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Capecitabine for Triple-Negative Breast Cancer

Phase 2
Recruiting
Led By Melinda Telli
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
No evidence of metastatic disease.
Must not have
Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
Has not completed definitive adjuvant radiation if planned
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial uses a blood test to find cancer DNA in patients with a tough type of breast cancer. It helps doctors see if the current treatment is working or if a different one is needed.

Who is the study for?
This trial is for adults over 18 with early-stage triple-negative breast cancer who've had some chemo but still have disease present. They must be planning to take capecitabine, have good kidney and liver function, not be pregnant or breastfeeding, and agree to use contraception. People with metastatic cancer, HIV, hepatitis B/C, or recent investigational drug use can't join.
What is being tested?
The study tests if monitoring ctDNA levels in the blood can predict the effectiveness of capecitabine treatment in preventing breast cancer relapse. It involves regular 'liquid biopsies' during treatment to see how ctDNA changes correlate with tumor genetics.
What are the potential side effects?
Capecitabine may cause side effects like diarrhea, hand-foot syndrome (redness and pain on palms/soles), nausea, fatigue, mouth sores, low blood cell counts increasing infection risk; heart problems are less common but serious.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My side effects from previous cancer treatments are mild, except for hair loss and some nerve pain.
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My cancer has not spread to other parts of my body.
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My blood tests show normal white blood cell and platelet counts.
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My breast cancer was stage I-III and triple-negative at diagnosis.
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I am 18 years old or older.
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I am scheduled for 6 months or 8 cycles of capecitabine treatment.
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My kidney function is within the normal range.
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My cancer is mostly not driven by estrogen or progesterone.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive or have active hepatitis B or C.
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I have not finished my planned radiation therapy.
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I have not had surgery to completely remove my cancer.
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I cannot swallow pills.
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My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline levels of ctDNA detection
Secondary study objectives
Correlation of ctDNA levels with genomic features of tumor
Overall Survival (OS)
Relapse-Free Survival

Side effects data

From 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870
63%
Nausea
58%
Fatigue
54%
Diarrhoea
50%
Decreased Appetite
46%
Vomiting
42%
Hypokalaemia
42%
Pyrexia
38%
Abdominal Pain
33%
Constipation
33%
Blood Bilirubin Increased
29%
Abdominal Distension
29%
Hyponatraemia
29%
Dizziness
29%
Oedema Peripheral
29%
Back Pain
25%
Hypotension
25%
Stomatitis
25%
Palmar-plantar Erythrodysaethesia Syndrome
25%
Dehydration
25%
Anaemia
21%
Chills
21%
Aspartate Aminotransferase Increased
21%
Dyspnoea
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Hyperbilirubinaemia
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Cough
13%
Hypomagnesaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Musculoskeletal pain
8%
Blood alkaline phosphatase increased
8%
Bursitis
8%
Gastrooesophageal Reflux Disease
8%
Malaise
8%
Faeces discolored
8%
Influenza like illness
8%
International normalised ratio increased
8%
Hypoaesthesia
8%
Paraesthesia
8%
Depression
8%
Gamma-glutamyltransferase increased
8%
Dysphonia
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
4%
Hyponatremia
4%
Cardiac arrest
4%
Rash generalized
4%
Respiratory Failure
4%
Septic shock
4%
Small intestinal obstruction
4%
Spinal cord compression
4%
Toxic leukoencephalopathy
4%
Peripheral Sensory Neuropathy
4%
Haematemesis
4%
Hypercalcaemia
4%
Hypoxic-ischaemic encephalopathy
4%
Ischaemic stroke
4%
Lung Infection
4%
Metabolic acidosis
4%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo and Capecitabine - Part 1
Varlitinib and Capecitabine - Safety Lead-In
Varlitinib and Capecitabine - Part 1

Trial Design

1Treatment groups
Experimental Treatment
Group I: CapecitabineExperimental Treatment1 Intervention
1000 mg/m2 administered on Days 1 to 14 of 21-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3970

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, but it can also affect normal cells, leading to side effects. Targeted therapies, such as HER2 inhibitors, specifically target cancer cells with certain genetic markers, reducing damage to normal cells and improving treatment efficacy. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Monitoring treatment efficacy using ctDNA assays is crucial as it allows for real-time assessment of how well these treatments are working, enabling personalized adjustments to therapy and potentially improving outcomes for breast cancer patients.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,369 Total Patients Enrolled
60 Trials studying Breast Cancer
111,024 Patients Enrolled for Breast Cancer
Melinda TelliPrincipal InvestigatorStanford Universiy
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer

Media Library

Capecitabine Clinical Trial Eligibility Overview. Trial Name: NCT04768426 — Phase 2
~7 spots leftby Feb 2026
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