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Anti-metabolites
Low Dose Capecitabine for Breast Cancer
Phase 2
Waitlist Available
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
Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.
Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial tests capecitabine as a treatment for breast cancer in elderly/frail patients with higher risk of complications.
Who is the study for?
This trial is for patients aged ≥60 or frail at any age with advanced breast cancer who have progressed after one treatment line. They must have adequate organ function, HER2 negative status, and either hormone receptor positive or triple-negative breast cancer. Exclusions include HER2 positive cancer, untreated spinal cord compression, prior capecitabine use in metastatic setting, non-measurable disease only, severe liver/renal failure, inability to swallow pills or recent major surgery.Check my eligibility
What is being tested?
The study tests a low dose of the Capecitabine pill (1000 mg daily) on older or frail patients with advanced breast cancer to see if it's effective and safer than other treatments. It's a phase II single-arm trial where all participants receive the same intervention without comparison groups.See study design
What are the potential side effects?
Capecitabine can cause side effects like diarrhea, hand-foot syndrome (redness/pain/swelling of hands/feet), nausea/vomiting, fatigue and may affect blood counts leading to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is either hormone receptor positive or triple negative.
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My breast cancer has spread and has at least one tumor that can be measured.
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My kidneys are functioning well enough to clear creatinine.
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My cancer has worsened after at least one treatment in its advanced stage.
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My breast cancer is confirmed HER2 negative by a lab test.
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I can take care of myself and am up and about more than half of the day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (RR) evaluation
Secondary outcome measures
Number of adverse events
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2019 Phase 2 trial • 10 Patients • NCT0200088260%
Nausea
50%
Vomiting
50%
Fatigue
50%
Anorexia
50%
Hypokalemia
40%
Urinary tract infection
40%
Diarrhea
40%
Mucositis oral
30%
Insomnia
30%
Palmar-plantar erythrodysesthesia
30%
Rash
20%
AST increased
20%
Seizure
20%
Blurred vision
20%
Falling down
20%
Bilirubin increased
20%
ALT increased
20%
Dehyrdration
20%
Constipation
20%
Hyponatremia
20%
Headache
10%
Hypertension
10%
Facial swelling
10%
Disorder ear
10%
Epilepsy
10%
Knee Pain
10%
Rash erythematous
10%
Anemia
10%
Hypovolemia
10%
Leukopenia
10%
Neutropenia
10%
Disorder eye
10%
Eye floaters
10%
Vision abnormal
10%
Stomatitis
10%
Hand-foot syndrome
10%
Legs restless
10%
Taste alteration
10%
Allergic reaction
10%
Thrush
10%
Creatinine serum increased
10%
Amylase increased
10%
Growth accelerated
10%
Hyperglycemia
10%
Dyspnea
10%
Epistaxis
10%
Colitis
10%
Dysphagia
10%
Weakness generalized
10%
Visual disturbance
10%
Abdominal Pain
10%
Canker sore oral
10%
Cramp abdominal
10%
Dry mouth
10%
Gastritis
10%
Hemorrhoids
10%
Pancreatitis
10%
Spasm oropharyngeal
10%
Hypocalcemia
10%
Lipase increased
10%
Dizziness
10%
Edema cerebral
10%
Neuropathy
10%
Numbness
10%
Somnolence
10%
Tremor
10%
Agitation
10%
Depression
10%
Emotional lability
10%
Incontinence urinary
10%
Renal function abnormal
10%
Potassium deficiency
10%
Muscle weakness
10%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
BKM120 Plus Capecitabine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Low dose capecitabine (Xeloda)Experimental Treatment1 Intervention
1000 mg capecitabine daily by mouth.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine Pill
2018
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,004 Total Patients Enrolled
32 Trials studying Breast Cancer
4,491 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How would you assess the security of administering Low dose capecitabine (Xeloda) to individuals?
"Our team at Power determined the safety of Low dose capecitabine (Xeloda) to be a 2, since there is only limited data supporting its security and none concerning efficacy."
Answered by AI
Are there any open slots to join this experiment?
"Clinicaltrials.gov indicates that this medical trial, which began on April 1st 2024 and was last changed on October 23rd 2023, is no longer enrolling patients at the present moment. However, there are 2439 other studies actively seeking participants currently."
Answered by AI
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