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AKT Inhibitor

Capivasertib + Paclitaxel for Breast Cancer (CAPItello-290 Trial)

Phase 3

Waitlist Available

Led By Peter Schmid, MD,PhD,FRCP

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease

Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)

Must not have

Prior systematic therapy for inoperable locally advanced or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately up to 42 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new combination of drugs to treat TNBC compared to the current standard of care.

Who is the study for?

This trial is for adults with advanced or metastatic Triple-negative Breast Cancer (TNBC) who haven't had certain recent treatments. They should be relatively fit, have a tumor sample available, and not planning surgery to remove the cancer. People can't join if they've had specific drugs recently, including chemotherapy within 6 months, AKT/PI3K/mTOR inhibitors, or are experiencing significant neuropathy.

What is being tested?

The study compares Capivasertib combined with Paclitaxel against a placebo plus Paclitaxel in treating TNBC. It's a Phase III trial where patients are randomly assigned to either treatment group as their first line of therapy.

What are the potential side effects?

Capivasertib may cause diarrhea, high blood sugar levels, rash and fatigue. Paclitaxel can lead to hair loss, joint and muscle pain, numbness or tingling in hands and feet (neuropathy), and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured or seen on scans.

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My cancer has spread or returned and cannot be removed with surgery.

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My breast cancer is triple-negative, confirmed by a recent tissue sample.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for cancer that couldn't be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Clinical Benefit Rate (CBR)

Duration of Response (DoR)

EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Capivasertib + PaclitaxelExperimental Treatment2 Interventions

Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.

Group II: Placebo + PaclitaxelPlacebo Group2 Interventions

Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Capivasertib

2021

Completed Phase 1

~130