CLINICAL TRIAL

Alisertib for Breast Cancer

Locally Advanced
Metastatic
Newly Diagnosed
Waitlist Available · 18+ · Female · Rochester, MN

This study is evaluating whether alisertib with or without fulvestrant is better at treating patients with endocrine-resistant breast cancer that has spread to other places in the body.

See full description

About the trial for Breast Cancer

Eligible Conditions
Carcinoma Breast Stage IV · Breast Cancer, Stage IIIB · Stage IIIA Breast Cancer · HER2/Neu Negative · Breast Cancer, Stage III · Breast Neoplasms · Invasive Breast Carcinoma · Estrogen Receptor Status · Breast Cancer Stage IIIc · Postmenopausal

Treatment Groups

This trial involves 2 different treatments. Alisertib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Laboratory Biomarker Analysis
OTHER
+
Alisertib
DRUG
+
Fulvestrant
DRUG
Experimental Group 2
Laboratory Biomarker Analysis
OTHER
+
Alisertib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alisertib
Not yet FDA approved
Fulvestrant
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Breast Cancer or one of the other 9 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
PRE-REGISTRATION ELIGIBILITY
History of ER positive (+) (>= 10% of cells positive on hematoxylin and eosin stain [H&E]), HER2 negative (-) breast cancer disease, either as a
Prior treatment
Age >= 60 and amenorrhea > 12 consecutive months, OR Age < 60 and amenorrhea > 12 consecutive months without another cause and documented follicle stimulating hormone (FSH) level of > 35 mIU/mL, OR Previous bilateral oophorectomy
Histologic proof of metastatic or locally advanced, unresectable breast cancer
History of primary, operable ER+/HER2- invasive breast cancer OR History of de novo metastatic breast cancer that is ER+/HER2-
HER2 immunohistochemistry (IHC) expression of 0, 1+ and in-situ hybridization (ISH) non-amplified
HER2 IHC expression of 0, 1+ and ISH not done
HER2 IHC expression of 2+ and ISH non-amplified
IHC not done and ISH non-amplified
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Alisertib will improve 1 primary outcome and 8 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 4 weeks.

Biomarkers and ER alpha expression assessed using tumor tissue
UP TO 4 WEEKS
Spearman rank correlation coefficient will be used to examine the association between ER alpha expression and the biomarkers: CD44, CD24, total and phosphorylated expression of AURKA, SMAD5, and SOX2. A two sample test of the difference in proportions will be used to examine whether weak or no phosphorylated expression of AURKA, SMAD5, and SOX2 after one cycle of alisertib is associated with clinical benefit (CR + PR + stable disease on treatment for at least 6 months).
UP TO 4 WEEKS
Clinical benefit rate (CBR) during initial treatment defined as proportion of patients who completed 6 courses of treatment without documentation of disease progression
AT 24 WEEKS
For initial treatment in each arm, the CBR at 24 weeks will be defined as the proportion of patients who completed 6 cycles of treatment without documentation of disease progression. A 90% confidence interval for the CBR will be constructed using the Duffy-Santner approach to take into account the sequential nature of the study design.
AT 24 WEEKS
Change in tumor biomarker levels
BASELINE TO 28 DAYS
Spearman rank correlation coefficient will be used to examine the association of maximum percentage of tumor shrinkage during treatment with the percent change after 1 cycle of treatment in aurora A Kinase (AAK) expressing cells, as well as percent changes after 1 cycle of treatment in tissue ER alpha, SMAD5, SOX2 expression and phosphorylation.
BASELINE TO 28 DAYS
Change in blood biomarker levels
BASELINE TO 28 DAYS
Percent change in CTC expression of aurora A kinase, ER, and phospho- SOX2 expression from pre-treatment levels will be determined for each patient. Bland-Altman plots and weighted kappa statistics will be used to examine the concordance between the percent change in aurora A kinase, ER, and phospho-SOX2 expression from pre-treatment levels in CTC and in tumor tissue.
BASELINE TO 28 DAYS
Incidence of adverse events graded by Common Terminology Criteria-Criteria for Adverse Events (CTCAE) version 4.0
UP TO 30 DAYS AFTER LAST ADMINISTRATION OF STUDY DRUG
The CTCAE version 4.0 will be used to grade and assign attribution to each adverse event reported during initial treatment and crossover treatment separately.
UP TO 30 DAYS AFTER LAST ADMINISTRATION OF STUDY DRUG
Progression-free survival
TIME FROM RANDOMIZATION TO THE FIRST OF THESE DISEASE EVENTS: LOCAL/REGIONAL OR DISTANT BREAST RECURRENCE, DCIS OR INVASIVE BREAST DISEASE IN CONTRALATERAL BREAST, NON-BREAST SECOND PRIMARY, OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 5 YEARS
Will be estimated using the Kaplan-Meier method.
TIME FROM RANDOMIZATION TO THE FIRST OF THESE DISEASE EVENTS: LOCAL/REGIONAL OR DISTANT BREAST RECURRENCE, DCIS OR INVASIVE BREAST DISEASE IN CONTRALATERAL BREAST, NON-BREAST SECOND PRIMARY, OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 5 YEARS
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Patient Q & A Section

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

Can breast cancer be cured?

The main purpose of mastectomy is to eliminate the cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The most effective prevention options are still unavailable, especially early detection (e.g. mammography and more frequent breast self-examinations), and smoking cessation. If breast cancer is diagnosed early enough, good treatments are available to greatly reduce cancer progression, though not cure. However, more research to find the most effective ways to achieve mammography and smoking cessation and the most effective treatments for breast cancer is necessary.

Anonymous Patient Answer

What are common treatments for breast cancer?

For most women, breast self-examination (BSE) and receipt of a mammogram before the age of 50 remain the best preventive measures for breast cancer. It is important to emphasize that BSE is not a complete solution and should only be employed as a strategy to reduce breast cancer risk, and not be a substitute for more aggressive screening. The effectiveness of screening other family members is unclear.

Anonymous Patient Answer

How many people get breast cancer a year in the United States?

It is estimated that around 2.5 million women would have had [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the United States in 1999 if the age-adjusted cancer incidence rates observed in these age groups in 1999 had been the same in 1999 as in 1999 in 1997. It would be expected that the age-adjusted breast cancer rates would have fallen between 1997 and 1999 by the same proportion as the age-adjusted colorectal cancer rates have fallen between 1997 and 1999, but the current rate has remained constant, suggesting that the rates of breast cancer are increasing, possibly because of increased numbers of diagnosed cases, or increased life expectancy, or both.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is the most common cause of a woman to be diagnosed with cancer and the incidence of breast cancer is expected to increase. The National Centre for Disease Control identifies breast cancer as the top cause of death among women in the United States of America.

Anonymous Patient Answer

What causes breast cancer?

Women of Northern Europe and Western Europe are at lowest risk, and the highest observed risk occurs in South Asians. Low mammographic densities cause higher rates of breast cancer in the developed world. The major risk factors are family history and female sex.

Anonymous Patient Answer

What are the signs of breast cancer?

Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) are often of a sudden onset. Signs include pain, hard or lumpy feelings in the breast or changes in the shape and position of the breast. Fever, general malaise or weight loss may occur. If lumpiness, redness or a painful feeling is only experienced after the breast exam is complete, further test should be undertaken. Breast pain may also develop in the course of the disease. Symptoms are often preceded by a feeling of a lump in the breast or in a part of the body.

Anonymous Patient Answer

What is alisertib?

In this preliminary study, a low incidence of side effects as nausea, vomiting and fatigue, together with good tolerability, was observed. However, a larger cohort of patients to confirm these findings should be developed.

Anonymous Patient Answer

How serious can breast cancer be?

Even for early Stage I breast cancer, the chance of a recurrence persists for at least 24 months. However, the 5-year survival rate remains high, with a value ranging between 59.6% and 77.4% depending on the method of analysis of the prognosis in the early stage. For the advanced stages, it is in spite of any treatment, the 5- year survival rate decreases over the years to about 20%; 5 years survival exceeds 15% for patients who received all adjuvant therapies but remains low for metastatic patients or those treated surgically after neoadjuvant chemotherapy.

Anonymous Patient Answer

Is alisertib safe for people?

At the dose of 12.5 mg/day there was no relevant safety adverse event. Therefore, patients should be treated as per their safety in phase III clinical trials.

Anonymous Patient Answer

Does alisertib improve quality of life for those with breast cancer?

In a recent study, findings suggest a substantial QoL benefit, in terms of better appetite, insomnia, and other symptoms of fatigue, in women treated with alisertib 40 mg/ daily.

Anonymous Patient Answer

Has alisertib proven to be more effective than a placebo?

The most common adverse events with both doses and alisertib were fatigue and abdominal pain, which may have been an off-target effect of alisertib. Compared with other drugs used in breast cancer, alisertib has a unique benefit of increasing the percentage of tumor shrinkage. Recent findings of this randomized Phase II study suggest that alisertib is a promising therapy for treatment of breast cancer.

Anonymous Patient Answer

What are the common side effects of alisertib?

The most common side effects of alisertib were fatigue (75 %), nausea (70 %) and constipation (45 %). More than half of the patients (51 %) experienced an objective response to alisertib as evidenced by a decrease in tumor burden and grade of the tumor. Fatigue and nausea were found to be the most common reasons for termination of treatment (54 % and 43 % respectively).

Anonymous Patient Answer
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