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Immunosuppressant
Cyclosporin A for Breast Cancer
Phase < 1
Waitlist Available
Led By Virginia Kaklamani, MD, DSc
Research Sponsored by Virginia G. Kaklamani
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage I-III breast cancer will be included that are Estrogen receptor and or progesterone receptor 0-10%, human epidermal growth factor receptor 2 (HER2) negative defined as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP guidelines). HER2 of 2+ on Immunohistochemistry (IHC) should have a ratio of less than 2.0 on fluorescence in situ hybridization (FISH) testing to be considered HER2 negative
Patients must have low or negative RAD51 immunohistochemistry (defined as median <5 foci per nucleus after measuring at least 200 cells)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will study women with a specific type of breast cancer before surgery. Researchers will compare samples taken before surgery with samples taken during surgery to see how the cancer changes over time.
Who is the study for?
This trial is for adults with newly diagnosed triple negative breast cancer showing high levels of DNA damage. Eligible participants must be able to take oral medication, have not started treatment, and cannot be in another drug study. They should be healthy enough for surgery or biopsy after treatment and use effective contraception if childbearing potential.Check my eligibility
What is being tested?
The trial tests Cyclosporin A's effect on biomarkers in patients with triple negative breast cancer before surgery. It's a single-arm study where all participants receive the same intervention without randomization or comparison groups.See study design
What are the potential side effects?
Cyclosporin A can cause side effects like increased risk of infection due to immune system suppression, kidney problems, high blood pressure, liver issues, tremors, and possibly an increase in hair growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is early stage, not driven by estrogen, progesterone, or HER2.
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My cancer cells show low or no RAD51 activity.
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I am eligible for surgery or a repeat biopsy after my treatment.
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I have had a full health check-up in the last 30 days.
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I am able to care for myself and perform daily activities.
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The tissue sample from my first biopsy is available.
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I can take pills by mouth.
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My breast cancer was diagnosed with a needle biopsy and hasn't been treated yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ki67 Expression
Secondary outcome measures
Changes in apoptosis markers
Changes in g-H2Ax
Side effects data
From 2014 Phase 3 trial • 595 Patients • NCT0011477756%
Diarrhoea
53%
Anaemia
50%
Oedema peripheral
43%
Urinary tract infection
35%
Transplant dysfunction
34%
Hypertension
33%
Constipation
30%
Pyrexia
29%
Cough
29%
Nausea
28%
Leukopenia
26%
Hypokalaemia
24%
Nasopharyngitis
23%
Hyperkalaemia
22%
Back pain
22%
Proteinuria
22%
Haematuria
21%
Hypotension
20%
Headache
20%
Vomiting
20%
Bronchitis
20%
Procedural pain
20%
Insomnia
19%
Upper respiratory tract infection
19%
Pain in extremity
19%
Hypocalcaemia
19%
Hyperglycaemia
19%
Hypophosphataemia
18%
Dyspnoea
18%
Dyslipidaemia
18%
Arthralgia
16%
Abdominal pain
16%
Blood creatinine increased
15%
Anxiety
14%
Dysuria
14%
Fatigue
14%
Oedema
14%
Incision site pain
14%
Dizziness
13%
Thrombocytopenia
13%
Asthenia
13%
Hypercalcaemia
12%
Cytomegalovirus infection
12%
Dyspepsia
12%
Chest pain
11%
Hypomagnesaemia
11%
Hypercholesterolaemia
11%
Herpes zoster
11%
Abdominal pain upper
11%
Cataract
10%
Sinusitis
10%
Skin lesion
9%
Muscle spasms
9%
Hyperphosphataemia
9%
Weight decreased
9%
Pruritus
9%
Atrial fibrillation
9%
Influenza
9%
Hyperuricaemia
9%
Haematoma
9%
Tremor
9%
Fall
9%
Acidosis
9%
Renal tubular necrosis
9%
Haemorrhoids
9%
Oropharyngeal pain
8%
Diabetes mellitus
8%
Metabolic acidosis
8%
Tachycardia
8%
Pneumonia
8%
Chronic allograft nephropathy
8%
Conjunctivitis
8%
Leukocytosis
8%
Weight increased
8%
Hyponatraemia
8%
Dyspnoea exertional
8%
Onychomycosis
8%
Oral candidiasis
8%
Decreased appetite
7%
Osteoporosis
7%
Renal impairment
7%
Ecchymosis
7%
Pain
7%
Abdominal distension
7%
Leukocyturia
7%
Erectile dysfunction
7%
Pyelonephritis
7%
Musculoskeletal pain
7%
Dehydration
7%
Oral herpes
7%
C-reactive protein increased
7%
Hyperlipidaemia
7%
Neutropenia
6%
Myalgia
6%
Skin papilloma
6%
Paraesthesia
6%
Fluid overload
6%
Rhinitis
5%
Escherichia urinary tract infection
5%
Hydronephrosis
5%
Productive cough
5%
Cardiac failure congestive
5%
Aphthous stomatitis
5%
Hypoglycaemia
5%
Bradycardia
5%
Complications of transplanted kidney
5%
Lymphocele
5%
Lymphopenia
5%
Chills
5%
Basal cell carcinoma
5%
Peripheral swelling
5%
Gastrooesophageal reflux disease
5%
Osteopenia
4%
Deep vein thrombosis
4%
Sinus bradycardia
4%
Acne
4%
Gastroenteritis
4%
Renal failure acute
4%
Ligament sprain
4%
Sciatica
4%
Squamous cell carcinoma of skin
4%
Myocardial infarction
4%
Sepsis
4%
Contusion
4%
Gastritis
4%
Hyperparathyroidism
4%
Hyperkeratosis
4%
Depression
4%
Blood pressure increased
4%
Fungal skin infection
3%
Urinary retention
3%
Neck pain
3%
Left ventricular hypertrophy
3%
Nasal congestion
3%
Angina pectoris
3%
Renal vein thrombosis
3%
Urosepsis
3%
Cellulitis
3%
Respiratory tract infection
3%
Flatulence
3%
Cushingoid
3%
Cerebrovascular accident
3%
Vertigo
2%
Pyelonephritis acute
2%
Transient ischaemic attack
2%
Muscular weakness
2%
Squamous cell carcinoma
2%
Abscess
2%
Wound dehiscence
2%
Wound complication
2%
Osteomyelitis
2%
Ureteric stenosis
2%
Arteriosclerosis coronary artery
2%
Polyomavirus-associated nephropathy
2%
Arthritis
2%
Skin ulcer
2%
Bowen's disease
2%
Graft loss
2%
Sudden death
2%
Bacteraemia
2%
Graft complication
2%
Postoperative wound infection
2%
Polycythaemia
2%
Arteriovenous fistula thrombosis
2%
Gout
2%
Pulmonary oedema
2%
Pulmonary tuberculosis
2%
Cardiac failure
2%
Pneumocystis jirovecii pneumonia
2%
Gangrene
2%
Gastric ulcer
1%
Road traffic accident
1%
Phlebitis
1%
Acute myocardial infarction
1%
Hypercoagulation
1%
Osteoarthritis
1%
Ischaemic cardiomyopathy
1%
Oral fungal infection
1%
Cytomegalovirus colitis
1%
Thrombosis
1%
Respiratory distress
1%
Wound evisceration
1%
Erosive oesophagitis
1%
Duodenitis
1%
Cytomegalovirus hepatitis
1%
Hepatic mass
1%
Hypertensive crisis
1%
Urinary tract infection enterococcal
1%
Peripheral artery stenosis
1%
Bladder prolapse
1%
Supraventricular tachyarrhythmia
1%
Chronic obstructive pulmonary disease
1%
Diverticular perforation
1%
Mycoplasma infection
1%
Obstructive uropathy
1%
Post procedural urine leak
1%
Progressive multifocal leukoencephalopathy
1%
Small intestinal obstruction
1%
Anal abscess
1%
Cytomegalovirus viraemia
1%
Diabetic bullosis
1%
Enterocolitis haemorrhagic
1%
Ureteral necrosis
1%
Vaginal haemorrhage
1%
Acute pulmonary oedema
1%
Adverse drug reaction
1%
Cryptococcosis
1%
Device related infection
1%
Renal haemorrhage
1%
Hypovolaemia
1%
Varicella
1%
Mediastinal disorder
1%
Pleural effusion
1%
Pseudomonal sepsis
1%
Pneumonia cryptococcal
1%
Colon cancer metastatic
1%
Cytomegalovirus syndrome
1%
Urinary tract infection bacterial
1%
Urinary incontinence
1%
Ventricular extrasystoles
1%
Cerebral ischaemia
1%
Confusional state
1%
Shunt occlusion
1%
Venous thrombosis limb
1%
Septic shock
1%
Diabetic foot
1%
Cerebral haemorrhage
1%
Renal artery thrombosis
1%
Hyperparathyroidism tertiary
1%
Necrotising fasciitis
1%
Vesicoureteric reflux
1%
Renal artery dissection
1%
Atrial flutter
1%
Toxicity to various agents
1%
Gastroduodenal ulcer
1%
Arterial stenosis
1%
Escherichia sepsis
1%
Lower gastrointestinal haemorrhage
1%
Macular oedema
1%
Post procedural haematoma
1%
Haemorrhage
1%
Femur fracture
1%
Abdominal hernia
1%
Abdominal pain lower
1%
Abscess limb
1%
Benign prostatic hyperplasia
1%
Non-cardiac chest pain
1%
Oesophagitis
1%
Appendicitis
1%
Urinary tract obstruction
1%
Uveitis
1%
Urinary tract infection pseudomonal
1%
Acute respiratory distress syndrome
1%
Aortic valve stenosis
1%
Pancreatitis acute
1%
Aortic valve disease
1%
Clostridium difficile colitis
1%
Guillain-Barre syndrome
1%
Perinephric collection
1%
Tachyarrhythmia
1%
Coronary artery disease
1%
Joint tuberculosis
1%
Localised infection
1%
Postrenal failure
1%
Aspiration
1%
Intestinal obstruction
1%
Mobility decreased
1%
Tinea versicolour
1%
Fistula
1%
Ventricular tachycardia
1%
Tooth abscess
1%
Thrombophlebitis superficial
1%
Gastroenteritis viral
1%
Hepatitis
1%
Cardio-respiratory arrest
1%
Erysipelas
1%
Haemorrhage intracranial
1%
Kaposi's sarcoma
1%
Meningitis cryptococcal
1%
Ileus
1%
Incision site complication
1%
Lymphangitis
1%
Muscle rupture
1%
Rectal adenocarcinoma
1%
Synovitis
1%
Urinary fistula
1%
BK virus infection
1%
Cardiogenic shock
1%
Cerebral aspergillosis
1%
Cholangitis
1%
Chorioretinitis
1%
Diverticulum
1%
Hepatic cyst infection
1%
Hydrocele
1%
Hypercreatinaemia
1%
Intestinal perforation
1%
Leishmaniasis
1%
Lower respiratory tract infection
1%
Meniscus injury
1%
Metrorrhagia
1%
Oesophageal candidiasis
1%
Perirenal haematoma
1%
Pulmonary embolism
1%
Volvulus
1%
Adenocarcinoma
1%
Blood creatine increased
1%
Bronchopneumopathy
1%
Cardiac arrest
1%
Hypoxic-ischaemic encephalopathy
1%
Intestinal fistula
1%
Lung infection
1%
Neurotoxicity
1%
Osteonecrosis
1%
Overdose
1%
Post procedural complication
1%
Renal infarct
1%
Tendon rupture
1%
Asthma
1%
B-cell lymphoma
1%
Cerebral fungal infection
1%
Complications of transplant surgery
1%
Dysentery
1%
Emphysematous cystitis
1%
Epilepsy
1%
Gastric ulcer haemorrhage
1%
Intraductal proliferative breast lesion
1%
Lobar pneumonia
1%
Muscle haemorrhage
1%
Pancreatic carcinoma
1%
Perirectal abscess
1%
Post procedural haemorrhage
1%
Respiratory tract infection fungal
1%
Sinusitis bacterial
1%
Staphylococcal bacteraemia
1%
Suicide attempt
1%
Umbilical hernia
1%
Wound infection
1%
Bacterial pyelonephritis
1%
Convulsion
1%
Cytomegalovirus enteritis
1%
Diabetic gangrene
1%
Diverticulum intestinal haemorrhagic
1%
Dupuytren's contracture
1%
Electrolyte imbalance
1%
Haemoptysis
1%
Klebsiella infection
1%
Microalbuminuria
1%
Multi-organ failure
1%
Myocardial ischaemia
1%
Non-Hodgkin's lymphoma
1%
Pneumonia aspiration
1%
Pneumothorax
1%
Plasma cell myeloma
1%
Pneumonia bacterial
1%
Renal cell carcinoma
1%
Renal tubular disorder
1%
Vascular graft complication
1%
White blood cells urine positive
1%
Acute coronary syndrome
1%
Acute psychosis
1%
Arrhythmia
1%
Arrhythmia supraventricular
1%
Arteriovenous fistula aneurysm
1%
Central nervous system lymphoma
1%
Cholangiocarcinoma
1%
Cholangitis acute
1%
Colitis
1%
Cystitis bacterial
1%
Cytomegalovirus gastrointestinal infection
1%
Diverticulitis
1%
Encephalomyelitis
1%
Epididymitis
1%
Epiglottic carcinoma
1%
Helicobacter gastritis
1%
Hepatic cyst
1%
Hip fracture
1%
International normalised ratio increased
1%
Lung cancer metastatic
1%
Lung disorder
1%
Nephropathy
1%
Nephropathy toxic
1%
Partial seizures
1%
Prostatitis
1%
Scrotal oedema
1%
Duodenal ulcer
1%
Brain mass
1%
Extravasation
1%
Gallbladder perforation
1%
Graft thrombosis
1%
Oral disorder
1%
Pancreatitis
1%
Platelet count decreased
1%
Prerenal failure
1%
Prostate cancer
1%
Renal artery stenosis
1%
Respiratory arrest
1%
Shock
1%
Visual acuity reduced
1%
Prostatism
1%
Ureteric obstruction
1%
Post procedural discharge
1%
Hypertriglyceridaemia
1%
Mitral valve stenosis
1%
Ischaemic stroke
1%
Decubitus ulcer
1%
Peripheral arterial occlusive disease
1%
Bronchopneumonia
1%
Psoas abscess
1%
Ureteric fistula
1%
Staphylococcal sepsis
1%
Intestinal ischaemia
1%
Renal transplant failure
1%
Aspergillus infection
1%
Renal failure
1%
Adenocarcinoma of colon
1%
Agranulocytosis
1%
Pancytopenia
1%
Abscess rupture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept More Intensive (MI) Regimen
Belatacept Less Intensive (LI) Regimen
Cyclosporin (CsA)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cyclosporin AExperimental Treatment1 Intervention
Patients with newly diagnosed triple negative breast cancer with low or negative RAD51 (A protein coding gene that provides instructions for making a protein that is essential for repairing damaged DNA)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclosporin A
2015
Completed Phase 3
~2270
Find a Location
Who is running the clinical trial?
Virginia G. KaklamaniLead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Virginia Kaklamani, MD, DScPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are eligible patients able to enroll in this ongoing trial at the present time?
"Information from clinicaltrials.gov shows that this particular research endeavor is currently not actively seeking volunteers. The study's initial posting was on March 1, 2024, with the latest update made on January 30, 2024. Despite its closure for recruitment, it's worth noting that there are a noteworthy total of 2379 ongoing studies actively searching for eligible participants at present."
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