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

Primary Purpose

Breast Cancer, Chemotherapy Effect

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Capecitabine

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, HR positive HER2 negative, high-risk factors, capecitabine, adjuvant chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

the Second Affiliated Hospital of Zhejiang Univercity School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

capecitabine group

Arm Description

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.

Outcomes

Primary Outcome Measures

disease free survival

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

defined as the time from randomizeation to all-cause death

invasive disease free survival

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

Full Information

NCT ID

NCT05212454

First Posted

January 15, 2022

Last Updated

April 22, 2023

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05212454

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2023 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Chemotherapy Effect

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

capecitabine group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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.

Primary Outcome Measure Information:

Title

disease free survival

Description

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 Outcome Measure Information:

Title

overall survival

Description

defined as the time from randomizeation to all-cause death

Time Frame

5 years

Title

invasive disease free survival

Description

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

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Tian, Doctor

Phone

+86 13777825246

denyiweit@zju.edu.cn

Facility Information:

Facility Name

the Second Affiliated Hospital of Zhejiang Univercity School of Medicine

City

Hanzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianan Wang, Doctor

First Name & Middle Initial & Last Name & Degree

Weilin Wang, Doctor

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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24872111

Citation

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Results Reference

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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.

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Citation

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

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