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Anti-cancer Agent

pharmacological study for Breast Cancer

N/A

Waitlist Available

Led By Peter Conti, MD

Research Sponsored by University of Southern California

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 up to 1 year

Awards & highlights

Study Summary

This trial looks at the side effects of PET/CT scans to see if they can predict how well patients will respond to chemotherapy for breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Change of FMAU-PET score vs. change of Ki-67 from the baseline to post-chemotherapy

Incidence of adverse events

Secondary outcome measures

Incidence of Adverse Events

Side effects data

From 2020 Phase 1 & 2 trial • 88 Patients • NCT02012296

82%

Fatigue

45%

Hot flashes

42%

Anorexia

39%

Constipation

27%

Pain

27%

Generalized muscle weakness

21%

Back pain

18%

Diarrhea

18%

Headache

18%

Hypertension

18%

Dizziness

18%

Nausea

15%

Weight loss

15%

Arthralgia

15%

Upper respiratory infection

12%

Abdominal pain

12%

Memory impairment

12%

Peripheral sensory neuropathy

12%

Hematuria

12%

Vomiting

12%

Fall

12%

Pain in extremity

12%

Urinary frequency

Dyspnea

Pelvic pain

Hyperglycemia

General disorders and administration site conditions - Other

Anxiety

Edema limbs

White blood cell decreased

Breast pain

Alopecia

Ear pain

Flank pain

Urinary incontinence

Renal and urinary disorders - Other

Investigations - Other

Cystitis noninfective

Fracture

Hypokalemia

Weight gain

Watering eyes

Paresthesia

Neoplasms benign, malignant and unspecified

Flu like symptoms

Arthritis

Bone pain

Cough

Urinary retention

Neutrophil count decreased

Small intestinal obstruction

Depression

Dyspepsia

Platelet count decreased

Confusion

Ileus

Skin and subcutaneous tissue disorders - Other

Skin infection

Non-cardiac chest pain

Blurred vision

Muscle weakness lower limb

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Enzalutamide, Mifepristone)

Treatment (Enzalutamide)

Not Randomized

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (fluorine F 18-clevudine PET/CT)Experimental Treatment5 Interventions

Patients receive fluorine F18-clevudine IV over 1 minute and then undergo PET/CT scan at baseline. Patients with HER2+ breast cancer also undergo fluorine F 18-clevudine PET/CT scan 2-3 weeks after the first course of treatment and after completion of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

positron emission tomography/computed tomography

2013

Completed Phase 2

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,266 Total Patients Enrolled

12 Trials studying Breast Cancer

4,544 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,655 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Peter Conti, MDPrincipal InvestigatorUniversity of Southern California

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers currently seeking participants for this research study?

"The data located on clinicaltrials.gov reveals that this trial is in search of participants; the initial posting was dated November 22nd 2013 and recently revised on August 6th 2022."

Answered by AI

What is the current participation rate in this clinical trial?

"Affirmative. Clinicaltrials.gov lists this trial as currently welcoming prospects, with the original posting date being November 22nd 2013 and most recent amendment on August 6th 2022. This research project is searching for 25 individuals from one medical site to partake in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

2013. "PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01712815.