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

Breast Cancer Clinical Trial

Official title:

Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients: a Multicenter, Single-arm Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05212454
• Other study ID #: 2021-1116
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect

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)

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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

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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