Breast CancerPhase 2NCT06992336
Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy
A Phase 2 study testing Apatinib, Camrelizumab and Capecitabine in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Apatinib, Camrelizumab and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 1 Jan 2036
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II-III breast cancer patients, excluding occult breast cancer, inflammatory breast cancer, metaplasia breast cancer
- TNBC patients. TNBC was defined as ER <= 10%, PR <=10%, HER 0-1, or HER2 2+ and FISH negative.
Who cannot join
- -
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
Sun Yat-sen Memorial Hospital
Guangzhou, Guangodng
Shunying Li, PHD, 020-34071156, lishunying@foxmail.com
Ziqing Feng, Bachelor, +86-13060764510
About this study
Official title: A Phase II, Open-Label, Randomized Study Comparing Antiangiogenic Therapy Combined With Immunotherapy and Capecitabine Versus Investigator's Choice in Patients With Circulating Tumor DNA-Positive Stage II-III Triple-Negative Breast Cancer Who With Residual Disease After Neoadjuvant Therapy
Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk.
This trial aims to explore whether the combination of antiangiogenic therapy, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
- Conditions
- Breast Cancer
- Being tested
- Apatinib, Camrelizumab, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib, CamrelizumabDrug
Apatinib 8mg qd PO，357days Camrelizumab 200mg q3w 17 cycles in total (including immunotherapy used in the NAC period)
CapecitabineDrug
Capecitabine 1000 or 1250 mg/m2 BID day1-14
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Apatinib 8mg qd PO，357days Camrelizumab 200mg i.v. Q3W or immunotherapy continued as in the NAC(17cycles in total).
Capecitabine 1000 or 1250 mg/m2 BID day1-14 Receives: Drug: Apatinib, Camrelizumab; Drug: Capecitabine |
| B | Active comparator | Investigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years. Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
iDFS
invasive disease free survival
Measured: from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months.
Secondary outcomes (3)
dDFS
distant disease free survival
Measured: from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months
OS
overall survival
Measured: from randomization to any of the following events: death of any cause，assessed up to 120 months
ctDNA clearance
the rate of patients whose ctDNA are positive after surgery and turns negative after boost therapy
Measured: From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start10 Apr 2025
- Primary completion10 Apr 2031 (estimated)
- Study completion1 Jan 2036 (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.
- 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
- 430 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992336
- Sponsor's protocol ID
- SYSKY-2025-281-05
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2025
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomized Study Comparing Antiangiogenic Therapy Combined With Immunotherapy and Capecitabine Versus Investigator's Choice in Patients With Circulating Tumor DNA-Positive Stage II-III Triple-Negative Breast Cancer Who With Residual Disease After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06992336
- Acronym / sponsor ID
- SYSKY-2025-281-05
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Apr 2031 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 28 May 2025 (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.
Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk.
This trial aims to explore whether the combination of antiangiogenic therapy, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Apatinib, Camrelizumab, Drug: CapecitabineApatinib 8mg qd PO，357days Camrelizumab 200mg i.v. Q3W or immunotherapy continued as in the NAC(17cycles in total). Capecitabine 1000 or 1250 mg/m2 BID day1-14 |
| B | Active comparator | Drug: CapecitabineInvestigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage II-III breast cancer patients, excluding occult breast cancer, inflammatory breast cancer, metaplasia breast cancer
- TNBC patients. TNBC was defined as ER <= 10%, PR <=10%, HER 0-1, or HER2 2+ and FISH negative.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Apatinib, CamrelizumabApatinib 8mg qd PO，357days Camrelizumab 200mg q3w 17 cycles in total (including immunotherapy used in the NAC period) | Drug | A |
| CapecitabineCapecitabine 1000 or 1250 mg/m2 BID day1-14 | Drug | A, B |
Primary outcome
iDFS
Time frame: from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months.
invasive disease free survival
3 secondary outcomes
dDFS
Time frame: from randomization to any of the following events: distant relapse; contralateral breast caner, death of any cause，assessed up to 36 months
OS
Time frame: from randomization to any of the following events: death of any cause，assessed up to 120 months
ctDNA clearance
Time frame: From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 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 23 Oct 2026.
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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.
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, Camrelizumab and Capecitabine 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 2 inclusion and 1 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 23 Oct 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (time frame: from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any cause，assessed up to 36 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 23 Oct 2026.