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AKT Inhibitor

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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
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

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
~5380
Capivasertib
2021
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,623,676 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,437 Patients Enrolled for Breast Cancer
Peter Schmid, MD,PhD,FRCPPrincipal InvestigatorCentre for Experimental Cancer Medicine (CECM), Barts Cancer Institute

Media Library

Capivasertib (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03997123 — Phase 3
Breast Cancer Research Study Groups: Capivasertib + Paclitaxel, Placebo + Paclitaxel
Breast Cancer Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT03997123 — Phase 3
Capivasertib (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997123 — Phase 3
~152 spots leftby Jul 2025