Capivasertib + Fulvestrant for Breast Cancer

(SAFE-CAP Trial)

Overseen By Laura Kane

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Maryam Lustberg

Must be taking: LHRH agonists

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Diabetes, Brain metastases, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 26

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone receptor-positive (HR+), HER2-negative advanced breast cancer who are eligible for this treatment regimen.

Who Is on the Research Team?

Maryam Lustberg, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I have metastatic breast cancer with a PIK3CA, AKT1, or PTEN gene change.

I am fully active or have minor symptoms and expect to live at least 12 weeks.

Exclusion Criteria

I do not have any conditions that prevent me from absorbing medications properly.

Clinically significant abnormalities of glucose metabolism.

I have not had major surgery or serious injury in the past 4 weeks and do not expect surgery soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive capivasertib and fulvestrant with prophylactic strategies to mitigate rash and diarrhea

8 weeks

Every 14 days for fulvestrant administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

Every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Capivasertib

How Is the Trial Designed?

Group I: Rash prophylaxis Experimental Treatment 3 Interventions

All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants will take cetirizine 10 mg orally once daily, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days).

Group II: Rash and diarrhea prophylaxis Experimental Treatment 4 Interventions

All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants in this arm will take cetirizine 10 mg orally once daily, and loperamide 2 mg orally once daily on capivasertib dosing days, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days).

Who Is Running the Clinical Trial?

Maryam Lustberg

Lead Sponsor

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology