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RecruitingNCT05212454Updated Apr 25, 2023

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

A Phase 3 interventional study of Capecitabine in Breast Cancer and Chemotherapy Effect, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breast Cancer
  • Chemotherapy Effect

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Keywords

  • breast cancer
  • HR positive HER2 negative
  • high-risk factors
  • capecitabine
  • adjuvant chemotherapy
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 400 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    capecitabine group

    All enrolled cases should be given standard chemotherapy, radiotherapy and endocrine therapy according to the Chinese Society of Clinical Oncology (CSCO) guidelines for the treatment of breast cancer, with the specific regimen decided by the doctor according to the condition. After the completion of standard chemotherapy, capecitabine 1250mg/m2 should be given orally twice a day for 2 weeks of the 3-week treatment course, and the total duration of treatment is 8 courses, which can be given simultaneously with radiotherapy and endocrine therapy. Premenopausal patients may use ovarian suppressants as needed.

    Drug: Capecitabine

Interventions

  • DrugCapecitabine

    capecitabine, 0.5g per pill, given 1250mg/m2 twice a day for 2 weeks of the 3-week treatment course. The total duration of treatment is 8 courses.

06

What researchers measure

Primary outcomes

  1. disease free survival

    defined as the time from randomization to recurrence in situ, metastasis, contralateral breast cancer, second primary cancer, and all-cause death.

    Time frame: 5 years

Secondary outcomes

  1. overall survival

    defined as the time from randomizeation to all-cause death

    Time frame: 5 years

  2. invasive disease free survival

    Defined as time from randomization to local or distant recurrence of invasive cancer

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • the Second Affiliated Hospital of Zhejiang Univercity School of Medicine
    Hanzhou, Zhejiang, China
    • Jianan Wang, Doctor · Contact
    • Weilin Wang, Doctor · Contact
    Recruiting
08

References and documents

Publications

  • Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9. PubMed 24872111 ↗
  • Yin W, Di G, Zhou L, Lu J, Liu G, Wu J, Shen K, Han Q, Shen Z, Shao Z. Time-varying pattern of recurrence risk for Chinese breast cancer patients. Breast Cancer Res Treat. 2009 Apr;114(3):527-35. doi: 10.1007/s10549-008-0022-5. Epub 2008 Apr 19. PubMed 18425576 ↗
  • Mamounas EP, Tang G, Paik S, Baehner FL, Liu Q, Jeong JH, Kim SR, Butler SM, Jamshidian F, Cherbavaz DB, Sing AP, Shak S, Julian TB, Lembersky BC, Lawrence Wickerham D, Costantino JP, Wolmark N. 21-Gene Recurrence Score for prognosis and prediction of taxane benefit after adjuvant chemotherapy plus endocrine therapy: results from NSABP B-28/NRG Oncology. Breast Cancer Res Treat. 2018 Feb;168(1):69-77. doi: 10.1007/s10549-017-4550-8. Epub 2017 Nov 11. PubMed 29128898 ↗
  • Natori A, Ethier JL, Amir E, Cescon DW. Capecitabine in early breast cancer: A meta-analysis of randomised controlled trials. Eur J Cancer. 2017 May;77:40-47. doi: 10.1016/j.ejca.2017.02.024. Epub 2017 Mar 27. PubMed 28355581 ↗
  • Walko CM, Lindley C. Capecitabine: a review. Clin Ther. 2005 Jan;27(1):23-44. doi: 10.1016/j.clinthera.2005.01.005. PubMed 15763604 ↗
  • Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645. PubMed 28564564 ↗
  • Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Kokko R, Ahlgren J, Auvinen P, Paija O, Helle L, Villman K, Nyandoto P, Nilsson G, Pajunen M, Asola R, Poikonen P, Leinonen M, Kataja V, Bono P, Lindman H. Adjuvant capecitabine, docetaxel, cyclophosphamide, and epirubicin for early breast cancer: final analysis of the randomized FinXX trial. J Clin Oncol. 2012 Jan 1;30(1):11-8. doi: 10.1200/JCO.2011.35.4639. Epub 2011 Nov 21. PubMed 22105826 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05212454
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Responsible party
Wei Tian (Vice Director of Department of Breast Surgery and Oncology, Second Affiliated Hospital, Zhejiang University, School of Medicine) — Principal investigator
First posted
Jan 28, 2022
Start date
Mar 15, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2029 (estimated)
Last update
Apr 25, 2023

Study contacts

Wei Tian, Doctor
Contact
denyiweit@zju.edu.cn
+86 13777825246

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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