Breast Cancer - FemalePhase 2NCT07103447
Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC
A Phase 2 study testing AK112, Carboplatin, Paxlitaxel in people with Breast Cancer - Female, run by Shuangyue Liu.
Trial summary
This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer - Female
- What is being tested?
- AK112, Carboplatin, Paxlitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2025to 31 Dec 2028
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary Participation and Informed Consent: The participant voluntarily agrees to join this clinical trial, signs a written informed consent form, understands the study, and is willing to comply with all trial procedures.
- Eligibility by Age and Gender: Female participants aged ≥18 years and ≤75 years on the day of signing the informed consent form.
- Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR < 1%), and human epidermal growth factor receptor 2 (HER2) (immunohistochemistry HER2 "0~1+"; or immunohistochemistry HER2 "2+" with no amplification on HER2 FISH gene testing).
- Measurable Lesion: At least one lesion measurable according to RECIST v1.1 criteria. Participants diagnosed at an external institution agree to provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded [FFPE] tissue blocks or at least 25 unstained tumor tissue slides) for pathology review.
- Planned Surgical Treatment: Participants are scheduled to undergo definitive surgical resection of breast cancer, including either breast-conserving surgery or mastectomy, along with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND), and are planned to receive neoadjuvant chemotherapy.
Who cannot join
- Prior Anti-Cancer Treatments.
- Received systemic anti-cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (within 2 weeks for small molecule targeted therapies), or biological agent treatment within 4 weeks before enrollment.
- Received palliative local treatments within 2 weeks before enrollment.
- Received systemic non-specific immune modulatory treatments (e.g., interleukins, interferons, thymopeptides) within 2 weeks before enrollment.
- Received traditional Chinese medicine or Chinese patent medicines with anti-cancer indications within 2 weeks before enrollment.
- Prior PD-1/PD-L1 Treatment.
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- Previously received treatment with PD-1 inhibitors or PD-L1 inhibitors.
- Concurrent Participation in Other Clinical Studies.
- Currently participating in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.
- History of Other Malignancies:
- Has a history of other malignant tumors within 5 years prior to enrollment or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and thyroid cancer.
- Active Autoimmune Diseases: Has active autoimmune diseases that required systemic treatment (such as corticosteroids) within 2 years before enrollment, or has autoimmune diseases that the investigator judges may recur or require planned treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Single-Arm Study of AK112 in Combination With Albumin-Bound Paclitaxel and Carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer
This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.
- Conditions
- Breast Cancer - Female
- Being tested
- AK112, Carboplatin, Paxlitaxel
- Keywords
- AK112 combining chemothrapy, neoadjuvant therapy, TNBC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112, Carboplatin, PaxlitaxelDrug
The combination of AK112, a platinum-based chemotherapy agent, and Paxlitaxel is administered every three weeks as a neoadjuvant treatment for triple-negative breast cancer. After completing six cycles of this regimen, the participant undergoes surgical treatment.
| Study group | Role | What they receive |
|---|---|---|
| AK112 combining Nab-paclitaxel and carboplatin | Experimental | Not described Receives: Drug: AK112, Carboplatin, Paxlitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathological complete response
Measured: After surgery, within an average of 2 weeks
Secondary outcomes (1)
ORR
After complete 6 cycles of neoadjuvant chemotherapy in combination with AK112
Measured: Two weeks after completing 6 cycles of neoadjuvant therapy (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start10 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - FemaleStudies 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuangyue Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuangyue Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103447
- Sponsor's protocol ID
- WestChinaL112
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent documents approved by the ethics committee did not cover broad data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Study of AK112 in Combination With Albumin-Bound Paclitaxel and Carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07103447
- Acronym / sponsor ID
- WestChinaL112
- Conditions
- Breast Cancer - Female
- Keywords
- AK112 combining chemothrapy, neoadjuvant therapy, TNBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shuangyue LiuUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 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.
This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally 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 |
|---|---|---|
| AK112 combining Nab-paclitaxel and carboplatin | Experimental | Drug: AK112, Carboplatin, Paxlitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary Participation and Informed Consent: The participant voluntarily agrees to join this clinical trial, signs a written informed consent form, understands the study, and is willing to comply with all trial procedures.
- Eligibility by Age and Gender: Female participants aged ≥18 years and ≤75 years on the day of signing the informed consent form.
- Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR < 1%), and human epidermal growth factor receptor 2 (HER2) (immunohistochemistry HER2 "0~1+"; or immunohistochemistry HER2 "2+" with no amplification on HER2 FISH gene testing).
- Measurable Lesion: At least one lesion measurable according to RECIST v1.1 criteria. Participants diagnosed at an external institution agree to provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded [FFPE] tissue blocks or at least 25 unstained tumor tissue slides) for pathology review.
- Planned Surgical Treatment: Participants are scheduled to undergo definitive surgical resection of breast cancer, including either breast-conserving surgery or mastectomy, along with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND), and are planned to receive neoadjuvant chemotherapy.
Key exclusion criteria (12 listed)
- Prior Anti-Cancer Treatments.
- Received systemic anti-cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (within 2 weeks for small molecule targeted therapies), or biological agent treatment within 4 weeks before enrollment.
- Received palliative local treatments within 2 weeks before enrollment.
- Received systemic non-specific immune modulatory treatments (e.g., interleukins, interferons, thymopeptides) within 2 weeks before enrollment.
- Received traditional Chinese medicine or Chinese patent medicines with anti-cancer indications within 2 weeks before enrollment.
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 |
|---|---|---|
| AK112, Carboplatin, PaxlitaxelThe combination of AK112, a platinum-based chemotherapy agent, and Paxlitaxel is administered every three weeks as a neoadjuvant treatment for triple-negative breast cancer. After completing six cycles of this regimen, the participant undergoes surgical treatment. | Drug | AK112 combining Nab-paclitaxel and carboplatin |
Primary outcome
pCR
Time frame: After surgery, within an average of 2 weeks
pathological complete response
1 secondary outcome
ORR
Time frame: Two weeks after completing 6 cycles of neoadjuvant therapy (each cycle is 21 days)
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 5 Aug 2025.
- Individual participant dataSharing planned: No. The informed consent documents approved by the ethics committee did not cover broad data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK112, Carboplatin, Paxlitaxel in people with Breast Cancer - Female, run by Shuangyue Liu.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ting Luo (86 +18980606230, luoting@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: After surgery, within an average of 2 weeks). 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 5 Aug 2025.