Triple-negative Breast CancerPhase 2ApolloNCT04501523
A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC
A Phase 2 study testing Tislelizumab and capecitabine in people with Triple-negative Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- Tislelizumab and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2020to Aug 2032
- Phase
- Phase 2
- 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
- Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.
- Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.
- ctDNA positive at baseline, after NAC or after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Written informed consent to provide research blood samples and tumor samples
- Patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctDNA detection
- No evidence of distant metastatic disease on staging scans conducted at the time of diagnosis
Who cannot join
- Previously participated in other interventional trials
- Previous malignancy within 3 years of breast cancer diagnosis
- Pregnancy or breastfeeding
- No written consent
- Unable to receive standard NAC and subsequent radiotherapy(if needed)
- Active autoimmune disease
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 Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- Tislelizumab, 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.
TislelizumabDrug
200mg, q3w, for 1 year
capecitabineDrug
600-750 mg/m2 PO Bid，continuous, for 1 year
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ctDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine Receives: Drug: Tislelizumab; Drug: capecitabine |
| B | Active comparator | ctDNA positive, non-pCR Intervention: capecitabine(standard care) Receives: Drug: capecitabine |
| C | Experimental | ctDNA positive, pCR Intervention: capecitabine Receives: Drug: capecitabine |
| D | No intervention | Follow up(standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years Disease free survival(DFS)
From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Measured: 60 months
Secondary outcomes (8)
5 years overall survival(OS)
From diagnosis to 5yrs or death; To determine 5-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Measured: 60 months
pathological complete remission(pCR) rate
pathological complete remission
Measured: 12 months
brain metastasis rate
The percentage of patients who develop brain metastasis
Measured: 60 months
objective response rate(ORR)
The percentage of patients who achieved PR+CR
Measured: 12 months
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
To determine the toxicities associated with tislelizumab in this population
Measured: 12 months
10 years DFS
To determine 10-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Measured: 120 months
10 years OS
To determine 10-year overall survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
Measured: 120 months
Relapse and metastasis rate
The percentage of patients who develop brain metastasis any relapse or metastasis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start3 Aug 2020
- Primary completionAug 2027 (estimated)
- Study completionAug 2032 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Qiang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Qiang Liu, MD, Principal investigator, Sunyat-sen Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501523
- Sponsor's protocol ID
- SunYatsenU2H-LQ3
- Acronym
- Apollo
- Status last verified
- Feb 2023
- First submitted
- 3 Aug 2020
- 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 Circulating Tumor DNA to Initiate Post-operation Boost Therapy After Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04501523
- Acronym / sponsor ID
- Apollo / SunYatsenU2H-LQ3
- Conditions
- Triple-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 6 Aug 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.
Positive circulating tumor DNA(ctDNA) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(TNBC). Our trial aims to improve the outcome of TNBC patients by using ctDNA to identify patients with high relapse risk. ctDNA positive patients will be randomized to receive boost therapy or standard therapy indicated in NCCN guidelines after NAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tislelizumab, Drug: capecitabinectDNA positive, non-pCR Intervention: Tislelizumab(anti-PD1 antibody) combined with capecitabine |
| B | Active comparator | Drug: capecitabinectDNA positive, non-pCR Intervention: capecitabine(standard care) |
| C | Experimental | Drug: capecitabinectDNA positive, pCR Intervention: capecitabine |
| D | No intervention | –Follow up(standard care) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage II-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.
- Must receive preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include those recommended by NCCN guidelines. Participants who received preoperative therapy as part of a clinical trial may enroll.
- ctDNA positive at baseline, after NAC or after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Written informed consent to provide research blood samples and tumor samples
Key exclusion criteria (6 listed)
- Previously participated in other interventional trials
- Previous malignancy within 3 years of breast cancer diagnosis
- Pregnancy or breastfeeding
- No written consent
- Unable to receive standard NAC and subsequent radiotherapy(if needed)
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 |
|---|---|---|
| Tislelizumab200mg, q3w, for 1 year | Drug | A |
| capecitabine600-750 mg/m2 PO Bid，continuous, for 1 year | Drug | A, B, C |
Primary outcome
5 years Disease free survival(DFS)
Time frame: 60 months
From diagnosis to 5yrs or DFS events; To determine 5-year disease free survival in ctDNA positive participants with confirmed triple negative breast cancer (TNBC) treated with a boost therapy or standard of care following preoperative chemotherapy
8 secondary outcomes
5 years overall survival(OS)
Time frame: 60 months
pathological complete remission(pCR) rate
Time frame: 12 months
brain metastasis rate
Time frame: 60 months
objective response rate(ORR)
Time frame: 12 months
Number of Patients with Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
10 years DFS
Time frame: 120 months
10 years OS
Time frame: 120 months
Relapse and metastasis rate
Time frame: 24 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, MD 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 study testing Tislelizumab and capecitabine in people with Triple-negative 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 7 inclusion and 6 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 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?
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 (+86-15915939702, lishunying@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years Disease free survival(DFS) (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; AzTrials last refreshed its copy on 1 Nov 2026.