AZD9833 Combinations for Advanced Breast Cancer
(SERENA-1 Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byRichard Baird, MD PhD FRCP

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)

Eligibility Criteria

This trial is for women with advanced breast cancer that's ER positive and HER2 negative. They must be over 18, have had no more than two chemo treatments for advanced disease, and not be on certain drugs or have specific health issues like uncontrolled hypertension or severe systemic diseases. Participants need to agree to contraception if of childbearing potential.

Inclusion Criteria

My cancer has spread or returned and doesn't respond to current treatments.

My cancer is estrogen receptor positive.

My cancer is not HER2 positive.

+13 more

Exclusion Criteria

I do not have severe illnesses like uncontrolled high blood pressure, active bleeding disorders, or infections like hepatitis or HIV.

My heart's pumping ability is below normal, or I've had specific heart procedures or conditions in the last 6 months.

My blood pressure is not controlled by medication.

+15 more

Participant Groups

The study tests AZD9833 alone or combined with other drugs (capivasertib, abemaciclib, ribociclib, anastrozole, palbociclib, everolimus) in different groups to find the best treatment for this type of breast cancer. It's a Phase 1 trial focusing on dosage safety and effectiveness.

14Treatment groups

Experimental Treatment

Group I: AZD9833 with ribociclib (± anastrozole) dose expansionExperimental Treatment1 Intervention

Group II: AZD9833 with ribociclib (± anastrozole) dose escalationExperimental Treatment1 Intervention

Group III: AZD9833 with palbociclib dose expansionExperimental Treatment1 Intervention

Group IV: AZD9833 with palbociclib dose escalationExperimental Treatment1 Intervention

Group V: AZD9833 with everolimus dose expansionExperimental Treatment1 Intervention

Group VI: AZD9833 with everolimus dose escalationExperimental Treatment1 Intervention

Group VII: AZD9833 with capivasertib dose expansionExperimental Treatment1 Intervention

Group VIII: AZD9833 with capivasertib dose escalationExperimental Treatment1 Intervention

Group IX: AZD9833 with anastrozole dose expansionExperimental Treatment1 Intervention

Group X: AZD9833 with anastrozole dose escalationExperimental Treatment1 Intervention