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Protein Kinase Inhibitor

Afuresertib + Fulvestrant for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by Laekna LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically or cytologically confirmed HR+/HER2- BC characterized by the absence of HER2 expression and the presence of ER and/or PR expression
HR+/HER2- BC patients must meet all the specified criteria to join this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion for an average of 12 months
Awards & highlights

Study Summary

This trial is testing a new combination therapy for patients with breast cancer who have failed 1-2 other treatments.

Who is the study for?
This trial is for adults with HR+/HER2- advanced or metastatic breast cancer who've had certain prior treatments. Participants must be post-menopausal or on ovarian suppression therapy, have a good performance status and life expectancy, and agree to use contraception. They can't join if they have heart issues, seizures, other serious health conditions, are pregnant/breastfeeding, or have used specific drugs recently.Check my eligibility
What is being tested?
The study tests the combination of afuresertib plus fulvestrant in patients whose breast cancer hasn't responded well to previous therapies. It's designed to see if this combo is effective and safe compared to standard treatments.See study design
What are the potential side effects?
While not specified here, common side effects may include reactions at the injection site from fulvestrant, gastrointestinal issues from oral medications like afuresertib, fatigue, possible liver function changes and potential hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is positive for hormone receptors and negative for HER2.
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My breast cancer is hormone receptor positive and HER2 negative.
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I am 18 years or older and can provide my own consent.
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I have recovered from side effects of my previous treatments to a mild level.
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I am a post-menopausal woman or I am pre-/peri-menopausal and willing to undergo ovarian suppression therapy.
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I agree to use birth control during and for 3 months after the study.
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I am fully active or can carry out light work.
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I will use effective birth control during and for 4 months after the study.
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I agree to tests for specific genetic changes in my cancer.
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I have waited the required time after my last cancer treatment before starting a new one.
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I can safely receive fulvestrant treatment.
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My blood, kidney, liver, clotting ability, and sugar levels are all within normal ranges.
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I can swallow pills and don't have stomach issues affecting medication absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion for an average of 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion for an average of 12 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 Response Rate (ORR) based on RECIST 1.1
Secondary outcome measures
Best Overall Response (BOR) based on RECIST 1.1
Disease Control Rate (DCR) based on RECIST 1.1
Duration of Response (DOR) based on RECIST 1.1
+4 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%
NAUSEA
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
LYMPHOCYTE COUNT DECREASED
10%
PNEUMONIA
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Afuresertib and Fulvestrant Safety Run InExperimental Treatment1 Intervention
Safety run-in Cycle 1 (a cycle is 28 days) will be performed in the first 6 patients of the phase Ib. Combination regimens during the safety run-in period are: afuresertib 125 mg QD (once daily) or 125 mg Day1-21 Q4W + fulvestrant 500 mg or 250 mg Intra Muscular (IM) on Day 1, 15 of Cycle 1, and on Day 1 of the subsequent 28-day cycles.
Group II: Afuresertib and FulvestrantExperimental Treatment1 Intervention
Combination regimens are: afuresertib 125 mg QD (once daily) or 125 mg Day1-21 Q4W + fulvestrant 500 mg or 250 mg Intra Muscular (IM) on Day 1, 15 of Cycle 1, and on Day 1 of the subsequent 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afuresertib
2014
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Laekna LLCLead Sponsor
Xiaoyu Wang, MDStudy DirectorLaekna Limited

Media Library

Afuresertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04851613 — Phase 1
Breast Cancer Research Study Groups: Afuresertib and Fulvestrant Safety Run In, Afuresertib and Fulvestrant
Breast Cancer Clinical Trial 2023: Afuresertib Highlights & Side Effects. Trial Name: NCT04851613 — Phase 1
Afuresertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851613 — Phase 1

Frequently Asked Questions

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

Are researchers presently recruiting participants for this experiment?

"Affirmative, the clinicaltrials.gov database unveils that this experiment is actively seeking applicants. It was first advertised on February 18th 2022 and later edited on May 17th 2022. The research requires 20 participants at 6 different sites for completion."

Answered by AI

Has Afuresertib been granted official sanction by the Food and Drug Administration?

"Due to the limited clinical data available, our team at Power has assigned Afuresertib a safety score of 1. This is because this particular drug is currently in Phase One trials and there are few studies that demonstrate its efficacy or security."

Answered by AI

How many test sites are conducting this experiment?

"This clinical trial has 6 sites enrolling patients, including Providence St. Johns Health Center in Santa Monica and Piedmont Cancer Institute in Atlanta. Additionally, University of Iowa in Iowa City is also participating along with 3 other medical centres around the country."

Answered by AI

What maladies has Afuresertib been proven to address effectively?

"Afuresertib is usually employed to address pik3ca gene mutation, but it can also have a positive effect on malignant neoplasms, disease progression and those who have undergone prior endocrine treatment."

Answered by AI

Are there any prior research initiatives that have utilized Afuresertib?

"Afuresertib was initially investigated in 2004 at Lowell General Hospital, and since then 97 studies have been concluded. At present 135 trials are being conducted with a significant proportion taking place out of Santa Monica, California."

Answered by AI

How many individuals are presently participating in this clinical investigation?

"To commence this medical trial, 20 appropriate individuals must be recruited. Participants can join from various locations including Providence St. Johns Health Center in Santa Monica and University of Iowa in Iowa City."

Answered by AI
~6 spots leftby Mar 2025