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mTOR inhibitor
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
Phase 1 & 2
Waitlist Available
Led By Erica Stringer-Reasor, M.D.
Research Sponsored by University of Alabama at Birmingham
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 collections over 24 hours on day 1 and day 25
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment using three drugs together to treat a specific type of breast cancer in postmenopausal women before surgery. The drugs work by blocking hormones, growth signals, and blood supply to the tumor. The trial involves the use of advanced medications that have been introduced as effective treatments for postmenopausal women with this type of breast cancer.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collections over 24 hours on day 1 and day 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collections over 24 hours on day 1 and day 25
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Experienced Dose-limiting Toxicities
Secondary study objectives
AUC
C Max
Rates of Pathologic Complete Remission (pCR)
+3 moreSide effects data
From 2019 Phase 3 trial • 128 Patients • NCT0297989970%
Epistaxis
67%
Fatigue
67%
Headache
60%
Diarrhea
54%
Nausea
52%
Anemia
41%
Decreased Appetite
40%
Vomiting
38%
Hypertension
37%
Weight Decreased
27%
Gingival Bleeding
25%
Aspartate Aminotransferase Increased
25%
Dyspnea
25%
Stomatitis
24%
Dysgeusia
24%
Alanine Aminotransferase Increased
22%
Hypokalemia
22%
Abdominal Pain
21%
Constipation
21%
Back Pain
21%
Edema Peripheral
17%
Hypothyroidism
17%
Hypotension
17%
Flushing
17%
Pyrexia
16%
Dehydration
16%
Chills
14%
Urinary Tract Infection
14%
Platelet Count Decreased
14%
Hypoalbuminaemia
14%
Lipase Increased
14%
Palmar-Plantar Erythrodysaesthesia Syndrome
13%
Myalgia
13%
Infusion Related Reaction
11%
Asthenia
11%
Mucosal Inflammation
11%
Insomnia
11%
Arthralgia
11%
Mouth Hemorrhage
11%
Blood Alkaline Phosphatase Increased
11%
Lymphocyte Count Decreased
11%
Dizziness
11%
Dyspepsia
11%
Hypomagnesaemia
10%
Dry Mouth
10%
Oral Pain
10%
Blood Thyroid Stimulating Hormone Increased
10%
Vision Blurred
10%
Hyponatraemia
10%
Blood Bilirubin Increased
10%
Anxiety
10%
Abdominal Pain Upper
10%
Embolism
8%
Rash
8%
Telangiectasia
8%
Rash Maculo-Papular
8%
Hypocalcaemia
8%
Cough
8%
Hyperglycemia
8%
Muscle Spasms
8%
Neutrophil Count Decreased
8%
Musculoskeletal Pain
8%
Oropharyngeal Pain
8%
Dysphonia
8%
Fall
8%
Pleural effusion
8%
Pain
6%
Erythema
6%
Hypoxia
6%
White Blood Cell Count Decreased
6%
Chest Pain
6%
Tumor Pain
6%
Musculoskeletal Chest Pain
6%
Disease Progression
6%
Lacrimation Increased
6%
Pruritus
6%
Gingival Pain
6%
Hematemesis
6%
Bradycardia
6%
Nasal Congestion
6%
Migraine
6%
Pain In Jaw
6%
Hyperkalemia
5%
Pain Of Skin
5%
Hematuria
5%
Blood Amylase Increased
5%
Tachycardia
5%
Hyperthyroidism
5%
Oral Dysesthesia
5%
Muscular Weakness
5%
Gastrooesophageal Reflux Disease
5%
Facial Pain
5%
Sinus Tachycardia
5%
Hypophosphatemia
5%
Non-Cardiac Chest Pain
5%
Dry Skin
5%
Blood Creatinine Increased
5%
Alopecia
5%
Hemorrhoids
5%
Proteinuria
5%
Thrombocytopenia
5%
Depression
3%
Flatulence
3%
Pain In Extremity
3%
Wound infection
3%
Hyperbilirubinemia
3%
Abdominal Distension
2%
Subdural Hematoma
2%
Upper Gastrointestinal Hemorrhage
2%
Skin Lesion
2%
Gastrointestinal Hemorrhage
2%
Hyponatremia
2%
Osteomyelitis
2%
Pancreatitis
2%
Rib Fracture
2%
Encephalopathy
2%
Retinal Detachment
2%
Influenza
2%
Meningitis Aseptic
2%
Proctalgia
2%
Tumor Lysis Syndrome
2%
Clavicle Fracture
2%
Bacteremia
2%
Myocardial Infarction
2%
Cardiac Failure
2%
Respiratory Failure
2%
Respiratory Distress
2%
Pneumonitis
2%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
TRC105 + Votrient
Votrient
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment3 Interventions
Letrozole 2.5 mg PO daily until surgery, everolimus 5 or 10 mg PO daily for 24 weeks, and TRC105 15 or 10 mg/kg IV q 2 weeks for 24 weeks. Dose and regimen to be determined based on data from the phase I component.
Group II: Phase I Cohort 2Experimental Treatment3 Interventions
Letrozole 2.5 mg PO daily until surgery, everolimus 10 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks
Group III: Phase I Cohort 1Experimental Treatment3 Interventions
Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks
Group IV: Phase I Cohort -1Experimental Treatment3 Interventions
Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 10 mg/kg IV q 2 weeks for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3590
Everolimus
2010
Completed Phase 4
~1510
TRC105
2016
Completed Phase 3
~280
Find a Location
Who is running the clinical trial?
Tracon Pharmaceuticals Inc.Industry Sponsor
21 Previous Clinical Trials
1,016 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,648 Previous Clinical Trials
2,344,510 Total Patients Enrolled
31 Trials studying Breast Cancer
4,429 Patients Enrolled for Breast Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,916 Previous Clinical Trials
4,253,870 Total Patients Enrolled
87 Trials studying Breast Cancer
37,741 Patients Enrolled for Breast Cancer
Erica Stringer-Reasor, M.D.Principal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
40 Total Patients Enrolled
Erica Stringer-Reasor, MDPrincipal InvestigatorUniversity of Alabama at Birmingham