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Protein Kinase Inhibitor

Drug 1: LY3023414; Drug 2: Prexasertib for Breast Cancer

Phase 2

Waitlist Available

Led By Joyce A O'Shaughnessy, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Off-treatment with steroids for 2 weeks before administration of the first dose of LY3023414 and prexasertib

- No ongoing requirement for dexamethasone or anti-epileptic drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Awards & highlights

Study Summary

This trial is testing two drugs to see if they help people with metastatic triple negative breast cancer.

Eligible Conditions

Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You haven't taken steroids for 2 weeks before starting LY3023414 and prexasertib treatment.

Select...

You cannot be currently taking dexamethasone or anti-seizure medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time that 6 months of progression free survival on study therapy was first met until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. 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)

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT04032080

100%

Nausea

80%

Fatigue

70%

Diarrhea

70%

Vomiting

60%

Headache

60%

Platelet Count Decreased

60%

Anorexia

60%

Oral Pain

50%

Constipation

40%

Neutrophil Count Decreased

40%

Weight Loss

30%

Urinary Tract Infection

30%

Gastroesophageal Reflux Disease (GERD)

30%

Visual Disturbances

30%

Back Pain

20%

Abdominal Pain

20%

Dysuria

20%

Abnormal HBA1C

20%

Muscle Cramping

20%

Influenza

20%

Anemia

20%

Fever

20%

Muscle Pain - Upper Limb

20%

Tremor

20%

Chills

20%

Oral dysesthesia

20%

Upper Respiratory Infection

20%

Insomnia

10%

Toothache

10%

Polyuria

10%

Pneumonitis

10%

Abnormal LVEF

10%

Dry Mouth

10%

Right Clavicular Mass

10%

Cognitive Changes

10%

Neck Pain

10%

Bronchitis

10%

Polydipsia

10%

Febrile neutropenia

10%

Encephalopathy

10%

Pleural effusion

10%

Macular Edema

10%

Axillary Pain

10%

Hemorrhoids

10%

Tachycardia

10%

Chest Wall Pain

10%

Dizziness

10%

Flank Pain

10%

Pneumonia

10%

Muscle Weakness

10%

Axillary Cellulitis

10%

Chest Pressure

10%

Edema Cerebral

10%

Neutrophil count decrease

10%

Dysphagia

10%

Epistaxis

10%

Chest Wall Redness

10%

Hypokalemia

10%

Paresthesia

10%

Dysgeusia

10%

Groin Pain

10%

Hyperglycemia

10%

Thrombocytosis

10%

Alopecia

10%

Leukocytosis

10%

Syncope

10%

Axillary Swelling

10%

Pneumothorax

10%

Localized Edema

10%

Rash

10%

Dyspnea

10%

Edema Limbs

100%

80%

60%

40%

20%

Study treatment Arm

LY3023414 + Prexasertib

Trial Design

1Treatment groups

Experimental Treatment

Group I: LY3023414 + prexasertibExperimental Treatment1 Intervention

Patients with metastatic TNBC who meet the enrollment criteria will receive LY3023414 and prexasertib until disease progression. Patients whose disease does not respond to the combination of LY3023414 and prexasertib may be treated with standard of care breast cancer therapies off study, at the recommendation of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Drug 1: LY3023414; Drug 2: Prexasertib

2019

Completed Phase 2

~10

0 / 2Eligibility criteria met