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Genomically Directed Monotherapy for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Bryan Schneider, MD
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 from c1d1 until death or up to a maximum of 60 months
Awards & highlights
Study Summary
This trial will test if personalized therapy for each individual's tumor will be more effective than the current standard of care.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from c1d1 until death or up to a maximum of 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death or up to a maximum of 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Two-Year Disease-Free Survival (DFS)
Secondary outcome measures
Comparison Between One Year Disease Free Survival
Comparison Between Overall Disease-Free Survival
Five-Year Overall Survival (OS) Rate
+1 moreSide effects data
From 2022 Phase 2 trial • 193 Patients • NCT0210138551%
FATIGUE
32%
NAUSEA
28%
DIARRHEA
21%
CONSTIPATION
18%
BACK PAIN
17%
HEADACHE
14%
DYSPNEA
13%
HYPERTENSION
13%
ANOREXIA
13%
COUGH
13%
NEUTROPHIL COUNT DECREASED
13%
PERIPHERAL SENSORY NEUROPATHY
11%
ARTHRALGIA
10%
VOMITING
8%
ANEMIA
8%
ALKALINE PHOSPHATASE INCREASED
8%
RASH ACNEIFORM
8%
PLATELET COUNT DECREASED
7%
DYSPEPSIA
7%
MUCOSITIS ORAL
7%
MYALGIA
6%
HYPOTHYROIDISM
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
INSOMNIA
6%
PAIN
6%
PAIN IN EXTREMITY
6%
PRURITUS
6%
HOT FLASHES
6%
DYSGEUSIA
6%
HYPERGLYCEMIA
4%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
4%
DIZZINESS
4%
ABDOMINAL PAIN
4%
BLURRED VISION
4%
CHEST WALL PAIN
4%
LYMPHOCYTE COUNT DECREASED
4%
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
4%
WHITE BLOOD CELL DECREASED
4%
ANXIETY
4%
NASAL CONGESTION
4%
URINARY TRACT INFECTION
3%
WEIGHT LOSS
3%
PNEUMONITIS
3%
LYMPHEDEMA
3%
BREAST INFECTION
3%
ORAL PAIN
3%
FEBRILE NEUTROPENIA
3%
CREATININE INCREASED
3%
EDEMA LIMBS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
HYPOALBUMINEMIA
3%
INFECTIONS AND INFESTATIONS
3%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
3%
WEIGHT GAIN
3%
ALANINE AMINOTRANSFERASE INCREASED
3%
BREAST PAIN
3%
FLU LIKE SYMPTOMS
3%
SKIN ULCERATION
3%
SKIN INFECTION
1%
EDEMA FACE
1%
NAIL INFECTION
1%
VAGINAL INFECTION
1%
VAGINAL INFLAMMATION
1%
ALOPECIA
1%
WOUND DEHISCENCE
1%
HYPERCALCEMIA
1%
SORE THROAT
1%
HYPERTHYROIDISM
1%
FEVER
1%
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
1%
HOARSENESS
1%
HYPERHIDROSIS
1%
DRY SKIN
1%
DERMATITIS RADIATION
1%
HYPOKALEMIA
1%
ALLERGIC RHINITIS
1%
BONE PAIN
1%
DYSPHAGIA
1%
CHOLECYSTITIS
1%
DEPRESSION
1%
DYSESTHESIA
1%
FACIAL PAIN
1%
FALL
1%
NAIL LOSS
1%
GENERALIZED MUSCLE WEAKNESS
1%
HEMORRHOIDS
1%
LOCALIZED EDEMA
1%
LEUKOCYTOSIS
1%
IRRITABILITY
1%
MEMORY IMPAIRMENT
1%
MUCOSAL INFECTION
1%
MUSCLE WEAKNESS TRUNK
1%
NECK PAIN
1%
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
1%
ORAL DYSESTHESIA
1%
TELANGIECTASIA
1%
PRESYNCOPE
1%
PARESTHESIA
1%
PELVIC PAIN
1%
PERIPHERAL MOTOR NEUROPATHY
1%
PERSONALITY CHANGE
1%
PLEURAL EFFUSION
1%
SINUSITIS
1%
SUPERFICIAL SOFT TISSUE FIBROSIS
1%
UPPER RESPIRATORY INFECTION
1%
AGITATION
1%
LUNG INFECTION
1%
BLOOD BILIRUBIN INCREASED
1%
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
1%
BRACHIAL PLEXOPATHY
1%
EPISTAXIS
1%
FLASHING LIGHTS
1%
ALLERGIC REACTION
1%
FLUSHING
1%
HYPONATREMIA
1%
PAPULOPUSTULAR RASH
1%
PERIORBITAL EDEMA
1%
PSYCHIATRIC DISORDERS
1%
SINUS PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Genomically Directed Monotherapy)
Control Arm B (Observation/Standard Therapy)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Control Arm B (Observation/Standard Therapy)Experimental Treatment1 Intervention
Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Group II: Arm A (Genomically Directed Monotherapy)Experimental Treatment1 Intervention
Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). Clinical and laboratory monitoring and dose-reductions will follow the FDA package insert guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Genomically Directed Monotherapy
2014
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Strategic Research Initiative Grant through IUSCCUNKNOWN
Walther Cancer InstituteOTHER
24 Previous Clinical Trials
1,009 Total Patients Enrolled
2 Trials studying Breast Cancer
87 Patients Enrolled for Breast Cancer
Bryan Schneider, MDLead Sponsor
1 Previous Clinical Trials
197 Total Patients Enrolled
1 Trials studying Breast Cancer
197 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You don't have any serious infections, as decided by your doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Genomically Directed Monotherapy)
- Group 2: Control Arm B (Observation/Standard Therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to join this experiment?
"Clinicaltrials.gov reveals that this experiment is not actively recruiting right now, though it was initially posted on April 3rd 2014 and last updated on August 30th 2022. Nevertheless, over 4 thousand other clinical trials are looking for participants currently."
Answered by AI
Does the FDA recognize Genomically Directed Monotherapy as a viable treatment option?
"Based on the available data, Genomically Directed Monotherapy was assigned a score of 2. This evaluation is based upon Phase 2 trial results which demonstrate some safety but lack efficacy evidence."
Answered by AI
How many healthcare facilities in North America are offering this research trial?
"Participants of this medical trial are able to select from 29 sites located throughout the United States. While Gainesville, Washington and Anderson host clinical trials, there is likely a site near you that can minimize your travel requirements."
Answered by AI
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