Metastatic Triple-Negative Breast CancerPhase 2NCT05089643
Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer
A Phase 2 study testing Anlotinib and Capecitabine in people with Metastatic Triple-Negative Breast Cancer, run by Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm phase II clinical study of capecitabine 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 70 years, women only
- Conditions the study is for
- Metastatic Triple-Negative Breast Cancer
- What is being tested?
- Anlotinib and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 11 Apr 2019to 31 Dec 2022
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged between 18 and 70;
- Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER < 10% positive and PR < 10% positive.
- Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;
- There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)
Who cannot join
- The number of previous treatment lines (including postoperative adjuvant therapy) >4 lines
- symptomatic central system metastases.Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).
- New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peng Yuan, M.D., +8613501270834, yuanpeng01@hotmail.com
Peng Yuan, M.D.
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Peng Yuan, M.D.
About this study
Official title: Anrotinib in Combination With Capecitabine in the Single-arm, Open Phase II Treatment of Relapsed or Metastatic Triple-negative Breast Cancer Clinical Research
The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
Read the detailed description
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
- Conditions
- Metastatic Triple-Negative Breast Cancer
- Being tested
- Anlotinib, 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.
AnlotinibDrug
Before breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill.
CapecitabineDrug
Capecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable.
| Study group | Role | What they receive |
|---|---|---|
| CA | Experimental | Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D Receives: Drug: Anlotinib; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
he 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 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
adverse events
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 posted22 Oct 2021
- Study start11 Apr 2019
- Primary completion15 Apr 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 35 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089643
- Sponsor's protocol ID
- NCC1969
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2021
- Last updated
- 10 Jan 2022
- 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 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anrotinib in Combination With Capecitabine in the Single-arm, Open Phase II Treatment of Relapsed or Metastatic Triple-negative Breast Cancer Clinical Research
- ClinicalTrials.gov ID
- NCT05089643
- Acronym / sponsor ID
- NCC1969
- Conditions
- Metastatic Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Oct 2021 (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 capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
Detailed description
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the capecitabine 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 |
|---|---|---|
| CA | Experimental | Drug: Anlotinib, Drug: CapecitabineAnlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female aged between 18 and 70;
- Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER < 10% positive and PR < 10% positive.
- Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;
- There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)
Key exclusion criteria (3 listed)
- The number of previous treatment lines (including postoperative adjuvant therapy) >4 lines
- symptomatic central system metastases.Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).
- New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation
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 |
|---|---|---|
| AnlotinibBefore breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill. | Drug | CA |
| CapecitabineCapecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable. | Drug | CA |
Primary outcome
Objective Response Rate
Time frame: up to 1 year after the last patient enrolled
he 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
Time frame: up to 1 year after the last patient enrolled
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 10 Jan 2022.
Related trials for Metastatic Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 2
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
Triple-negative Breast Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib and Capecitabine in people with Metastatic Triple-Negative Breast Cancer, run by Chinese Academy of Medical Sciences at 2 sites 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 4 inclusion and 3 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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, doctor (18612621749, sunlight_1985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (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 10 Jan 2022.