Pathologic Residual Cancer CellsPhase 2NCT03703427
Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy
A Phase 2 study testing Capecitabine, Oral, 500 Mg and Vinorelbine Tartrate Oral in people with Pathologic Residual Cancer Cells, run by Zhiyong Yu at 1 site in China.
Trial summary
This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Pathologic Residual Cancer Cells
- What is being tested?
- Capecitabine, Oral, 500 Mg and Vinorelbine Tartrate Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2018to Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 and paclitaxel or docetaxel; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells.The previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy 4. The patient has high risk: young;triple negtive breast caner; positive axillary lymphnode;HER-2 positive;ect 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.
Who cannot join
- 1. The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine. 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhiyong Yu
Jinan, Shandong
Zhiyong Yu, PhD, 86053167626958 ext. 86053167626958, drzhiyongyu@aliyun.com
Leilei Wang, MD, 86053167626958 ext. 86053167626958, lilyhappy1015@163.com
About this study
Official title: Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID
This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.
- Conditions
- Pathologic Residual Cancer Cells
- Being tested
- Capecitabine, Oral, 500 Mg, Vinorelbine Tartrate Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, Oral, 500 MgDrug
1250mg/m2，d1-d14，q3w
Vinorelbine Tartrate OralDrug
60mg/m2，d1；d8；q3w
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | Not described Receives: Drug: Capecitabine, Oral, 500 Mg |
| Vinorelbine | Experimental | Not described Receives: Drug: Vinorelbine Tartrate Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival(DFS)
To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.
Measured: 5 years
Secondary outcomes (2)
overall survival(OS)
To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.
Measured: 5 years
medicine safety
To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic Residual Cancer CellsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyong Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703427
- Sponsor's protocol ID
- ShandongCHI-07
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID
- ClinicalTrials.gov ID
- NCT03703427
- Acronym / sponsor ID
- ShandongCHI-07
- Conditions
- Pathologic Residual Cancer Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhiyong YuUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: Capecitabine, Oral, 500 Mg |
| Vinorelbine | Experimental | Drug: Vinorelbine Tartrate Oral |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 and paclitaxel or docetaxel; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells.The previously adminstered preoperative chemotherapy must have involved 8 cycles of EC-T or 6 cycles of TEC.If HER-2 is positive, trastuzumab is applied with T chemotherapy 4. The patient has high risk: young;triple negtive breast caner; positive axillary lymphnode;HER-2 positive;ect 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.
Key exclusion criteria (1 listed)
- 1. The patient is considered to require postoperative chemotherapy other than capecitabine and vinorelbine. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine, Oral, 500 Mg1250mg/m2，d1-d14，q3w | Drug | Capecitabine |
| Vinorelbine Tartrate Oral60mg/m2，d1；d8；q3w | Drug | Vinorelbine |
Primary outcome
disease free survival(DFS)
Time frame: 5 years
To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm.
2 secondary outcomes
overall survival(OS)
Time frame: 5 years
medicine safety
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Oral, 500 Mg and Vinorelbine Tartrate Oral in people with Pathologic Residual Cancer Cells, run by Zhiyong Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival(DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.