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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 42 months
Awards & highlights

CAPItello-290 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.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.

CAPItello-290 Trial 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.

CAPItello-290 Trial 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

CAPItello-290 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
4,259 Previous Clinical Trials
288,592,979 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are allowed to participate in this experiment at one time?

"Yes, as noted on clinicaltrials.gov, this research is actively recruiting patients. The trial was first posted on 6/25/2019 and updated as recently as 10/10/2022. 924 individuals are needed across 2 locations."

Answered by AI

What are the most common side effects associated with Capivasertib?

"Capivasertib has received a safety score of 3. This is due to the drug being in Phase 3 trials, which means that while there is data supporting efficacy, there are also multiple rounds of data supporting safety."

Answered by AI

Are there any ongoing or past clinical trials that have studied Capivasertib?

"Capivasertib is being trialed in 893 active studies, 237 of which are Phase 3. Many trials for Capivasertib are based in Melbourne, Victoria, however there 49864 total locations running these tests."

Answered by AI

How do I sign up for this research project?

"This study is investigating Triple Negative Breast Neoplasms and thus requires participants who have this neoplasm. The age limit for potential candidates is 18-130 years old, and the clinical trial aims to recruit 924 people in total."

Answered by AI

Are octogenarians precluded from this research?

"If you meet the age requirements (18-130 years old), then you are eligible to participate in this clinical trial."

Answered by AI

Is this experiment still looking for participants?

"The clinicaltrials.gov website suggests that this study is still recruiting patients. The listing was first made on June 25th, 2019 and updated as recently as October 10th, 2020."

Answered by AI

What is the primary indication for Capivasertib?

"Capivasertib is most often used to treat neoplasm metastasis, but it can also be useful in managing kaposi sarcoma, advance directives, and fallopian tubes cancer."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC
2019. "Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03997123.
~161 spots leftby Apr 2025
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