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Protein Kinase Inhibitor
Afuresertib + Fulvestrant for Breast Cancer
Phase 3
Recruiting
Research Sponsored by Laekna Limited
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
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
Must not have
Patients who have a history of seizure or conditions that may predispose them to seizure and require anti-epileptic medications, or patients who have brain arteriovenous malformation, or intracranial masses
Patients who have Child-Pugh status of B and C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase i: through study completion for an average of 12 months
Awards & highlights
Pivotal Trial
Summary
This trial tests a combination of two drugs, afuresertib and fulvestrant, for patients with a specific type of breast cancer who haven't responded to other treatments. The drugs work together to block cancer cell growth by targeting different pathways. Fulvestrant is an effective drug used for treating hormone receptor-positive, HER2-negative advanced breast cancer, often in combination with other targeted therapies.
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.
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.
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 belowSelect...
My breast cancer is positive for hormone receptors and negative for HER2.
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I am fully active or can carry out light work.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures or conditions that may lead to seizures, or I have brain arteriovenous malformation or intracranial masses.
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My liver disease is moderately to severely advanced.
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I am a woman who can have children and my pregnancy test before the study was positive.
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I haven't had serious heart problems or blood clots in the last 6 months.
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I am currently taking medication that strongly affects liver enzymes.
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I have an active Hepatitis B or C infection.
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My high blood pressure is not under control.
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I have previously been treated with medications targeting estrogen receptors or specific cancer growth pathways.
Select...
I have active brain metastases or carcinomatous meningitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase i: through study completion for an average of 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase i: through study completion for an average of 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I: Overall Response Rate (ORR) based on RECIST 1.1
Phase III: Progression Free Survival (PFS) based on RECIST 1.1, as assessed by investigators
Secondary study objectives
Phase I: Best Overall Response (BOR) based on RECIST 1.1
Phase I: Disease Control Rate (DCR) based on RECIST 1.1
Phase I: Duration of Response (DOR) based on RECIST 1.1
+8 moreSide effects data
From 2021 Phase 3 trial • 693 Patients • NCT0202850773%
Palmar-plantar erythrodysesthesia syndrome
58%
Fatigue
56%
Diarrhea
38%
Hypertension
38%
Nausea
30%
Mucositis
29%
Vomiting
26%
Weight loss
26%
Weight gain
24%
Anorexia
20%
Nail disorder
17%
Back pain
16%
Hypothermia
15%
Constipation
15%
Abdominal pain
14%
Neutrophil count decreased
13%
Dizziness
13%
Upper respiratory infection
13%
Headache
11%
Dyspepsia
10%
Pain in extremity
10%
Fever
10%
Obesity
10%
Dysgeusia
9%
Arthralgia
9%
Bone pain
9%
Anemia
8%
Cough
8%
Pruritus
7%
Flu like symptoms
6%
Pain
4%
Alopecia
2%
Thromboembolic event
2%
Bone fracture
1%
Gastrointestinal infection
1%
Spinal cord compression
1%
Febrile neutropenia
1%
Respiratory infection
1%
Hot flashes
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 and 2: Capecitabine
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1: Palbociclib Plus Exemestane
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase III: afuresertib combined with fulvestrant (experimental arm)Experimental Treatment1 Intervention
Phase III: afuresertib 125mg QD combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)
Group II: Phase I: Afuresertib and Fulvestrant Safety Run InExperimental Treatment1 Intervention
Phase I: 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 III: Phase I: Afuresertib and FulvestrantExperimental Treatment1 Intervention
Phase I: 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.
Group IV: Phase III:placebo combined with fulvestrant (control arm)Placebo Group1 Intervention
PhaseIII:placebo combined with fulvestrant 500mg Q4W (D1, 15 in cycle 1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afuresertib
2020
Completed Phase 2
~180
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Breast cancer treatments often target specific pathways involved in cancer cell growth and survival. AKT inhibitors, like Afuresertib, block the AKT signaling pathway, which is crucial for cell proliferation and survival, thereby inducing cancer cell death.
Estrogen receptor antagonists, such as Fulvestrant, bind to estrogen receptors on cancer cells, blocking estrogen from stimulating cancer growth. This is particularly important for hormone receptor-positive breast cancers.
Other common treatments include aromatase inhibitors, which reduce estrogen production, and HER2 inhibitors, which target the HER2 protein overexpressed in some breast cancers. Understanding these mechanisms helps tailor treatments to the specific characteristics of a patient's cancer, potentially improving outcomes and minimizing side effects.
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial.An Experimental Analysis of the Molecular Effects of Trastuzumab (Herceptin) and Fulvestrant (Falsodex), as Single Agents or in Combination, on Human HR+/HER2+ Breast Cancer Cell Lines and Mouse Tumor Xenografts.A Phase I Trial of BKM120 (Buparlisib) in Combination with Fulvestrant in Postmenopausal Women with Estrogen Receptor-Positive Metastatic Breast Cancer.
Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial.An Experimental Analysis of the Molecular Effects of Trastuzumab (Herceptin) and Fulvestrant (Falsodex), as Single Agents or in Combination, on Human HR+/HER2+ Breast Cancer Cell Lines and Mouse Tumor Xenografts.A Phase I Trial of BKM120 (Buparlisib) in Combination with Fulvestrant in Postmenopausal Women with Estrogen Receptor-Positive Metastatic Breast Cancer.
Find a Location
Who is running the clinical trial?
Laekna LimitedLead Sponsor
7 Previous Clinical Trials
353 Total Patients Enrolled
Laekna LLCLead Sponsor
Wenyue MaStudy DirectorLaekna Limited
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor thinks you will live for at least 24 weeks.My breast cancer is positive for hormone receptors and negative for HER2.I have a history of seizures or conditions that may lead to seizures, or I have brain arteriovenous malformation or intracranial masses.My liver disease is moderately to severely advanced.My breast cancer is hormone receptor positive and HER2 negative.I haven't had major surgery or used IV antibiotics for an infection in the last 6 and 2 months, respectively.I am 18 years or older and can provide my own consent.I have recovered from side effects of my previous treatments to a mild level.I am a post-menopausal woman or I am pre-/peri-menopausal and willing to undergo ovarian suppression therapy.I agree to use birth control during and for 3 months after the study.I am fully active or can carry out light work.Your heart's electrical activity takes longer than normal to recharge.I am a woman who can have children and my pregnancy test before the study was positive.I will use effective birth control during and for 4 months after the study.I haven't had serious heart problems or blood clots in the last 6 months.I am currently taking medication that strongly affects liver enzymes.You have tested positive for HIV with certain criteria.I have an active Hepatitis B or C infection.I agree to tests for specific genetic changes in my cancer.I have waited the required time after my last cancer treatment before starting a new one.I can safely receive fulvestrant treatment.I have other cancers that are growing or needed treatment in the last 3 years.My high blood pressure is not under control.My blood, kidney, liver, clotting ability, and sugar levels are all within normal ranges.I can swallow pills and don't have stomach issues affecting medication absorption.I have previously been treated with medications targeting estrogen receptors or specific cancer growth pathways.I have active brain metastases or carcinomatous meningitis.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I: Afuresertib and Fulvestrant Safety Run In
- Group 2: Phase I: Afuresertib and Fulvestrant
- Group 3: Phase III: afuresertib combined with fulvestrant (experimental arm)
- Group 4: Phase III:placebo combined with fulvestrant (control arm)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.