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Alkylating agents
Cyclophosphamide + Veliparib for Advanced Breast Cancer
Phase 1
Waitlist Available
Led By Joseph A Sparano
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HER2/neu negative disease (performed on primary tumor and/or metastatic lesion using commercially available/approved assay in local institutional or reference laboratory), according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Disease that is metastatic (stage IV [TxNxM1]) or locally advanced and not amenable to potentially curative surgical resection (eg, clinical stage IIIB-C)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs, cyclophosphamide and veliparib, when given together to treat patients with breast cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults with advanced or metastatic HER2/neu negative breast cancer who've had prior chemotherapy. They must have a certain level of blood cells, no severe liver/kidney issues, and be able to take oral meds. Pregnant women, those unable to use contraception, or patients with recent seizures or bowel obstructions can't join.Check my eligibility
What is being tested?
The study tests the combination of Cyclophosphamide (a chemo drug) and Veliparib (which blocks enzymes helping tumor growth) in treating advanced breast cancer. It aims to find the safest doses and observe side effects when these drugs are given together.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, hair loss from cyclophosphamide; fatigue, low blood cell counts affecting immunity may occur too. Veliparib might cause digestive issues and affect bone marrow function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is not HER2 positive, as tested on my primary or metastatic tumor.
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My cancer has spread to other parts of my body or is advanced and cannot be removed by surgery.
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I can take care of myself but may not be able to do heavy physical work.
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I can swallow pills without any trouble.
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My hemoglobin level is 9 g/dl or higher.
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My breast cancer is confirmed and does not have the HER2 protein.
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My kidney function, measured by creatinine levels, is normal or nearly normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose of veliparib and cyclophosphamide
Secondary outcome measures
Clinical response (complete or partial response) according to RECIST version 1.1
MacroH2A1.1 expression levels
Overall survival
+1 moreSide effects data
From 2024 Phase 3 trial • 509 Patients • NCT0216369487%
NEUTROPENIA
76%
THROMBOCYTOPENIA
76%
ANAEMIA
71%
NAUSEA
54%
ALOPECIA
50%
FATIGUE
46%
PERIPHERAL SENSORY NEUROPATHY
45%
DIARRHOEA
40%
LEUKOPENIA
36%
HEADACHE
34%
CONSTIPATION
34%
VOMITING
25%
ASTHENIA
24%
DECREASED APPETITE
24%
HYPOMAGNESAEMIA
21%
COUGH
20%
DYSPNOEA
20%
PAIN IN EXTREMITY
20%
DYSGEUSIA
19%
DIZZINESS
19%
OEDEMA PERIPHERAL
18%
BACK PAIN
18%
DYSPEPSIA
18%
INSOMNIA
18%
ARTHRALGIA
18%
EPISTAXIS
17%
MYALGIA
17%
DRUG HYPERSENSITIVITY
16%
ABDOMINAL PAIN UPPER
16%
PYREXIA
16%
NASOPHARYNGITIS
16%
ALANINE AMINOTRANSFERASE INCREASED
14%
ABDOMINAL PAIN
14%
UPPER RESPIRATORY TRACT INFECTION
14%
ASPARTATE AMINOTRANSFERASE INCREASED
13%
LYMPHOPENIA
13%
STOMATITIS
12%
HYPOKALAEMIA
12%
URINARY TRACT INFECTION
12%
BONE PAIN
11%
ANXIETY
11%
RASH
11%
HOT FLUSH
10%
DRY MOUTH
9%
PRURITUS
9%
HYPOCALCAEMIA
9%
PARAESTHESIA
9%
DEPRESSION
9%
MUCOSAL INFLAMMATION
8%
HYPOPHOSPHATAEMIA
8%
OROPHARYNGEAL PAIN
7%
MUSCULOSKELETAL CHEST PAIN
7%
DRY SKIN
7%
INFLUENZA LIKE ILLNESS
7%
VERTIGO
7%
SINUSITIS
7%
MUSCULOSKELETAL PAIN
7%
DRY EYE
7%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
LYMPHOEDEMA
6%
RHINORRHOEA
6%
PALPITATIONS
6%
DYSPNOEA EXERTIONAL
6%
TINNITUS
6%
WEIGHT INCREASED
6%
HYPERTENSION
6%
HYPERGLYCAEMIA
6%
NEUROPATHY PERIPHERAL
6%
TOOTHACHE
6%
PAIN
5%
CHEST PAIN
5%
DEHYDRATION
5%
GASTROOESOPHAGEAL REFLUX DISEASE
5%
BREAST PAIN
5%
HYPONATRAEMIA
5%
PRODUCTIVE COUGH
5%
ERYTHEMA
5%
MUSCLE SPASMS
5%
ABDOMINAL DISTENSION
5%
INFLUENZA
5%
RHINITIS
4%
MALIGNANT NEOPLASM PROGRESSION
4%
TACHYCARDIA
4%
RESPIRATORY TRACT INFECTION VIRAL
3%
FEBRILE NEUTROPENIA
2%
PNEUMONIA
1%
SEPSIS
1%
NEUTROPENIC INFECTION
1%
GASTRITIS
1%
SEIZURE
1%
ANAPHYLACTIC REACTION
1%
APPENDICITIS
1%
PULMONARY EMBOLISM
1%
CHOLELITHIASIS
1%
CELLULITIS
1%
DEVICE RELATED INFECTION
1%
ERYSIPELAS
1%
VASCULAR DEVICE INFECTION
1%
METASTASES TO MENINGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Veliparib Placebo With Carboplatin and Paclitaxel
Veliparib With Carboplatin and Paclitaxel
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (veliparib, cyclophosphamide)Experimental Treatment3 Interventions
Patients receive veliparib orally PO QD and cyclophosphamide PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Veliparib
2012
Completed Phase 3
~4820
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,118 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Joseph A SparanoPrincipal InvestigatorMontefiore Medical Center - Moses Campus
1 Previous Clinical Trials
10,273 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is not HER2 positive, as tested on my primary or metastatic tumor.I have previously been treated with PARP inhibitors like veliparib or olaparib.Your platelet count is at least 100,000 per microliter.I haven't had radiotherapy in the last 3 weeks or recovered from previous treatment side effects.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am not pregnant or breastfeeding and willing to use two forms of birth control.I've had chemotherapy for my cancer, or I have a BRCA1 or BRCA2 mutation.I do not have active brain metastases requiring medication.My cancer has spread to other parts of my body or is advanced and cannot be removed by surgery.My cancer progressed after endocrine therapy for metastatic disease.I am using or will use birth control during the study, or I cannot become pregnant.I can take care of myself but may not be able to do heavy physical work.I had brain cancer spread, treated with radiation, stable for 3+ months, and I'm not on steroids.I cannot take pills due to a blockage or problem in my intestines.I have had a seizure in the last 6 months and take medication for it.My cancer's size or presence can be measured by recent tests.I can swallow pills without any trouble.Your white blood cell count is at least 3,000 per microliter.I cannot swallow whole capsules.My hemoglobin level is 9 g/dl or higher.Your total bilirubin levels are within normal range, unless it's only a little high due to Gilbert's disease.I do not have conditions affecting my body's ability to absorb nutrients.Your absolute neutrophil count is at least 1,500 per microliter of blood.My breast cancer is confirmed and does not have the HER2 protein.I do not have HIV, hepatitis B or C, or any severe infection or illness.Your AST and ALT levels in your blood should not be more than 2.5 times the normal limit set by the hospital.I have no allergies to veliparib or cyclophosphamide.My kidney function, measured by creatinine levels, is normal or nearly normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (veliparib, cyclophosphamide)
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.
What is the sample size of this clinical trial?
"Currently, this research project is not recruiting studies. It was initially posted on May 2nd 2011 and last updated on July 19th 2022. If you seek out other trials related to breast cancer, there are presently 4566 clinical trial options available; similarly 836 trials are accepting patients for Veliparib intervention."
Answered by AI
In what medical contexts is Veliparib typically administered?
"Veliparib is widely prescribed to patients suffering from multiple sclerosis, while it can also be a viable treatment option for lymphoma of varying origins, acute and myelocytic leukemia, and retinoblastoma."
Answered by AI
Has Veliparib acquired the stamp of approval from the FDA?
"There is limited evidence to support the safety of veliparib, thus it earned a rating of 1 on our team's scale."
Answered by AI
Does this research protocol currently have open enrollment?
"Unfortunately, this medical study is not presently accepting candidates as indicated on clinicaltrials.gov where the trial was first posted in May 2011 and last updated 19th July 2022. However, there are other 5402 trials currently recruiting participants."
Answered by AI
Has Veliparib previously been a part of any other medical investigations?
"Currently, 836 active investigations into veliparib are being conducted with 156 of these in the third phase. Of those trials based out of Philadelphia, Pennsylvania, there are 31270 sites engaged in research regarding this medication."
Answered by AI
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