Capecitabine for High-Risk HR+/HER2- Breast Cancer

Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks

Recruiting Phase 3 Interventional Study
Breast Cancer Chemotherapy 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 out Distant 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.

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Check Your Eligibility
About This Trial
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…
Trial Locations
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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…
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