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Tests treatment safety and results for Breast Cancer
Official title Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
ClinicalTrials.gov ID: NCT05212454
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for 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
- According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases. Among Chinese breast cancer patients, approximately 60% are hormone receptor (HR) positive, and 80% have early-stage breast cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Female, age 18-70 years.
- Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as...
- Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic...
- No prior treatment for present breast cancer onset.
- ECOG physical status score 0 to 1
You likely can't join if
- Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
- Women during pregnancy and breastfeeding after pregnancy.
- Women with proven distant metastases of breast cancer.
- Patients with proven sensory or motor nerve disease.
- Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.
- Patients who need long-term anticoagulant drugs for cardiovascular or thrombotic diseases.
See the full eligibility criteria
- Female, age 18-70 years.
- Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells \>1%) and HER2 negative (defined as HER2...
- Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic grade 3 or ki67 ≥ 20%; or residual lesions despite neoadjuvant...
- No prior treatment for present breast cancer onset.
- ECOG physical status score 0 to 1
- Hematological examination before treatment should meet: white blood cell count (WBC) ≥ 4.0×10\^9/L, neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count (PLT) ≥ 100×10\^9/L; hemoglobin (Hb) ≥ 90g/L; AST (sGOT), ALT...
- No serious impairment of heart, liver, kidney and other important organ functions.
- Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
- Women during pregnancy and breastfeeding after pregnancy.
- Women with proven distant metastases of breast cancer.
- Patients with proven sensory or motor nerve disease.
- Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.
- Patients who need long-term anticoagulant drugs for cardiovascular or thrombotic diseases.
- History of other tumors.
- Allergic to the study drug or its excipients, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, Zhejiang, China
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 female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanzhou, Zhejiang, China. 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.