HER2-positive Breast CancerPhase 2NCT03684863
Capecitabine in HER-2 Positive Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy
A Phase 2 study testing Capecitabine in people with HER2-positive Breast Cancer, run by Shandong Cancer Hospital and Institute.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 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
- Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis.
- Stage I-IIIB at the first diagnosis and underwent curative resection.
- 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
- The patient has been confirmed to be HER2 positive. etc.
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- The patient's general performance status is 0 to 1.
- The patient must have no carry-over of efficacy from any previous treatment.
- The patient has maintained sufficient organ function to permit valid evaluation.
- The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment.
- The patient's creatinine clearance is higher than 50 ml/min
- The patient has personally given written, informed consent to participate in this study.
Who cannot join
- The patient is considered to require postoperative chemotherapy other than capecitabine.
- The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).
- The patient has either simultaneous or non-simultaneous bilateral breast cancer.
- 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.
- The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.
- The patient has previously had an organ transplant.
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- 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.
- 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.
- The patient has a fever, and there is the possibility that she has an infection.
- The patient has been shown to have metastasis to other organs.
- The patient requires treatment for epilepsy and/or central nervous system disorders.
- The patient is currently being treated for, or has a history of, psychiatric disease.
- 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.
- For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
observation
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | No intervention | Not described |
| capecitabine | Experimental | Not described Receives: Drug: Capecitabine |
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 placebo 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 placebo arm.
Measured: 5 years
medicine safety
To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or placebo 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 posted26 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies 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
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684863
- Sponsor's protocol ID
- ShandongCHI-06
- Status last verified
- Sep 2018
- First submitted
- 26 Aug 2018
- Last updated
- 26 Sep 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 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03684863
- Acronym / sponsor ID
- ShandongCHI-06
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 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, as a postoperative adjuvant chemotherapy, for HER-2 positive 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 |
|---|---|---|
| Standard therapy | No intervention | – |
| capecitabine | Experimental | Drug: Capecitabine |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis.
- Stage I-IIIB at the first diagnosis and underwent curative resection.
- 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.
- The patient has been confirmed to be HER2 positive. etc.
- The patient's general performance status is 0 to 1.
Key exclusion criteria (14 listed)
- The patient is considered to require postoperative chemotherapy other than capecitabine.
- The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).
- The patient has either simultaneous or non-simultaneous bilateral breast cancer.
- 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.
- The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.
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 |
|---|---|---|
| Capecitabineobservation | Drug | capecitabine |
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 placebo 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 26 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with HER2-positive Breast Cancer, run by Shandong Cancer Hospital and Institute.
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 12 inclusion and 14 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhiyong Yu, PhD (86053167626234, drzhiyongyu@aliyun.com), or a site near the patient. 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 26 Sep 2018.