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Aurora Kinase Inhibitor

Alisertib +/− Fulvestrant for Breast Cancer

Phase 2
Waitlist Available
Led By Tufia C. Haddad, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic proof of metastatic or locally advanced, unresectable breast cancer with history of ER positive (+) (>= 10% of cells positive on H&E), HER2 negative (-) breast cancer disease
Disease that is measurable where: A non-nodal lesion is considered measurable if its longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with CT scan, CT component of a PET/CT, or MRI, A malignant lymph node is considered measurable if its short axis is >= 1.5 cm when assessed by CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new drug, alisertib, to see if it's effective in treating patients with endocrine-resistant breast cancer. Alisertib works by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may also be effective in treating breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.

Who is the study for?
This trial is for post-menopausal women with advanced breast cancer that's resistant to hormone therapy. Participants must have ER positive, HER2 negative tumors and can have had no more than two chemotherapy treatments in the metastatic setting. They should not have taken certain medications recently and must be able to swallow pills.Check my eligibility
What is being tested?
The study is testing alisertib, an enzyme inhibitor thought to slow tumor growth, both alone and combined with fulvestrant, a drug that blocks or reduces estrogen. The goal is to see if one or both drugs together are effective against endocrine-resistant breast cancer.See study design
What are the potential side effects?
Potential side effects of alisertib include fatigue, nausea, diarrhea, blood cell count changes leading to increased infection risk or bleeding problems. Fulvestrant may cause injection site pain, fatigue, nausea and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is advanced, cannot be surgically removed, is ER positive and HER2 negative.
Select...
My cancer can be measured by scans and meets the size requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor response rate defined as 100% times the number of patients who meet the criteria for complete response (CR) or partial response (PR) using RECIST criteria version 1.1
Secondary outcome measures
Biomarkers and ER alpha expression assessed using tumor tissue
Change in blood biomarker levels
Change in tumor biomarker levels
+5 more

Side effects data

From 2017 Phase 2 trial • 178 Patients • NCT02038647
55%
Diarrhoea
47%
Neutropenia
44%
Anaemia
44%
Fatigue
34%
Nausea
33%
Decreased appetite
32%
Vomiting
31%
Stomatitis
24%
Dyspnoea
20%
Cough
17%
Dizziness
16%
Neutrophil count decreased
16%
Alopecia
16%
Asthenia
15%
Weight decreased
14%
Leukopenia
14%
Abdominal pain
14%
White blood cell count decreased
11%
Hypokalaemia
10%
Arthralgia
10%
Febrile neutropenia
10%
Headache
9%
Constipation
9%
Neuropathy peripheral
9%
Pyrexia
9%
Dyspepsia
8%
Thrombocytopenia
8%
Dehydration
8%
Hypocalcaemia
8%
Insomnia
8%
Abdominal pain upper
7%
Muscular weakness
7%
Oedema peripheral
6%
Dysphonia
6%
Hypomagnesaemia
6%
Dysphagia
6%
Gastrooesophageal reflux disease
6%
Fall
6%
Somnolence
6%
Back pain
6%
Hyperglycaemia
6%
Hypertension
5%
Musculoskeletal pain
5%
Hypoaesthesia
5%
Productive cough
5%
Non-cardiac chest pain
5%
Paraesthesia
3%
Epistaxis
3%
Pain in extremity
3%
Respiratory failure
3%
Pneumonia
3%
General physical health deterioration
2%
Pulmonary embolism
2%
Neutropenic sepsis
2%
Dysgeusia
2%
Confusional state
2%
Lung neoplasm malignant
2%
Upper respiratory tract infection
1%
Ataxia
1%
Seizure
1%
Acute respiratory failure
1%
Mental status changes
1%
Pulmonary oedema
1%
Embolism
1%
Pancytopenia
1%
Influenza
1%
Fungal infection
1%
Paraplegia
1%
Oral herpes
1%
Metastases to meninges
1%
Diabetic metabolic decompensation
1%
Aortic thrombosis
1%
Cardiac failure
1%
Acute coronary syndrome
1%
Bacteraemia
1%
Sepsis
1%
Septic shock
1%
Respiratory tract infection
1%
Glioblastoma
1%
Tumour pain
1%
Systemic inflammatory response syndrome
1%
Bile duct stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Paclitaxel
Alisertib + Paclitaxel

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (alisertib, fulvestrant)Experimental Treatment3 Interventions
Patients receive fulvestrant IM over 1-2 minutes on days 1 and 15 of course 1 and on day 1 of all subsequent courses. Patients also receive alisertib PO BID on days 1-3, 8-10, and 15-17. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (alisertib)Experimental Treatment2 Interventions
Patients receive alisertib PO BID on days 1-3, 8-10, and 15-17. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression, may cross-over to Arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Alisertib
2010
Completed Phase 2
~1140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,442 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,095 Total Patients Enrolled
83 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
Tufia C. Haddad, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

Alisertib (Aurora Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02860000 — Phase 2
Breast Cancer Research Study Groups: Arm II (alisertib, fulvestrant), Arm I (alisertib)
Breast Cancer Clinical Trial 2023: Alisertib Highlights & Side Effects. Trial Name: NCT02860000 — Phase 2
Alisertib (Aurora Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02860000 — Phase 2

Frequently Asked Questions

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

How many participants are included in this investigation?

"No longer enrolling patients, this trial was originally advertised on July 6th 2017 and last amended on May 19th 2022. Other potential studies include 2300 breast cancer trials and 139 involving Alisertib that are actively recruiting individuals."

Answered by AI

Has Alisertib received regulatory approval from the FDA?

"The safety of Alisertib has been estimated as 2 out of 3 due to the fact that there is evidence supporting its security, but no clinical data indicating efficacy."

Answered by AI

What ailment is Alisertib primarily used as a therapeutic option for?

"Alisertib is typically prescribed to patients who have already undergone endocrine therapy. Furthermore, the drug can be used to tackle a range of other maladies such as disease, breast cancer and those with pik3ca gene mutations."

Answered by AI

Are individuals currently being enrolled in this clinical trial?

"Per the information posted on clinicaltrials.gov, this research endeavour is currently not recruiting participants. It was initially published on July 6th 2017 and last updated on May 19th 2022. Meanwhile, there are 2439 other studies actively seeking enrollees right now."

Answered by AI

Could you provide a summary of research conducted on Alisertib thus far?

"Alisertib first began to be researched in 2004 at Lowell General Hospital, with 692 studies since concluding. Currently, there are 139 live trials of this medication happening across the US, mainly concentrated in Rochester Minnesota."

Answered by AI

How many research centers are conducting this experiment?

"Mayo Clinic in Rochester, Minnesota, Dana-Farber Cancer Institute in Boston, Massachusetts and Georgetown University Medical Center are three of the sites where patients can enroll for this trial. Additionally there are 8 additional locations taking part."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Illinois
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer
2017. "Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02860000.
~6 spots leftby Apr 2025
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