Capecitabine for High-Risk HR+/HER2- Breast Cancer
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
Recruiting
Phase 3Interventional Study
Breast CancerChemotherapy Effect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
Who this trial is looking for
This trial is looking for women aged 18 to 70 who have had surgery for HR-positive HER2-negative breast cancer. Participants will receive an additional treatment of capecitabine to see if it helps prevent the cancer from coming back.
Are You a Good Fit for This Trial?
Rules you outDistant breast cancerHeart diseaseNerve disease
You may be able to join if
I am a woman aged 18 to 70 years.
I have had surgery for breast cancer.
I have hormone receptor positive and HER2 negative breast cancer.
I have high-risk factors for recurrence of breast cancer.
I have not had any treatment for my current breast cancer.
My physical status score is 0 or 1.
My blood tests meet the required levels.
I have normal function in my important organs.
You may not be able to join if
I am pregnant or breastfeeding.
I have distant spread of breast cancer.
I have nerve disease.
I have severe heart disease or active infection.
I need long-term anticoagulant drugs.
I have a history of other tumors.
I am allergic to the study drug.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. For HR-positive, human epidermal growth factor receptor-2 (HER2…
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. For HR-positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer patients, the first peak of recurrence is about 2-3 years after surgery, especially for patients with high-risk clinical and/or pathological features. Therefore, adjuvant therapy is essential to reduce recurrence during this period.
Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil (5-Fu) in vivo. Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer. Therefore, we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors.
This trial is an open, single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors.
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Eligibility Criteria
Inclusion 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 immunohistochemistry 2+ or less and FISH nega…
Inclusion 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 immunohistochemistry 2+ or less and FISH negative).
* 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 chemotherapy.
* 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 (sGPT) ≤ 1.5 times the normal value upper limit, creatinine ≤ 1.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value.
* No serious impairment of heart, liver, kidney and other important organ functions.
Exclusion Criteria:
* 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.
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