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New treatment option for Breast Cancer
Official title Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer
ClinicalTrials.gov ID: NCT05063136
What this study is testing
What is Capecitabine+endocrine therapy?
Capecitabine+endocrine therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as Experimental group.
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
- Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Age: 18-70 years old
- Women with known menstrual status (at the beginning of randomization or adjuvant endocrine therapy). Postmenopausal status is defined as (1) The...
- Invasive breast cancer patients with HR (+) and HER2(-), which is confirmed by histopathology. (1) ER and/or PR positive (positive staining accounted...
- Patients received radical surgery and chemotherapy (neoadjuvant or adjuvant chemotherapy), and for patients who received neoadjuvant chemotherapy, at...
- Patients who have received breast cancer treatment in the past should meet the following conditions at the same time: (1) No more than 1 year after...
You likely can't join if
- Double primary cancers in active stage (simultaneous double primary cancers and heterochronous double primary cancers with disease-free interval ≤ 5...
- Bilateral breast cancer (simultaneous/metachronous) (Notes: patients with invasive breast cancer combined with contralateral DCIS, the patient was...
- Received oral 5-FU for more than 2 weeks before treatment (Notes: patient with a history of intravenous 5-FU was considered eligible for inclusion).
- Severe Diarrhea.
- Combined with the following serious complications: (1) Uncontrolled diabetes; (2) Uncontrolled hypertension; (3) Unstable angina and arrhythmias need...
- Past medical history: (1) myocardial infarction within 6 months; (2) Interstitial pneumonia (For local interstitial pneumonia, it can be proved to...
See the full eligibility criteria
- Age: 18-70 years old
- Women with known menstrual status (at the beginning of randomization or adjuvant endocrine therapy). Postmenopausal status is defined as (1) The patient has undergone bilateral ovariectomy, or (2) Age ≥ 60 years, or age...
- Invasive breast cancer patients with HR (+) and HER2(-), which is confirmed by histopathology. (1) ER and/or PR positive (positive staining accounted for more than 1% of all tumor cells) (2) HER-2 negative (IHC 0, 1+...
- Patients received radical surgery and chemotherapy (neoadjuvant or adjuvant chemotherapy), and for patients who received neoadjuvant chemotherapy, at least one of the following conditions should be met: (1) Patients not...
- Patients who have received breast cancer treatment in the past should meet the following conditions at the same time: (1) No more than 1 year after radical mastectomy. (2) For the patients receiving adjuvant...
- The following laboratory results should be met to determine that the patient has sufficient bone marrow and organ function: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet ≥ 100 × 109/L; hemoglobin ≥ 9.0 g / dl...
- For patients receiving anthracycline chemotherapy, EF value of cardiac ultrasound was ≥ 55% within 14 days before randomization;
- If the patient is a woman of childbearing age, the serum pregnancy test was negative within 14 days before randomization.
- ECOG score was 0 or 1.
- Patient has signed informed consent voluntarily.
- Double primary cancers in active stage (simultaneous double primary cancers and heterochronous double primary cancers with disease-free interval ≤ 5 years). Note: carcinoma in situ (intraepithelial carcinoma or lesion...
- Bilateral breast cancer (simultaneous/metachronous) (Notes: patients with invasive breast cancer combined with contralateral DCIS, the patient was considered eligible for inclusion if the contralateral DCIS have been...
- Received oral 5-FU for more than 2 weeks before treatment (Notes: patient with a history of intravenous 5-FU was considered eligible for inclusion).
- Severe Diarrhea.
- Combined with the following serious complications: (1) Uncontrolled diabetes; (2) Uncontrolled hypertension; (3) Unstable angina and arrhythmias need treatment; (4) cirrhosis and liver failure (5) Interstitial...
- Past medical history: (1) myocardial infarction within 6 months; (2) Interstitial pneumonia (For local interstitial pneumonia, it can be proved to improve after treatment. Not included in this definition). (3) History...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, 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 Zhengzhou, Henan, 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.