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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05212454
Other study ID # 2021-1116
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 15, 2023
Est. completion date December 2029

Study information

Verified date April 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wei Tian, Doctor
Phone +86 13777825246
Email denyiweit@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2029
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Capecitabine
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.

Locations

Country Name City State
China the Second Affiliated Hospital of Zhejiang Univercity School of Medicine Hanzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Walko CM, Lindley C. Capecitabine: a review. Clin Ther. 2005 Jan;27(1):23-44. doi: 10.1016/j.clinthera.2005.01.005. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary disease free survival defined as the time from randomization to recurrence in situ, metastasis, contralateral breast cancer, second primary cancer, and all-cause death. 5 years
Secondary overall survival defined as the time from randomizeation to all-cause death 5 years
Secondary invasive disease free survival Defined as time from randomization to local or distant recurrence of invasive cancer 5 years
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