Triple Negative Breast CancerPhase 2NCT04452370
Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
A Phase 2 study testing oral etoposide + anlotinib in people with Triple Negative Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic 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?
- oral etoposide + anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2020to 11 Jul 2023
- 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 between 18 and 75 year-old women; TNBC
- ECOG score: 0-1, expected survival time ≥ 3months;
- Pathologically or cytologically confirmed breast cancer;
- Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-3 standard chemotherapies after recurrence and metastasis;
- According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm，other examination >2cm);
- The patients have enough organ function. The laboratory test indexes must comply with the following requirements:
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- Blood routine: neutrophil≥1.5G/L, platelet count ≥80G/L, hemoglobin ≥90g/L
- Liver function: serum bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value when liver metastasis
- Renal function: serum creatinine ≤ 1.0times the upper limit of normal value, creatinine clearance >50ml/min（Cockcroft-Gault formula)
- Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial and 8 weeks after last administration；
- Can swallow oral drugs;
- The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
Who cannot join
- The patients in pregnancy or lactation growth period and did not take effective contraception;
- The patients who received ≥4 chemotherapies after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
- The patients with a variety of factors that affect the oral administration and absorption of drugs;
- Prior treatment with etoposide or antiangiogenic TKI (subjects with prior use of antiangiogenic macromolecules such as bevacizumab are allowed to be enrolled);
- The patients have uncontrollable mental illness；
- Serous cavity effusion (such as pleural effusion and ascites) with clinical symptoms requiring clinical intervention or stable time less than 4 weeks;
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- The patients who had serious adverse effect to oral etoposide or were allergic to etoposide.
- The patients who have only bone metastasis without other measurable lesion;
- The patients experience severe cardiovascular diseases;
- The patients experience severe upper gastrointestinal ulcer or malabsorption syndrome.
- Abnormal bone marrow functions(neutrophil<1.5G/L, platelet count <75G/L, hemoglobin <90g/L);
- Abnormal renal function(serum creatinine > 1.5 times the upper limit of normal value);
- Abnormal liver function(serum bilirubin ≤ 1.5 times the upper limit of normal value);
- The patients have uncontrollable brain metastasis;
- Active or uncontrolled infection requiring systematic treatment (except simple urinary tract infection or upper respiratory tract infection) during the 2 weeks or 2 weeks prior to enrollment;
- Previous or concurrent history of other malignant tumors.Except for the cured skin basal cell carcinoma and cervical carcinoma in situ;
- The patients do have good compliance to the therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, 100021
Peng Yuan, M.D., 86-10-8778 8114, yuanpeng01@hotmail.com
Binghe Xu, M.D.
About this study
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
Read the detailed description
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- oral etoposide + anlotinib
- 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.
oral etoposide + anlotinibDrug
Also called there is no other intervention name
anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle
| Study group | Role | What they receive |
|---|---|---|
| oral Etoposide+Anlotinib | Experimental | anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle Receives: Drug: oral etoposide + anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Measured: up to 1 year after the last patient enrolled
Secondary outcomes (2)
Progression free survival（PFS）
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Measured: up to 1 year after the last patient enrolled
Incidence and Severity of adverse events
hematologic，hepatotoxicity，Incidence of hypertension，Incidence of proteinuria
Measured: approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start23 Sep 2020
- Primary completion11 Jul 2022 (estimated)
- Study completion11 Jul 2023 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452370
- Sponsor's protocol ID
- NCC2225
- Status last verified
- Jul 2021
- First submitted
- 11 Jun 2020
- Last updated
- 21 Jul 2021
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04452370
- Acronym / sponsor ID
- NCC2225
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 11 Jul 2022 (estimated)
- Study completion
- 11 Jul 2023 (estimated)
- First posted
- 30 Jun 2020 (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 hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
Detailed description
It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral Etoposide+Anlotinib | Experimental | Drug: oral etoposide + anlotinibanlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 year-old women; TNBC
- ECOG score: 0-1, expected survival time ≥ 3months;
- Pathologically or cytologically confirmed breast cancer;
- Anthracycline- / taxane- pretreated (adjuvant, neoadjuvant) breast cancer patients who have failed from 1-3 standard chemotherapies after recurrence and metastasis;
- According to RECIST 1.1, exist at least ≥1 measurable lesion(CT >1cm，other examination >2cm);
Key exclusion criteria (17 listed)
- The patients in pregnancy or lactation growth period and did not take effective contraception;
- The patients who received ≥4 chemotherapies after recurrence and metastasis; involved in other clinical trials four weeks prior to the start of the study;
- The patients with a variety of factors that affect the oral administration and absorption of drugs;
- Prior treatment with etoposide or antiangiogenic TKI (subjects with prior use of antiangiogenic macromolecules such as bevacizumab are allowed to be enrolled);
- The patients have uncontrollable mental illness；
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 |
|---|---|---|
| oral etoposide + anlotinibAlso: there is no other intervention nameanlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle | Drug | oral Etoposide+Anlotinib |
Primary outcome
objective response rate（ORR）
Time frame: up to 1 year after the last patient enrolled
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
2 secondary outcomes
Progression free survival（PFS）
Time frame: up to 1 year after the last patient enrolled
Incidence and Severity of adverse events
Time frame: approximately 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Peng Yuan 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 oral etoposide + anlotinib in people with Triple Negative Breast Cancer, run by 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 12 inclusion and 17 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 21 Jul 2021. 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 Peng Yuan (01087787245, yuanpeng01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate（ORR） (time frame: up to 1 year after the last patient enrolled). 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 21 Jul 2021.