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Immunosuppressant

Cyclosporin A for Breast Cancer

Phase < 1
Recruiting
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)
Must not have
Hepatic impairment as judged by clinical investigator or bilirubin >2
Current use of specified medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
My breast cancer is early stage, not driven by estrogen, progesterone, or HER2.
Select...
My cancer cells show low or no RAD51 activity.
Select...
I am eligible for surgery or a repeat biopsy after my treatment.
Select...
I have had a full health check-up in the last 30 days.
Select...
I am able to care for myself and perform daily activities.
Select...
The tissue sample from my first biopsy is available.
Select...
I can take pills by mouth.
Select...
My breast cancer was diagnosed with a needle biopsy and hasn't been treated yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My liver isn't working well, or my bilirubin level is above 2.
Select...
I am currently taking certain medications.
Select...
My high blood pressure is not under control.
Select...
I am not receiving chemotherapy before surgery for triple-negative breast cancer.
Select...
I have been diagnosed with inflammatory breast cancer.
Select...
My kidney function is significantly reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ki67 Expression
Secondary study objectives
Changes in apoptosis markers
Changes in g-H2Ax

Side effects data

From 2014 Phase 3 trial • 595 Patients • NCT00114777
56%
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%
Hypercholesterolaemia
11%
Hypomagnesaemia
11%
Herpes zoster
11%
Abdominal pain upper
11%
Cataract
10%
Skin lesion
10%
Sinusitis
9%
Muscle spasms
9%
Pruritus
9%
Hyperphosphataemia
9%
Influenza
9%
Atrial fibrillation
9%
Weight decreased
9%
Hyperuricaemia
9%
Haematoma
9%
Tremor
9%
Fall
9%
Acidosis
9%
Renal tubular necrosis
9%
Haemorrhoids
9%
Oropharyngeal pain
8%
Tachycardia
8%
Diabetes mellitus
8%
Metabolic acidosis
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%
Hydronephrosis
5%
Escherichia urinary tract infection
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%
Sinus bradycardia
4%
Renal failure acute
4%
Gastroenteritis
4%
Deep vein thrombosis
4%
Acne
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%
Left ventricular hypertrophy
3%
Neck pain
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%
Wound complication
2%
Transient ischaemic attack
2%
Wound dehiscence
2%
Pyelonephritis acute
2%
Abscess
2%
Squamous cell carcinoma
2%
Muscular weakness
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%
Venous thrombosis limb
1%
Mycoplasma infection
1%
Post procedural urine leak
1%
Urinary tract infection bacterial
1%
Enterocolitis haemorrhagic
1%
Urinary incontinence
1%
Hypertensive crisis
1%
Mediastinal disorder
1%
Pneumonia cryptococcal
1%
Duodenitis
1%
Cytomegalovirus colitis
1%
Cerebral ischaemia
1%
Device related infection
1%
Necrotising fasciitis
1%
Bladder prolapse
1%
Erosive oesophagitis
1%
Pseudomonal sepsis
1%
Peripheral artery stenosis
1%
Supraventricular tachyarrhythmia
1%
Vesicoureteric reflux
1%
Confusional state
1%
Cytomegalovirus hepatitis
1%
Shunt occlusion
1%
Anal abscess
1%
Cytomegalovirus syndrome
1%
Cytomegalovirus viraemia
1%
Diabetic bullosis
1%
Diabetic foot
1%
Cerebral haemorrhage
1%
Hypercoagulation
1%
Thrombosis
1%
Adverse drug reaction
1%
Wound evisceration
1%
Renal artery dissection
1%
Urinary tract infection enterococcal
1%
Ventricular extrasystoles
1%
Obstructive uropathy
1%
Respiratory distress
1%
Progressive multifocal leukoencephalopathy
1%
Acute pulmonary oedema
1%
Renal artery thrombosis
1%
Acute myocardial infarction
1%
Atrial flutter
1%
Hypovolaemia
1%
Diverticular perforation
1%
Ureteral necrosis
1%
Ischaemic cardiomyopathy
1%
Toxicity to various agents
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Osteoarthritis
1%
Pleural effusion
1%
Cryptococcosis
1%
Renal haemorrhage
1%
Road traffic accident
1%
Vaginal haemorrhage
1%
Varicella
1%
Oral fungal infection
1%
Hyperparathyroidism tertiary
1%
Colon cancer metastatic
1%
Hepatic mass
1%
Phlebitis
1%
Small intestinal obstruction
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
29 Total Patients Enrolled
Virginia Kaklamani, MD, DScPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
~16 spots leftby Jul 2026
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