Triple-negative Breast CancerPhase 2NCT03775928
Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer
A Phase 2 study testing Apatinib and capecitabine in people with Triple-negative Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- Apatinib and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2018to 1 Oct 2021
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age：18~75 years;
- Triple-negative breast cancer (TNBC) confirmed by histology examination;
- patients had received first-line combination chemotherapy for advanced metastatic disease, and had a complete response, partial response or stable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria;
- received endocrine therapy for metastatic disease before first-line chemotherapy were allowed;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- A life expectancy of more than 12 weeks;
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- Baseline blood routine examination in accordance with the following criteria : ANC≥1.5×109/L，PLT≥90×109/L，Hb≥90g/L;
- Liver and renal function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), or alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases.
- the creatinine clearance rate calculated greater than 60 mL/min;
- Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, and they are willing to take effective contraceptive methods During the trial and within 8 weeks after the last dose;
- Obtain informed consent from patients before starting any research-related operations and treatments to confirm that patients are willing to participate in this study and comply with research-related requirements.
Who cannot join
- Metastasis/recurrence occurs within 6 months of adjuvant chemotherapy;
- controlled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg;
- urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;
- abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN);
- Pregnant or lactating woman;
- Symptomatic brain parenchymal and/or pia mater metastases without treatment and control;
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- Patients with Other malignant tumors in the past 5 years, except for fully treated cervical carcinoma in situ, cutaneous squamous cell carcinoma or well-controlled localized basal cell skin cancer;
- Mental illness or other condition that affects patient compliance;
- serious and uncontrollable systemic diseases (eg clinically significant cardiovascular disease, lung or metabolic disease, arteriovenous thrombosis, etc.) happened recently;
- Can not take or absorb oral drugs;
- Receiving any other testing drugs, or participating in other clinical trial 30 days before being enrolled in this trial;
- The patient has previously received treatment with an anti-angiogenic drug (whether adjuvant or palliative);
- Known or suspected to be allergic to any research drug or excipient;
- Any other researcher believes that it is not appropriate to participate in this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital, ChineseAMS
Beijing, Beijing Municipality, 100021
Binghe Xu, PhD, 86-10-87788826, xubinghe@medmail.com
Bo Lan, PhD, 86-10-87788114, daxiaolanbo@163.com
About this study
Official title: Phase Ⅱ Study of Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer
Read the detailed description
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Maintenance therapy after combination chemotherapy can prolong the disease control time in patients with advanced TNBC. How to prolong the disease control time of patients with advanced TNBC without affecting the quality of life has become the focus of current research.
Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. The results of this study will help explore the new treatment of small molecule anti-angiogenic drugs for TNBC maintenance therapy, and provide some new ideas for improving individualized treatment options for patients with advanced TNBC.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- Apatinib, capecitabine
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
apatinib 425mg qd po
capecitabineDrug
capecitabine 1000mg/m2 bid d1-d14
| Study group | Role | What they receive |
|---|---|---|
| Apatinib + Capecitabine | Experimental | Apatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d Receives: Drug: Apatinib; Drug: capecitabine |
| Capecitabine | Active comparator | capecitabine 1000mg/m2 bid d1-14, q21d Receives: Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Time from randomization to disease progression or death for any cause
Measured: up to 6 months
Secondary outcomes (3)
overall survival
Time from randomization to death for any cause
Measured: up to 6 months
tine to progress
Time from randomization to disease progression
Measured: up to 6 months
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start18 Dec 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775928
- Sponsor's protocol ID
- LB
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03775928
- Acronym / sponsor ID
- LB
- Conditions
- Triple-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 18 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 14 Dec 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.
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer
Detailed description
Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Maintenance therapy after combination chemotherapy can prolong the disease control time in patients with advanced TNBC. How to prolong the disease control time of patients with advanced TNBC without affecting the quality of life has become the focus of current research.
Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. The results of this study will help explore the new treatment of small molecule anti-angiogenic drugs for TNBC maintenance therapy, and provide some new ideas for improving individualized treatment options for patients with advanced TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib + Capecitabine | Experimental | Drug: Apatinib, Drug: capecitabineApatinib 425mg d1-21+ capecitabine 1000mg/m2 bid d1-14, q21d |
| Capecitabine | Active comparator | Drug: capecitabinecapecitabine 1000mg/m2 bid d1-14, q21d |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age：18~75 years;
- Triple-negative breast cancer (TNBC) confirmed by histology examination;
- patients had received first-line combination chemotherapy for advanced metastatic disease, and had a complete response, partial response or stable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria;
- received endocrine therapy for metastatic disease before first-line chemotherapy were allowed;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (14 listed)
- Metastasis/recurrence occurs within 6 months of adjuvant chemotherapy;
- controlled high blood pressure, systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg;
- urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;
- abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN);
- Pregnant or lactating woman;
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 |
|---|---|---|
| Apatinibapatinib 425mg qd po | Drug | Apatinib + Capecitabine |
| capecitabinecapecitabine 1000mg/m2 bid d1-d14 | Drug | Apatinib + Capecitabine, Capecitabine |
Primary outcome
progression-free survival
Time frame: up to 6 months
Time from randomization to disease progression or death for any cause
3 secondary outcomes
overall survival
Time frame: up to 6 months
tine to progress
Time frame: up to 6 months
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Binghe Xu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Apatinib and capecitabine in people with Triple-negative Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 11 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 14 Dec 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?
Contact Binghe Xu (86-87788826 ext. 861087788120, xubinghe@medmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: up to 6 months). 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 14 Dec 2018.