Capecitabine in HER-2 Positive Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy

HER2-positive Breast Cancer Clinical Trial

Official title:

Randomised, Multicenter Phase II Study in Patients With HER-2 Positive Breast Cancer With Capecitabine Versus Observation With Pathologic Residual Tumors After Preoperative Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03684863
• Other study ID #: ShandongCHI-06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2018
• Est. completion date: December 2025

Study information

• Verified date: September 2018
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong Yu, PhD
• Phone: 86053167626234
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the efficacy and safety of capecitabine, as a postoperative adjuvant chemotherapy, for HER-2 positive breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis.

2. Stage I-IIIB at the first diagnosis and underwent curative resection.

3. The patient was non-pCR after preoperative chemotherapy including anthracycline agents; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells. The previously adminstered preoperative chemotherapy must have involved at least four cycles of anthracycline agents. However, even if anthracycline regimen is shorter than 4 courses, the following regimen can be registered.

• FEC 3 courses (EPI>=100mg/m2)+Docetaxel 3 courses and trastuzumab 3 courses.

• TCH only over 6 courses

4. The patient has been confirmed to be HER2 positive. etc.

5. The patient's general performance status is 0 to 1.

6. The patient must have no carry-over of efficacy from any previous treatment.

7. The patient has maintained sufficient organ function to permit valid evaluation.

8. The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment.

9. The patient's creatinine clearance is higher than 50 ml/min

10. The patient has personally given written, informed consent to participate in this study.

Exclusion Criteria:

1. The patient is considered to require postoperative chemotherapy other than capecitabine.

2. The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).

3. The patient has either simultaneous or non-simultaneous bilateral breast cancer.

4. The patient has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.

5. The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.

6. The patient has previously had an organ transplant.

7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane.

8. The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months.

9. The patient has a fever, and there is the possibility that she has an infection.

10. The patient has been shown to have metastasis to other organs.

11. The patient requires treatment for epilepsy and/or central nervous system disorders.

12. The patient is currently being treated for, or has a history of, psychiatric disease.

13. It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome.

14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Neoplasm, Residual

Intervention

Drug:
• Capecitabine
observation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival(DFS)	To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo arm.	5 years
Secondary	overall survival(OS)	To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo arm.	5 years
Secondary	medicine safety	To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo arm.	5 years