Breast CancerPhase 2/3ArtemisNCT04803539
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC
A Phase 2/3 study testing capecitabine and capecitabine + camrelizumab + apatinib in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- capecitabine and capecitabine + camrelizumab + apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Sep 2033
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years-old at the time of consent to participate this trial
- Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER <=1%, PR <=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
- positive ctDNA after curative surgery and/or adjuvant chemotherapy
- ECOG 0-2
- If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
- Patient receives adjuvant chemotherapy according to the NCCN guidelines
- Patient has available tumor tissue from the surgical specimen for next generation sequencing(NCS)
- Patient agrees to give blood samples for ctDNA tests every 3 months in 5 years
Who cannot join
- Patient has previously received any PD1/PDL1 blockage treatment
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
- Patient participates another interventional clinical trial
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
- Patient with autoimmune disease preventing the use of camrelizumab
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sunyat-sen Memorial Hospital
Guandong, Guangdong
shunying Li, +86-15915939702, lishunying@foxmail.com
About this study
Official title: A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)
Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
- Conditions
- Breast Cancer
- Being tested
- capecitabine, capecitabine + camrelizumab + apatinib
- Keywords
- stage II-III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial)
capecitabine + camrelizumab + apatinibDrug
Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Active comparator | Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year Receives: Drug: capecitabine |
| Capecitabine + Apatinib + Camrelizumab | Experimental | Patients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day, Camrelizumab 200mg intravenously, once every two weeks (Q2W), oral apatinib, 250mg, PO, qd for 1 year Receives: Drug: capecitabine + camrelizumab + apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease Free Survival(IDFS)
Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Measured: 60 months
Secondary outcomes (4)
Distant disease-free survival(DDFS)
Distant Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Measured: 60 months
Overall Survival
Overall Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Measured: 60 months
Brain metastasis rate
Brain metastasis rate for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
Measured: 60 months
The rate of adverse effects(AEs)
AEs related to apatinib and/or camrelizumab
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Liu Qiang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Qiang Liu, PhD, Principal investigator, Sunyat-sen Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803539
- Sponsor's protocol ID
- SunYatsenU2H-LQ4
- Acronym
- Artemis
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After Adjuvant Chemotherapy in TNBC (Artemis)
- ClinicalTrials.gov ID
- NCT04803539
- Acronym / sponsor ID
- Artemis / SunYatsenU2H-LQ4
- Conditions
- Breast Cancer
- Keywords
- stage II-III
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2033 (estimated)
- First posted
- 17 Mar 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.
Circulating tumor DNA (ctDNA) has been demonstrated to be an effective prognostic marker in breast cancer. Various studies have shown that early TNBC breast cancer patients with positive ctDNA have high risk of cancer recurrence and worse prognosis. This study aimed to identify TNBC patients with positive ctDNA and initiate boost therapy in these high risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Active comparator | Drug: capecitabinePatients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day by mouth for 1 year |
| Capecitabine + Apatinib + Camrelizumab | Experimental | Drug: capecitabine + camrelizumab + apatinibPatients assigned to this group will receive oral capecitabine at a dose of 650 mg/m2 twice a day, Camrelizumab 200mg intravenously, once every two weeks (Q2W), oral apatinib, 250mg, PO, qd for 1 year |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is ≥ 18 years-old at the time of consent to participate this trial
- Stage II - III primary triple negative breast cancer patients(TNBC), TNBC is defined as ER <=1%, PR <=1%；HER2 receptor IHC=1, or IHC=2 and FISH negative.
- positive ctDNA after curative surgery and/or adjuvant chemotherapy
- ECOG 0-2
- If indicated, patient agree to receive adjuvant radiotherapy according to the institutional guidelines
Key exclusion criteria (7 listed)
- Patient has previously received any PD1/PDL1 blockage treatment
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition)
- Patient participates another interventional clinical trial
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 3 years before randomization
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 |
|---|---|---|
| capecitabinecapecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial) | Drug | Capecitabine |
| capecitabine + camrelizumab + apatinibCamrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study | Drug | Capecitabine + Apatinib + Camrelizumab |
Primary outcome
Invasive Disease Free Survival(IDFS)
Time frame: 60 months
Invasive Disease-Free Survival for capecitabine versus capecitabine + apatinib + camrelizumab in ctDNA-positive stage II-III TNBC patients, using STEEP criteria
4 secondary outcomes
Distant disease-free survival(DDFS)
Time frame: 60 months
Overall Survival
Time frame: 60 months
Brain metastasis rate
Time frame: 60 months
The rate of adverse effects(AEs)
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
Qiang Liu, PhD principal investigator
Sunyat-sen Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing capecitabine and capecitabine + camrelizumab + apatinib in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Feb 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shunying Li, MD (86-020-34071156, lishunying@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease Free Survival(IDFS) (time frame: 60 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 21 Feb 2023.