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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05212454

Collaborator

(none)

400

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Chemotherapy Effect	Drug: Capecitabine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

disease free survival [5 years]
defined as the time from randomization to recurrence in situ, metastasis, contralateral breast cancer, second primary cancer, and all-cause death.

Secondary Outcome Measures

overall survival [5 years]
defined as the time from randomizeation to all-cause death
invasive disease free survival [5 years]
Defined as time from randomization to local or distant recurrence of invasive cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Wei Tian, Vice Director of Department of Breast Surgery and Oncology, Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05212454

Other Study ID Numbers:

2021-1116

First Posted:

Jan 28, 2022

Last Update Posted:

Mar 14, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wei Tian, Vice Director of Department of Breast Surgery and Oncology, Second Affiliated Hospital, School of Medicine, Zhejiang University

breast cancer

HR positive HER2 negative

high-risk factors

capecitabine

adjuvant chemotherapy

Additional relevant MeSH terms:

Breast Neoplasms

Capecitabine

Study Results

No Results Posted as of Mar 14, 2022