Breast CancerPhase 2PRISM-TNBCNCT06802757
Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer
A Phase 2 study testing Posaconazole, Nab-paclitaxel and Carboplatin in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. 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?
- Posaconazole, Nab-paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 1 Feb 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged ≥ 18 and ≤ 70 years old;
- first-confirmed TNBC;
- cT1cN1-3M0 or cT2-4N0-3M0;
- ECOG score 0-1 points.
Who cannot join
- Stage I or IV;
- History of previous breast cancer;
- Patients with a history of other tumors who have received systemic therapy or local radiotherapy;
- No immune system disease or connective tissue disease;
- No history of hormone therapy;
- Pregnant/lactating.
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
Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, 250117
Pengfei Qiu, +86053167626215, qiu.pf@outlook.com
About this study
Official title: A Phase II, Randomised, Open-label, Multicentre Study of Posaconazole Plus PD-1 Inhibitors and Chemotherapy Versus PD-1 Inhibitors and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. The Keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological Complete Response (pCR) rate in TNBC to over 60%, but nearly 40% of patients still do not achieve pCR. How to further improve the pCR rate in TNBC patients has become a hot topic of current research.
Posaconazole is an antibiotic used to prevent invasive Aspergillus and Candida infections and to treat oropharyngeal candidiasis. Our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict TNBC tumor progression. The investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of TNBC.
Read the detailed description
OBJECTIVES: On the basis of chemotherapy combined with immunotherapy, posaconazole was used to further improve the pathological complete response (pCR) rate of high-risk triple-negative breast cancer (TNBC), and to explore biomarkers.
OUTLINE: From April 30th, 2025 to December 31st, 2026 the investigators will recruit 72 patients with first-time diagnosed early-stage TNBC. Enrolled patients were randomly divided into experimental group and control group on a 1:1 basis. Both groups received standard neoadjuvant chemotherapy combined with immunotherapy. The experimental group was treated with posaconazole (Day 1 of Cycle 1 only: 300 mg bid; from Day 2, maintenance dose of 300 mg qd, oral administration. 21 days per treatment cycle, for a total of 8 cycles.). Standard surgical treatment was performed after 8 cycles and the surgical specimens were pathologically tested to compare the differences in pCR rates between the two groups.
- Conditions
- Breast Cancer
- Being tested
- Posaconazole, Nab-paclitaxel, Carboplatin, Anthracycline, Cyclophosphamide
- Keywords
- Triple-Negative Breast Cancer, Pathological Complete Response, Neoadjuvant Therapy, Posaconazole
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosaconazoleDrug
Day 1 of Cycle 1 only: 300 mg bid; from Day 2, maintenance dose of 300 mg qd, oral administration. 21 days per treatment cycle, for a total of 8 cycles.
Nab-paclitaxelDrug
Nab-paclitaxel 260mg/m^2 d1 q21d
CarboplatinDrug
Carboplatin AUC=5-6 d1 q21d
AnthracyclineDrug
Epirubicin 100mg/m^2 d1 q21d or Doxorubicin 60mg/m^2 d1 q21d
CyclophosphamideDrug
Cyclophosphamide 600mg/m^2 d1 q21d
PD-1 inhibitorsDrug
Toripalimab, Pembrolizumab and Camrelizumab, etc.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + PD-1 inhibitors | Other | Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with PD-1 inhibitors Receives: Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Anthracycline; Drug: Cyclophosphamide; Drug: PD-1 inhibitors |
| Chemotherapy + PD-1 inhibitors+Posaconazole | Experimental | Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with PD-1 inhibitors and posaconazole Receives: Drug: Posaconazole; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Anthracycline; Drug: Cyclophosphamide; Drug: PD-1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
Expected 25% increase in pCR rate
Measured: 24 weeks
Secondary outcomes (5)
Breast pathological complete response
Measured: 24 weeks
Objective response rate
Measured: 24 weeks
3-year event-free survival rate
Measured: After a median follow-up of 3 years
Survival rate
Measured: After a median follow-up of 3 years
Security
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2028 (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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802757
- Sponsor's protocol ID
- POS-PEM-Ⅱ-NEO-TNBC
- Acronym
- PRISM-TNBC
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Open-label, Multicentre Study of Posaconazole Plus PD-1 Inhibitors and Chemotherapy Versus PD-1 Inhibitors and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06802757
- Acronym / sponsor ID
- PRISM-TNBC / POS-PEM-Ⅱ-NEO-TNBC
- Conditions
- Breast Cancer
- Keywords
- Triple-Negative Breast Cancer, Pathological Complete Response, Neoadjuvant Therapy, Posaconazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 31 Jan 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.
Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. The Keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological Complete Response (pCR) rate in TNBC to over 60%, but nearly 40% of patients still do not achieve pCR. How to further improve the pCR rate in TNBC patients has become a hot topic of current research.
Posaconazole is an antibiotic used to prevent invasive Aspergillus and Candida infections and to treat oropharyngeal candidiasis. Our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict TNBC tumor progression. The investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of TNBC.
Detailed description
OBJECTIVES: On the basis of chemotherapy combined with immunotherapy, posaconazole was used to further improve the pathological complete response (pCR) rate of high-risk triple-negative breast cancer (TNBC), and to explore biomarkers.
OUTLINE: From April 30th, 2025 to December 31st, 2026 the investigators will recruit 72 patients with first-time diagnosed early-stage TNBC. Enrolled patients were randomly divided into experimental group and control group on a 1:1 basis. Both groups received standard neoadjuvant chemotherapy combined with immunotherapy. The experimental group was treated with posaconazole (Day 1 of Cycle 1 only: 300 mg bid; from Day 2, maintenance dose of 300 mg qd, oral administration. 21 days per treatment cycle, for a total of 8 cycles.). Standard surgical treatment was performed after 8 cycles and the surgical specimens were pathologically tested to compare the differences in pCR rates between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + PD-1 inhibitors | Other | Drug: Nab-paclitaxel, Drug: Carboplatin, Drug: Anthracycline, Drug: Cyclophosphamide, Drug: PD-1 inhibitorsNab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with PD-1 inhibitors |
| Chemotherapy + PD-1 inhibitors+Posaconazole | Experimental | Drug: Posaconazole, Drug: Nab-paclitaxel, Drug: Carboplatin, Drug: Anthracycline, Drug: Cyclophosphamide, Drug: PD-1 inhibitorsNab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with PD-1 inhibitors and posaconazole |
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 ≥ 18 and ≤ 70 years old;
- first-confirmed TNBC;
- cT1cN1-3M0 or cT2-4N0-3M0;
- ECOG score 0-1 points.
Key exclusion criteria (6 listed)
- Stage I or IV;
- History of previous breast cancer;
- Patients with a history of other tumors who have received systemic therapy or local radiotherapy;
- No immune system disease or connective tissue disease;
- No history of hormone therapy;
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 |
|---|---|---|
| PosaconazoleDay 1 of Cycle 1 only: 300 mg bid; from Day 2, maintenance dose of 300 mg qd, oral administration. 21 days per treatment cycle, for a total of 8 cycles. | Drug | Chemotherapy + PD-1 inhibitors+Posaconazole |
| Nab-paclitaxelNab-paclitaxel 260mg/m^2 d1 q21d | Drug | Chemotherapy + PD-1 inhibitors, Chemotherapy + PD-1 inhibitors+Posaconazole |
| CarboplatinCarboplatin AUC=5-6 d1 q21d | Drug | Chemotherapy + PD-1 inhibitors, Chemotherapy + PD-1 inhibitors+Posaconazole |
| AnthracyclineEpirubicin 100mg/m^2 d1 q21d or Doxorubicin 60mg/m^2 d1 q21d | Drug | Chemotherapy + PD-1 inhibitors, Chemotherapy + PD-1 inhibitors+Posaconazole |
| CyclophosphamideCyclophosphamide 600mg/m^2 d1 q21d | Drug | Chemotherapy + PD-1 inhibitors, Chemotherapy + PD-1 inhibitors+Posaconazole |
| PD-1 inhibitorsToripalimab, Pembrolizumab and Camrelizumab, etc. | Drug | Chemotherapy + PD-1 inhibitors, Chemotherapy + PD-1 inhibitors+Posaconazole |
Primary outcome
Pathological Complete Response
Time frame: 24 weeks
Expected 25% increase in pCR rate
5 secondary outcomes
Breast pathological complete response
Time frame: 24 weeks
Objective response rate
Time frame: 24 weeks
3-year event-free survival rate
Time frame: After a median follow-up of 3 years
Survival rate
Time frame: After a median follow-up of 3 years
Security
Time frame: 24 weeks
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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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 Posaconazole, Nab-paclitaxel and Carboplatin in people with Breast Cancer, run by Shandong Cancer Hospital and Institute 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 4 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 4 Nov 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?
Contact Pengfei Qiu, MD (+86053167626215, qiu.pf@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (time frame: 24 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 4 Nov 2026.