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AKT Inhibitor

Capivasertib + Fulvestrant for Advanced Breast Cancer (CAPItello-291 Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor
Patients are to have received treatment with an AI (aromatase inhibitor) containing regimen and have radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, or radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 51 months
Awards & highlights

CAPItello-291 Trial Summary

This trial is testing a new cancer drug to see if it is more effective than current treatments for women with breast cancer that has spread.

Who is the study for?
This trial is for adults with advanced HR+/HER2- breast cancer that's inoperable or metastatic, and who've seen their cancer progress after AI therapy. It's open to both men and women, including pre-menopausal women willing to take LHRH agonists. Participants should have a good performance status (ECOG/WHO PS: 0-1) and not have had more than one chemotherapy or two endocrine therapies for advanced disease.Check my eligibility
What is being tested?
The study compares the effectiveness of capivasertib plus fulvestrant against placebo plus fulvestrant in treating advanced breast cancer. This Phase III trial randomly assigns participants to either treatment group while keeping both patients and researchers unaware of which treatment is being administered (double-blind).See study design
What are the potential side effects?
Potential side effects include reactions related to hormone therapy such as hot flashes, injection site pain from fulvestrant, and possible effects from capivasertib like diarrhea, rash, fatigue or changes in blood sugar levels. The severity can vary among individuals.

CAPItello-291 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is hormone receptor positive and HER2 negative.
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My breast cancer progressed while on or after AI treatment.
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I am an adult willing to undergo hormone therapy if pre-menopausal.
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My cancer has spread or worsened and cannot be surgically removed with the aim of curing it.
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I have cancer that can be measured by scans or I have a certain type of bone lesion.
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I am fully active and can carry on all my pre-disease activities without restriction.

CAPItello-291 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 51 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
Progression-Free Survival (PFS) in the overall population and in the PIK3CA/AKT1/PTEN-altered subgroup
Secondary outcome measures
Clinical Benefit Rate (CBR) in the overall population and in the PIK3CA/AKT1/PTEN-altered subgroup.
Duration of Response (DoR) in the overall population and in the PIK3CA/AKT1/PTEN-altered subgroup.
EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module) in the overall population and in the PIK3CA/AKT1/PTEN-altered subgroup where applicable
+7 more

Side effects data

From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803
50%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
NASOPHARYNGITIS
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
PNEUMONIA
10%
ARTHRALGIA
10%
NAUSEA
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
HYPOCALCAEMIA
10%
LYMPHOCYTE COUNT DECREASED
10%
DRY MOUTH
10%
PLATELET COUNT DECREASED
10%
HYPERKALAEMIA
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
DYSPEPSIA
10%
HYPERTRIGLYCERIDAEMIA
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
HERPES ZOSTER
10%
INFLUENZA
10%
CONTUSION
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant

CAPItello-291 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Capivasertib + fulvestrantExperimental Treatment2 Interventions
Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Capivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.
Group II: Placebo + fulvestrantPlacebo Group2 Interventions
Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Placebo: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3700
Capivasertib
2021
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,241 Previous Clinical Trials
288,521,322 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer

Media Library

Capivasertib (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04305496 — Phase 3
Breast Cancer Research Study Groups: Capivasertib + fulvestrant, Placebo + fulvestrant
Breast Cancer Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT04305496 — Phase 3
Capivasertib (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305496 — Phase 3

Frequently Asked Questions

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

Does this experiment involve any minors?

"According to the inclusion criteria for this study, patients aged 18-130 are eligible to apply. There are 67 clinical trials specifically for minors and 2440 research studies available for adults over 65 years old."

Answered by AI

What are the main goals that researchers hope to achieve with this clinical trial?

"The goal of this study is to improve Progression-Free Survival (PFS) in patients with cancer. Additionally, the study will measure Duration of Response (DoR), Response Rate (ORR), and Time to definitive deterioration of the ECOG performance status."

Answered by AI

Are new participants being recruited for this trial at this time?

"The clinicaltrials.gov website confirms that this study is still looking for eligible patients. The listing was first created on April 16th, 2020 and edited most recently on October 3rd, 2022."

Answered by AI

Has Capivasertib received FDA regulatory approval?

"Capivasertib's safety is estimated to be a 3. This score was given because capivasertib is in Phase 3 of clinical trials, which suggests that there is some evidence supporting the efficacy of the drug as well as multiple rounds of data collected on its safety profile."

Answered by AI

What other experiments have there been with Capivasertib?

"Out of the 157 clinical trials currently underway for Capivasertib, 35 are in Phase 3. Some of these tests are happening in Shanghai, but there are 9683 total locations worldwide where researchers are running clinical trials for Capivasertib."

Answered by AI

What is the primary disease or condition that Capivasertib is designed to improve?

"Capivasertib is often used to treat patients that have undergone endocrine therapy. Additionally, this medication can be given to those suffering from disease, breast cancer, and pik3ca gene mutation."

Answered by AI

To whom is this research project available?

"This trial is looking for 834 patients with locally advanced (inoperable) or metastatic breast cancer. The ages of the participants must fall between 18 and 130, and they must meet the following criteria: Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study"

Answered by AI
~166 spots leftby Mar 2025