What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy agents like capecitabine, endocrine therapies, and targeted therapies, are associated with a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infections. Capecitabine specifically may lead to hand-foot syndrome, diarrhea, and mucositis. Endocrine therapies, such as tamoxifen, can result in hot flashes, vaginal dryness, and an increased risk of blood clots. Aromatase inhibitors may cause joint pain, bone density loss, and cardiovascular issues. Targeted therapies, like anti-HER2 agents, can lead to cardiac dysfunction and infusion-related reactions. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including targeted therapies, hormone therapies, and chemotherapies. Notable targeted therapies include trastuzumab (Herceptin) for HER2-positive breast cancer and palbociclib (Ibrance) for HR-positive, HER2-negative breast cancer. Hormone therapies like tamoxifen and aromatase inhibitors are also widely used. The ctDNA assay, or liquid biopsy, is a promising tool for monitoring treatment efficacy, particularly in identifying genetic mutations and tracking tumor dynamics in real-time, which can help tailor personalized treatment plans.

What other types of research exist?

Promising alternatives to ctDNA assays for monitoring treatment efficacy in breast cancer patients include blood-based microRNAs, circulating tumor cells (CTCs), and methylation signatures in cell-free DNA. These methods have demonstrated potential in clinical studies for cancer detection and monitoring.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Pain

Dysgeusia

Respiratory infection

Abdominal pain

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Dislocation of hip

Bronchial infection

Urinary tract infection

Thromboembolic event

Osteonecrosis of jaw

Palmar-plantar erythrodysesthesia syndrome

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4280

0 / 14Eligibility criteria met

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.