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New treatment option for Triple Negative Breast Cancer
Official title Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT04768426
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, being studied as a potential treatment for triple negative breast cancer.
Also referred to as fluoropyrimidine carbamate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Anatomic stage I - III triple-negative breast cancer at diagnosis
- Estrogen receptors (ER) and Progesterone receptors (PR) status \<10%
- Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted...
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
You likely can't join if
- Metastatic breast cancer
- Has not had definitive surgical resection
- Pregnant or breastfeeding
- Has not completed definitive adjuvant radiation if planned
- Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
- Investigational agents within 4 weeks of study initiation
See the full eligibility criteria
- Anatomic stage I - III triple-negative breast cancer at diagnosis
- Estrogen receptors (ER) and Progesterone receptors (PR) status \<10%
- Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted therapy during the neoadjuvant phase of treatment are eligible.
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- 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...
- No evidence of metastatic disease.
- A minimum 4-week wash out from previous chemotherapy treatment is required.
- Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
- Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT)...
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \> 50 mL/min using the Cockcroft Gault formula.
- Planned for 6 months or 8 cycles of adjuvant capecitabine.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
- Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.
- Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol
- Metastatic breast cancer
- Has not had definitive surgical resection
- Pregnant or breastfeeding
- Has not completed definitive adjuvant radiation if planned
- Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
- Investigational agents within 4 weeks of study initiation
- Inability to swallow oral medications
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.