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Anti-tumor antibiotic

Pegylated liposomal doxorubicin for Breast Cancer

Phase 2
Waitlist Available
Led By Pavani Chalisani, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a ECOG performance status of 0 - 2
Measurable disease by CT by RECIST 1.1 to evaluate response
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of treatment until the date of first documented progression or date of death, assessed up to an expected average of 100 weeks
Awards & highlights

Study Summary

This trial is looking at whether a certain protein has an effect on how well chemotherapy works in treating breast cancer.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment until the date of first documented progression or date of death, assessed up to an expected average of 100 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment until the date of first documented progression or date of death, assessed up to an expected average of 100 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate for Metastatic Breast Cancer Patients With Low BRCA1 Protein Expression in Their Tumor, Treated With Pegylated Liposomal Doxorubicin
Secondary outcome measures
Progression Free Survival for Patients With Breast Cancer With Low BRCA1 Protein Expression Treated With Pegylated Liposomal Doxorubicin

Side effects data

From 2020 Phase 3 trial • 366 Patients • NCT02631876
54%
Nausea
44%
Diarrhoea
43%
Vision blurred
34%
Fatigue
33%
Abdominal pain
32%
Keratopathy
28%
Dry eye
26%
Constipation
26%
Vomiting
25%
Decreased appetite
23%
Headache
21%
Visual acuity reduced
21%
Asthenia
20%
Neuropathy peripheral
18%
Aspartate aminotransferase increased
16%
Alanine aminotransferase increased
16%
Cough
16%
Hypomagnesaemia
15%
Cataract
15%
Dyspnoea
15%
Arthralgia
14%
Photophobia
14%
Anaemia
13%
Eye pain
12%
Urinary tract infection
12%
Dysgeusia
11%
Thrombocytopenia
11%
Abdominal distension
10%
Peripheral sensory neuropathy
10%
Muscle spasms
10%
Pyrexia
9%
Insomnia
9%
Back pain
9%
Myalgia
8%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Weight decreased
7%
Neutropenia
7%
Dizziness
7%
Hypokalaemia
7%
Dyspepsia
6%
Anxiety
6%
Paraesthesia
6%
Hypoalbuminaemia
6%
Abdominal pain upper
6%
Gastrooesophageal reflux disease
6%
Pain in extremity
5%
Nasopharyngitis
5%
Pruritus
5%
Dry mouth
5%
Pneumonitis
5%
Hyperglycaemia
5%
Vitreous floaters
5%
Muscular weakness
5%
Musculoskeletal pain
4%
Upper respiratory tract infection
4%
Nasal congestion
4%
Neurotoxicity
4%
Dehydration
4%
Intestinal obstruction
4%
Abdominal pain lower
4%
Stomatitis
4%
Ascites
4%
Visual impairment
4%
Leukopenia
4%
Rash
4%
Foreign body sensation in eyes
4%
Hyponatraemia
4%
Non-cardiac chest pain
3%
Tachycardia
3%
Flushing
3%
Epistaxis
3%
Cystitis
3%
Gamma-glutamyltransferase increased
3%
Abdominal discomfort
3%
Flatulence
3%
Keratitis
3%
Eye irritation
3%
Infusion related reaction
3%
Lymphopenia
3%
Alopecia
3%
Erythema
3%
Oedema peripheral
3%
Chills
3%
Haematuria
2%
Productive cough
2%
Micturition urgency
2%
Urinary incontinence
2%
Weight increased
2%
Hot flush
2%
Dysphonia
2%
Conjunctivitis
2%
Influenza
2%
Lacrimation increased
2%
Corneal deposits
2%
Hypoaesthesia
2%
Blood creatinine increased
2%
Depression
2%
Tinnitus
2%
Vaginal haemorrhage
2%
Sciatica
2%
Transaminases increased
2%
Intraocular pressure increased
2%
Pleural effusion
2%
Small intestinal obstruction
2%
Large intestinal obstruction
2%
Influenza like illness
2%
Malaise
2%
Pain
2%
Fall
2%
Respiratory tract infection
2%
Pharyngitis
2%
Dry skin
2%
Eye pruritus
2%
Ocular discomfort
2%
Punctate keratitis
2%
Hypophosphataemia
2%
Hyperuricaemia
2%
Hypocalcaemia
2%
Oropharyngeal pain
2%
Peripheral swelling
2%
Flank pain
2%
Pollakiuria
2%
Dysuria
1%
Haematoma
1%
Deep vein thrombosis
1%
Gingivitis
1%
Activated partial thromboplastin time prolonged
1%
Blood bilirubin increased
1%
Sinusitis
1%
Pneumonia
1%
Retching
1%
Gingival bleeding
1%
Odynophagia
1%
Cyst
1%
Cellulitis
1%
General physical health deterioration
1%
Mucosal inflammation
1%
Photopsia
1%
Uveitis
1%
Metamorphopsia
1%
Peripheral motor neuropathy
1%
Glaucoma
1%
Chalazion
1%
Conjunctival hyperaemia
1%
Presyncope
1%
Tremor
1%
Lacrimation decreased
1%
Xerophthalmia
1%
Arthritis
1%
Musculoskeletal stiffness
1%
Conjunctival haemorrhage
1%
Cardiac arrest
1%
Disturbance in attention
1%
Lethargy
1%
Groin pain
1%
Depressed mood
1%
Urinary retention
1%
Dyspareunia
1%
Pelvic pain
1%
Laceration
1%
Bone pain
1%
Ligament sprain
1%
Pulmonary embolism
1%
Agitation
1%
Proteinuria
1%
Ear pain
1%
Sepsis
1%
Syncope
1%
Balance disorder
1%
Neuralgia
1%
Dyspnoea exertional
1%
Lung disorder
1%
Palpitations
1%
Hyperhidrosis
1%
Sinus tachycardia
1%
Pleuritic pain
1%
Rhinorrhoea
1%
Hepatic enzyme increased
1%
Urine leukocyte esterase positive
1%
Contusion
1%
Urinary tract obstruction
1%
Vertigo
1%
Ocular hyperaemia
1%
Chest discomfort
1%
Adverse drug reaction
1%
Chest pain
1%
Herpes zoster
1%
Oral herpes
1%
Viral upper respiratory tract infection
1%
Hepatotoxicity
1%
Hyperbilirubinaemia
1%
Gastroenteritis
1%
Ear infection
1%
Leukocytosis
1%
Injection site bruising
1%
Blepharitis
1%
Diplopia
1%
Asthenopia
1%
Mobility decreased
1%
Musculoskeletal chest pain
1%
Neck pain
1%
Hypercalcaemia
1%
Sinus congestion
1%
Photosensitivity reaction
1%
Night sweats
1%
Petechiae
1%
Rash maculo-papular
1%
Embolism
1%
Vulvovaginal pain
1%
Vulvovaginal pruritus
1%
Aphthous ulcer
1%
Rectal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mirvetuximab Soravtansine
Investigator's Choice (IC) Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pegylated liposomal doxorubicinExperimental Treatment1 Intervention
The enrolled patients will be treated with pegylated liposomal doxorubicin at 30mg/m2 every 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegylated liposomal doxorubicin
2005
Completed Phase 4
~2260

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
512 Previous Clinical Trials
147,777 Total Patients Enrolled
22 Trials studying Breast Cancer
2,540 Patients Enrolled for Breast Cancer
Pavani Chalisani, MDPrincipal InvestigatorUniversity of Arizona

Frequently Asked Questions

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

What is the margin of safety for Pegylated liposomal doxorubicin?

"Pegylated liposomal doxorubicin is in Phase 2 of clinical trials, which means that while there is some safety data, none exists to support efficacy. Our team rates it as a 2 on our 1-3 scale."

Answered by AI

What types of cancers does Pegylated liposomal doxorubicin show efficacy against?

"Pegylated liposomal doxorubicin is an effective treatment method for various types of cancer, including lymphoma, hodgkins, carcinoma, bronchogenic, and neuroblastoma (nb)."

Answered by AI

To your knowledge, are there other clinical trials like this one?

"As of right now, there are 381 active trials for Pegylated liposomal doxorubicin in 67 countries and 1935 cities. The first ever trial involving this medication was sponsored by Alfacell Corporation and completed back in 1997. That initial study had 300 participants and successfully made it to Phase 3 approval. In the 23 years since that landmark clinical trial, 678 more have been conducted."

Answered by AI

Are there any other similar clinical trials that have used Pegylated liposomal doxorubicin?

"Pegylated liposomal doxorubicin was first studied in 1997. So far, there have been a total of 678 completed studies. As of now, 381 clinical trials are still recruiting patients. Many of these studies are based in Tucson, Arizona."

Answered by AI

How many participants are needed for this research project?

"Patients are not being actively recruited for this trial at the moment. This study was first posted on November 5th, 2013 and was last edited on June 1st, 2022. However, there are currently 2698 trials related to breast cancer and 381 trials concerning Pegylated liposomal doxorubicin that are recruiting patients."

Answered by AI

Are there any patients still needed for this research project?

"The clinical trial in question is no longer recruiting patients, as evidenced by the fact that it was last updated on 6/1/2022. This particular study was posted on 11/5/2013. There are currently 3079 other trials enrolling patients."

Answered by AI
~2 spots leftby Mar 2025