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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HER2-positive Breast Cancer
• Intervention / Treatment: Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhiyong Yu, PhD; Phone Number: 86053167626234; Email: drzhiyongyu@aliyun.com
• Study Contact Backup: Name: Xinzhao Wang, MD; Phone Number: 86053167626234; Email: 08wangxinzhao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard therapy
Experimental: capecitabine	Drug: Capecitabine; observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival(DFS)	To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo arm.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival(OS)	To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo arm.	5 years
medicine safety	To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo arm.	5 years

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm, Residual; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: ShandongCHI-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No