Triple Negative Breast Cancer (TNBC)Phase 2NCT07394387
Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.
A Phase 2 study testing Sintilimab, Abraxane and Carboplatin in people with Triple Negative Breast Cancer (TNBC), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Background: Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and/or PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Sintilimab, Abraxane and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- 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 patients aged ≥18 and ≤70 years.
- Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging.
- At least one measurable lesion as per RECIST v1.1 criteria.
- No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
- ECOG performance status of 0 or 1.
- Adequate organ function, defined as:
Show all 21Show fewer
- Hemoglobin ≥90 g/L
- White blood cell count ≥3.5×10^9/L
- Platelet count ≥100×10^9/L
- Absolute neutrophil count ≥1.5×10^9/L
- AST and ALT ≤3× upper limit of normal (ULN)
- Total bilirubin ≤1.5× ULN
- Serum creatinine ≤1.5× ULN
- No evidence of pneumonia on chest CT
- Adequate cardiac function, defined as:
- No myocardial ischemia on ECG
- NYHA class I
- LVEF ≥55% on echocardiogram
- Normal cardiac markers (cTnI and BNP)
- Normal thyroid function (T3, T4, FT3, FT4, TSH).
- Willing and able to provide written informed consent.
Who cannot join
- Male or inflammatory breast cancer.
- Metastatic (Stage IV) breast cancer.
- History of active autoimmune or inflammatory diseases requiring systemic treatment within the past 2 years (e.g., systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis). Exceptions: type I diabetes, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis).
- Concurrent other malignancies or history of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).
- Any other serious non-malignant disease that may compromise compliance or place the patient at risk.
- Major surgery within 4 weeks prior to study initiation or anticipated need for major surgery during the study.
Show all 19Show fewer
- Prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major surgery for breast cancer.
- Known hypersensitivity to any component of the study drugs.
- Poorly controlled cardiac disease (e.g., NYHA class II+ heart failure, unstable angina, myocardial infarction within the past year, or clinically significant arrhythmias requiring intervention).
- History of interstitial lung disease (ILD), current ILD, or suspected ILD on imaging during screening.
- Active infections, including:
- HIV positive
- Active tuberculosis
- Active hepatitis B (HBV-DNA > 10^3 IU/mL)
- Active hepatitis C (HCV antibody positive with detectable HCV-RNA)
- Active autoimmune disease requiring systemic treatment.
- Dementia, significant intellectual impairment, or any psychiatric condition that impairs understanding of the informed consent.
- Unhealed wounds, ulcers, or fractures within 4 weeks prior to signing consent; or any history of clinically significant bleeding or bleeding tendency.
- Any other condition deemed by the investigator to be unsuitable for trial participation.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Wenbin Zhou, PhD, +86-138-1416-2016, zhouwenbin@njmu.edu.cn
About this study
Official title: A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.
Background:
Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and/or PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach.
Read more
Objective:
To evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR).
Study Design:
This is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization:
Cohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles.
Cohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab.
Main Measures:
The primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy.
Other important measures include:
The ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ).
The percentage of patients whose tumors shrink significantly (Objective Response Rate).
How long patients live without their cancer getting worse (Event-Free Survival).
The rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- Sintilimab, Abraxane, Carboplatin, High-intensity focused ultrasound (HIFU)
- 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.
SintilimabDrug
200 mg, administered intravenously every 3 weeks.
AbraxaneDrug
260 mg/m², administered intravenously on Day 1 of each 21-day cycle.
CarboplatinDrug
AUC = 6, administered intravenously on Day 1 of each 21-day cycle.
High-intensity focused ultrasound (HIFU)Procedure or surgery
HIFU sparse scanning. Under ultrasound guidance, the tumor and a 5mm margin of surrounding normal tissue are ablated using a point-by-point protocol (150W power, 3s irradiation per point, 5mm point spacing). Performed once.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (HIFU + Chemo + PD-1 Inhibitor) | Experimental | Not described Receives: Drug: Sintilimab; Drug: Abraxane; Drug: Carboplatin; Procedure: High-intensity focused ultrasound (HIFU) |
| Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor) | Experimental | Not described Receives: Drug: Sintilimab; Drug: Abraxane; Drug: Carboplatin; Procedure: High-intensity focused ultrasound (HIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Proportion of participants with a ≥2-fold increase in CD8+ T cell count or IFN-γ level
Measured: 2 weeks after HIFU treatment (and concurrent PD-1 inhibitor for Cohort B), which is immediately prior to the start of the first cycle of neoadjuvant chemotherapy.
Objective Response Rate (ORR)
Measured: Every 6 weeks during neoadjuvant therapy (at the end of cycles 2, 4, 6), up to up to 24 weeks
Event-Free Survival (EFS)
Measured: From enrollment until the first occurrence of an event, assessed up to 5 years.
Breast-Conserving Surgery (BCS) Rate
Measured: through study completion, an average of 1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: Baseline, 1 month post-intervention, 6 months post-intervention and at study completion (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a single-center, phase II study with two parallel cohorts. Participants are assigned to one of the following intervention sequences based on investigator discretion and clinical considerations: Cohort A: Receives High-Intensity Focused Ultrasound (HIFU) sparse scanning. Two weeks later, they begin 6 cycles of neoadjuvant therapy with albumin-bound paclitaxel + carboplatin + the PD-1 inhibitor Sintilimab. Cohort B: Receives High-Intensity Focused Ultrasound (HIFU) sparse scanning combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, they begin 6 cycles of neoadjuvant therapy with albumin-bound paclitaxel + carboplatin + Sintilimab. The primary distinction between the cohorts is the timing of the first dose of Sintilimab (before vs. concurrent with chemotherapy).
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394387
- Sponsor's protocol ID
- NJMU-BC05
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bianchini G, De Angelis C, Licata L, Gianni L. Treatment landscape of triple-negative breast cancer - expanded options, evolving needs. Nat Rev Clin Oncol. 2022 Feb;19(2):91-113. doi: 10.1038/s41571-021-00565-2. Epub 2021 Nov 9.
PubMed 34754128Hu Z, Yang XY, Liu Y, Morse MA, Lyerly HK, Clay TM, Zhong P. Release of endogenous danger signals from HIFU-treated tumor cells and their stimulatory effects on APCs. Biochem Biophys Res Commun. 2005 Sep 16;335(1):124-31. doi: 10.1016/j.bbrc.2005.07.071.
PubMed 16055092Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.
PubMed 26869049Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
PubMed 32101663
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT07394387
- Acronym / sponsor ID
- NJMU-BC05
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
Background:
Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and/or PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach.
Objective:
To evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR).
Study Design:
This is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization:
Cohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles.
Cohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab.
Main Measures:
The primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy.
Other important measures include:
The ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ).
The percentage of patients whose tumors shrink significantly (Objective Response Rate).
How long patients live without their cancer getting worse (Event-Free Survival).
The rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, phase II study with two parallel cohorts. Participants are assigned to one of the following intervention sequences based on investigator discretion and clinical considerations: Cohort A: Receives High-Intensity Focused Ultrasound (HIFU) sparse scanning. Two weeks later, they begin 6 cycles of neoadjuvant therapy with albumin-bound paclitaxel + carboplatin + the PD-1 inhibitor Sintilimab. Cohort B: Receives High-Intensity Focused Ultrasound (HIFU) sparse scanning combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, they begin 6 cycles of neoadjuvant therapy with albumin-bound paclitaxel + carboplatin + Sintilimab. The primary distinction between the cohorts is the timing of the first dose of Sintilimab (before vs. concurrent with chemotherapy).
| Arm | Type | Receives |
|---|---|---|
| Cohort A (HIFU + Chemo + PD-1 Inhibitor) | Experimental | Drug: Sintilimab, Drug: Abraxane, Drug: Carboplatin, Procedure: High-intensity focused ultrasound (HIFU) |
| Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor) | Experimental | Drug: Sintilimab, Drug: Abraxane, Drug: Carboplatin, Procedure: High-intensity focused ultrasound (HIFU) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female patients aged ≥18 and ≤70 years.
- Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging.
- At least one measurable lesion as per RECIST v1.1 criteria.
- No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
- ECOG performance status of 0 or 1.
Key exclusion criteria (19 listed)
- Male or inflammatory breast cancer.
- Metastatic (Stage IV) breast cancer.
- History of active autoimmune or inflammatory diseases requiring systemic treatment within the past 2 years (e.g., systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis). Exceptions: type I diabetes, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis).
- Concurrent other malignancies or history of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).
- Any other serious non-malignant disease that may compromise compliance or place the patient at risk.
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 |
|---|---|---|
| Sintilimab200 mg, administered intravenously every 3 weeks. | Drug | Cohort A (HIFU + Chemo + PD-1 Inhibitor), Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor) |
| Abraxane260 mg/m², administered intravenously on Day 1 of each 21-day cycle. | Drug | Cohort A (HIFU + Chemo + PD-1 Inhibitor), Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor) |
| CarboplatinAUC = 6, administered intravenously on Day 1 of each 21-day cycle. | Drug | Cohort A (HIFU + Chemo + PD-1 Inhibitor), Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor) |
| High-intensity focused ultrasound (HIFU)HIFU sparse scanning. Under ultrasound guidance, the tumor and a 5mm margin of surrounding normal tissue are ablated using a point-by-point protocol (150W power, 3s irradiation per point, 5mm point spacing). Performed once. | Procedure or surgery | Cohort A (HIFU + Chemo + PD-1 Inhibitor), Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor) |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: Through study completion, an average of 1 year
5 secondary outcomes
Proportion of participants with a ≥2-fold increase in CD8+ T cell count or IFN-γ level
Time frame: 2 weeks after HIFU treatment (and concurrent PD-1 inhibitor for Cohort B), which is immediately prior to the start of the first cycle of neoadjuvant chemotherapy.
Objective Response Rate (ORR)
Time frame: Every 6 weeks during neoadjuvant therapy (at the end of cycles 2, 4, 6), up to up to 24 weeks
Event-Free Survival (EFS)
Time frame: From enrollment until the first occurrence of an event, assessed up to 5 years.
Breast-Conserving Surgery (BCS) Rate
Time frame: through study completion, an average of 1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline, 1 month post-intervention, 6 months post-intervention and at study completion (an average of 1 year)
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 15 May 2026.
- Background: PubMed 34754128Bianchini G, De Angelis C, Licata L, Gianni L. Treatment landscape of triple-negative breast cancer - expanded options, evolving needs. Nat Rev Clin Oncol. 2022 Feb;19(2):91-113. doi: 10.1038/s41571-021-00565-2. Epub 2021 Nov 9.
- Background: PubMed 16055092Hu Z, Yang XY, Liu Y, Morse MA, Lyerly HK, Clay TM, Zhong P. Release of endogenous danger signals from HIFU-treated tumor cells and their stimulatory effects on APCs. Biochem Biophys Res Commun. 2005 Sep 16;335(1):124-31. doi: 10.1016/j.bbrc.2005.07.071.
- Background: PubMed 26869049Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.
- Background: PubMed 32101663Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
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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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
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 Sintilimab, Abraxane and Carboplatin in people with Triple Negative Breast Cancer (TNBC), run by The First Affiliated Hospital with Nanjing Medical 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 21 inclusion and 19 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 15 May 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?
Pathologic Complete Response (pCR) Rate (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07394387, which also lists 4 linked publications.
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 15 May 2026.