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New treatment option for ER-positive, HER2-negative Breast Cancer
Official title Capecitabine in ER+/HER2-negative Breast Cancer
ClinicalTrials.gov ID: NCT07631052
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for er-positive, her2-negative breast cancer.
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
- This is a Phase 2 study for patients with resected Stage I-III HR+/HER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo/adjuvant and locoregional therapy delivered with curative intent. In this study participants will be treated with capecitabine.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
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
- Male or female patients ≥ 18 years of age with histologically confirmed (by local assessment with ASCO/CAP criteria), resected...
- Evidence of MRD (positive test by the Pathlight assay) despite standard adjuvant therapy
- No contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic...
- No clinical or radiographic evidence of recurrent or metastatic disease
- Previous Therapy requirements: (i) Received at least 24 months of adjuvant endocrine therapy, including 6 months of an aromatase inhibitor and (i)...
You likely can't join if
- Prior therapy with capecitabine.
- Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin...
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or...
- Symptomatic chronic heart failure (e.g., New York Heart Association Class ≥ 2), history or current evidence of clinically significant cardiac...
- Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite...
See the full eligibility criteria
- Male or female patients ≥ 18 years of age with histologically confirmed (by local assessment with ASCO/CAP criteria), resected ER-positive/HER2-negative stage I-III breast cancer
- Evidence of MRD (positive test by the Pathlight assay) despite standard adjuvant therapy
- No contraindications to capecitabine (including absence of DPYD variants that in the opinion of the investigator are a contraindication to metronomic capecitabine)
- No clinical or radiographic evidence of recurrent or metastatic disease
- Previous Therapy requirements: (i) Received at least 24 months of adjuvant endocrine therapy, including 6 months of an aromatase inhibitor and (i) Received at least 12 months of adjuvant CDK4/6i if indicated, unless not...
- ECOG performance status of 0-1.
- Patient must have adequate organ function as determined by the following: a. Renal function:
- Serum creatinine \ 50mL/min using the Cockcroft-Gault formula b. Bone marrow function (without hematopoietic growth factors or transfusion):
- Absolute neutrophil count (ANC) \> 1.0 x 109/L
- Hemoglobin \> 90 g/L or \> 9g/dL
- Platelets \> 75 x 109/L c. Liver function:
- Total bilirubin ≤ 1.5 × ULN and \ 1.5 × ULN with indirect bilirubin \< 1.5 × ULN.
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \< 2.5 x ULN.
- Female participants of childbearing potential must have a negative serum β-HCG test result at enrolment.
- Female participants of childbearing potential must agree to use methods of contraception that are highly effective.
- Male participants must agree to use methods of contraception that are highly effective.
- The participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Signed written and voluntary informed consent.
- Prior therapy with capecitabine.
- Previous or concurrent malignancy within 3 years of study entry, with the following exceptions: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm...
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) \<6 months prior to screening,
- Symptomatic chronic heart failure (e.g., New York Heart Association Class ≥ 2), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality \<6 months prior to screening except...
- Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100mmHg, despite current therapy.
- Known positive serology for HIV (Human immunodeficiency virus) that is not currently controlled with antiretroviral therapy.
- Has a known history of or is positive for active hepatitis B or hepatitis C unless adequate viral suppression is achieved. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable...
- Impaired gastrointestinal function or disease that may significantly alter the absorption of capecitabine.
- Medical, psychiatric, cognitive, or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol, or complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Toronto, Ontario, Canada. 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.