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Aurora Kinase Inhibitor

Tak-228 & Tak-117 for Breast Cancer

Phase 2
Waitlist Available
Led By Joyce O'Shaughnessy, MD
Research Sponsored by Joyce O'Shaughnessy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2 years 8 months
Awards & highlights

Study Summary

This trial is testing two new drugs to see if they can help treat metastatic triple negative breast cancer when used with cisplatin and nab paclitaxel.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2 years 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years 8 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
Efficacy (Objective Response Rate)
Secondary outcome measures
Efficacy (Duration of Response)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0".
Number of Treatment-Emergent Adverse Events (Safety and Tolerability)

Side effects data

From 2022 Phase 2 trial • 12 Patients • NCT03193853
90%
Nausea
90%
Fatigue
70%
Diarrhea
50%
Upper Respiratory Infection
50%
Neuropathy in Lower Extremities
50%
Stomatitis
40%
Back Pain
40%
Cough
40%
Fever
30%
Chest Wall Pain
30%
Tinnitus
30%
Anemia
30%
Hyperglycemia
30%
Insomnia
30%
Rash
30%
Leg Cramps
30%
Dizziness
20%
Axilla Pain
20%
Congestion
20%
Myalgia
20%
Alopecia
20%
Transaminitis
20%
Urinary Tract Infection
20%
Dehydration
20%
Cervicalgia
20%
Blurred Vision
20%
Weight Loss
20%
Neuropathy
20%
Neuropathy in Upper Extremities
20%
Strep Throat
20%
Pleural Effusion
20%
Dysgeusia
20%
Dyspnea
20%
Earache
20%
Hoarseness
10%
Acute Respiratory Failure
10%
Ictericia
10%
Vision Changes
10%
Shoulder Pain
10%
Shingles
10%
Transient ischemic attack
10%
Bronchitis
10%
Abdominal Pain
10%
Sepsis
10%
Tremors
10%
Vitamin D Deficiency
10%
Acute Renal Failure
10%
Hypokalemia
10%
Vomiting
10%
Bacterial Vaginosis
10%
Bone Pain
10%
Viral Gastroenteritis
10%
Hyperopia
10%
Increased Forgetfulness
10%
Lethargy
10%
Pruritus
10%
Scalp Tenderness
10%
Shin Pain
10%
Sore Throat
10%
Thrombus
10%
Jaw Pain
10%
Renal Injury
10%
Decreased Appetite
10%
Dry Throat
10%
Dysphagia
10%
Dysphonia
10%
Folliculitis
10%
Hot Flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tak + Cisplatin and Nab Paclitaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tak + cisplatin and nab paclitaxelExperimental Treatment2 Interventions
Patients with metastatic TNBC who meet the enrollment criteria will receive TAK-228 and TAK-117 until disease progression followed by nab paclitaxel plus cisplatin for six cycles. Patients who did not progress may continue nab paclitaxel under treating physicians discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin & Nab Paclitaxel
2017
Completed Phase 2
~20
Tak-228 & Tak-117
2017
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Joyce O'ShaughnessyLead Sponsor
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,214 Total Patients Enrolled
4 Trials studying Breast Cancer
250 Patients Enrolled for Breast Cancer
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,178,024 Total Patients Enrolled
3 Trials studying Breast Cancer
3,780 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are there previous cases of Tak-228 & Tak-117 being used in a medical capacity?

"As of now, 1390 studies are being conducted on Tak-228 & Tak-117. Of these active studies, 439 are in Phase 3 testing. The vast majority of trials for Tak-228 & Tak-117's efficacy are based in Shanghai; however, there 77259 locations worldwide where this treatment is being tested."

Answered by AI

What are Tak-228 & Tak-117 typically prescribed for?

"Tak-228 & Tak-117 have been clinically shown to be effective at treating non-small cell lung carcinoma (nsclc), neoplasm metastasis, and kaposi sarcoma."

Answered by AI

What is the official governmental stance on Tak-228 & Tak-117?

"While there is some evidence indicating that Tak-228 & Tak-117 are safe, as this is only a Phase 2 trial, Power rates the safety of these drugs as a 2."

Answered by AI

How many patients are participating in this clinical trial?

"This study is not currently enrolling patients but was last updated on May 25th, 2022. There are 2439 other trials for triple negative breast neoplasms and 1390 for Tak-228 & Tak-117 that are looking for participants if you're interested."

Answered by AI

Are patients being recruited for this trial at this time?

"The clinical trial in question, which can be found on clinicaltrials.gov, is not currently recruiting patients. This particular study was last updated on May 25th, 2022 and originally posted on July 18th, 2017. There are 3,829 other trials that are actively recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer
Joyce O'Shaughnessy 2017. "TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03193853.
~2 spots leftby Apr 2025
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