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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether a liquid biopsy can help identify which triple-negative breast cancer patients will benefit from capecitabine treatment.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline levels of ctDNA detection
Secondary outcome measures
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%
Pyrexia
42%
Hypokalaemia
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%
Aspartate Aminotransferase Increased
21%
Dyspnoea
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Hyperbilirubinaemia
13%
Cough
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Hypomagnesaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Depression
8%
Gastrooesophageal Reflux Disease
8%
Gamma-glutamyltransferase increased
8%
International normalised ratio increased
8%
Paraesthesia
8%
Influenza like illness
8%
Dysphonia
8%
Malaise
8%
Hypoaesthesia
8%
Faeces discolored
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Bursitis
8%
Musculoskeletal pain
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
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%
Hyponatremia
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
~3420

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,570 Total Patients Enrolled
60 Trials studying Breast Cancer
111,155 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

Frequently Asked Questions

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

To what maladies is Capecitabine typically administered?

"Capecitabine is regularly employed to combat malignant neoplasms. It has been found useful against pancreatic endocrine carcinoma, colorectal carcinoma, and refractory ovarian cancer as well."

Answered by AI

Has the Federal Drug Administration granted its stamp of approval to Capecitabine?

"Our team at Power has ascribed a score of 2 to Capecitabine as this Phase 2 trial only displays data validating the therapy's safety but not its efficacy."

Answered by AI

Can you provide an overview of the research conducted using Capecitabine?

"At present, there are 334 ongoing studies of Capecitabine with 126 trials in Phase 3. Of those investigations, the majority take place near Woolloongabba, Queensland; however, research sites for this drug can be found across 12828 locations worldwide."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"The trial is currently recruiting participants, as evidenced by the clinicaltrials.gov listing. It was first made available on February 3rd 2021 and was most recently amended on January 7th 2022."

Answered by AI

What is the cap on participation in this research endeavor?

"Affirmative. Clinicaltrial.gov verifies that this clinical trial, first unveiled on February 3rd 2021, is still actively recruiting participants. As part of the study, 25 test subjects need to be sourced from a single medical facility."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
2021. "Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04768426.
~9 spots leftby Feb 2026
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