TNBC, Triple Negative Breast CancerNCT07523789
Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC
An observational study of TNBC, Triple Negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is an observational study that retrospectively collects data of triple-negative breast cancer patients who received neoadjuvant therapy. It compares the bpCR rate, apCR rate, and tpCR rate of patients treated with chemotherapy or immunotherapy, in order to analyze the efficacy and influencing factors of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC, Triple Negative Breast Cancer
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: TNBC patients
Who may be able to join
- (1)The patient is aged ≥18 years;(2) Both the biopsy pathology and postoperative pathology confirm the diagnosis of triple-negative breast cancer; (3) The patient has undergone complete neoadjuvant therapy; (4) After neoadjuvant therapy, the patient underwent surgical treatment and has complete postoperative pathology results; (5) The patient's basic information is complete.
Who cannot join
- (1) Bilateral breast cancer or distant metastasis; (2) History of previous malignant tumor or chemotherapy/immunotherapy; (3) Required NST not completed or no surgical treatment after NST; (4) Lack of pathological evaluation results for biopsy specimens or postoperative specimens, or postoperative pathological results not being triple negative; (5) Unable to obtain characteristic patient information, such as age and tumor stage. (6) Change in regimen during neoadjuvant therapy; (7) Lost to follow-up patients.
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
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Danni Shen, 008618136311251, shendannidoct@163.com
Jue Wang, 008618061695508, wangjue200011@njmu.edu.cn
About this study
Official title: Analysis of the Efficacy and Influencing Factors of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for Triple-Negative Breast Cancer
This study is an observational study that retrospectively collects data of triple-negative breast cancer patients who received neoadjuvant therapy. It compares the bpCR rate, apCR rate, and tpCR rate of patients treated with chemotherapy or immunotherapy, in order to analyze the efficacy and influencing factors of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer.
Read the detailed description
Breast cancer is one of the most common malignant tumors in women, with a rapidly increasing incidence rate and mortality rate globally. Triple-negative breast cancer (TNBC) refers to a type of breast cancer that lacks amplification of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2), accounting for approximately 15% to 20% of all breast cancer types. It is characterized by high aggressiveness, rapid recurrence and metastasis, difficult treatment, and high mortality rate. The main treatment methods for TNBC include chemotherapy, surgery, and neoadjuvant therapy. Neoadjuvant therapy is an important component of TNBC treatment, which can rapidly control tumor burden, reduce the risk of distant metastasis, increase surgical opportunities, and facilitate preoperative assessment of tumor response to drugs, thereby evaluating the effectiveness of treatment regimens and guiding the selection of postoperative treatment plans. Currently, the standard neoadjuvant therapy regimen for TNBC is based on chemotherapy combined with immunotherapy or targeted therapy.
In recent years, the application of immunotherapy in triple-negative breast cancer has gained increasing attention. Based on the phase III clinical study KEYNOTE-522, the PD-1 inhibitor pembrolizumab has been approved for neoadjuvant and adjuvant therapy of triple-negative breast cancer.
Preliminary data from the KEYNOTE-522 study indicate that, in neoadjuvant therapy, the combination of pembrolizumab significantly improves the pathologic complete response (pCR) rate and 3-year event-free survival (EFS) rate compared to chemotherapy alone. The study results suggest that immunotherapy has advantages in improving the prognosis of triple-negative breast cancer.
This study retrospectively collected data on triple-negative breast cancer patients who received neoadjuvant therapy based on inclusion and exclusion criteria, including complete data on diagnosis age, clinical tumor stage, clinical lymph node stage, Ki-67 level, HER-2 expression, surgical method after neoadjuvant therapy, and postoperative pathology. The study categorized neoadjuvant efficacy into breast pathological complete response, axillary pathological complete response, and overall pathological complete response. It compared and analyzed the bpCR rate, apCR rate, and tpCR rate of patients with different clinical characteristics to evaluate the efficacy of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer. Binary logistic regression analysis was used to investigate the influencing factors of neoadjuvant efficacy. Additionally, this study established a set of subgroup analyses to explore the efficacy and influencing factors of albumin-bound paclitaxel weekly therapy and three-week therapy in immunotherapy.
- Conditions
- TNBC, Triple Negative Breast Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy group | Patients with triple-negative breast cancer who underwent neoadjuvant chemotherapy | |
| Immunotherapy group | Patients with triple-negative breast cancer who underwent neoadjuvant Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
The proportion of patients who achieved pathological complete response after undergoing complete neoadjuvant therapy and subsequent surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC, Triple Negative Breast CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue Wang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Jue Wang, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523789
- Sponsor's protocol ID
- Neoadjuvant Therapy for TNBC
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy and Influencing Factors of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07523789
- Acronym / sponsor ID
- Neoadjuvant Therapy for TNBC
- Conditions
- TNBC, Triple Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 13 Apr 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.
This study is an observational study that retrospectively collects data of triple-negative breast cancer patients who received neoadjuvant therapy. It compares the bpCR rate, apCR rate, and tpCR rate of patients treated with chemotherapy or immunotherapy, in order to analyze the efficacy and influencing factors of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer.
Detailed description
Breast cancer is one of the most common malignant tumors in women, with a rapidly increasing incidence rate and mortality rate globally. Triple-negative breast cancer (TNBC) refers to a type of breast cancer that lacks amplification of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2), accounting for approximately 15% to 20% of all breast cancer types. It is characterized by high aggressiveness, rapid recurrence and metastasis, difficult treatment, and high mortality rate. The main treatment methods for TNBC include chemotherapy, surgery, and neoadjuvant therapy. Neoadjuvant therapy is an important component of TNBC treatment, which can rapidly control tumor burden, reduce the risk of distant metastasis, increase surgical opportunities, and facilitate preoperative assessment of tumor response to drugs, thereby evaluating the effectiveness of treatment regimens and guiding the selection of postoperative treatment plans. Currently, the standard neoadjuvant therapy regimen for TNBC is based on chemotherapy combined with immunotherapy or targeted therapy.
In recent years, the application of immunotherapy in triple-negative breast cancer has gained increasing attention. Based on the phase III clinical study KEYNOTE-522, the PD-1 inhibitor pembrolizumab has been approved for neoadjuvant and adjuvant therapy of triple-negative breast cancer.
Preliminary data from the KEYNOTE-522 study indicate that, in neoadjuvant therapy, the combination of pembrolizumab significantly improves the pathologic complete response (pCR) rate and 3-year event-free survival (EFS) rate compared to chemotherapy alone. The study results suggest that immunotherapy has advantages in improving the prognosis of triple-negative breast cancer.
This study retrospectively collected data on triple-negative breast cancer patients who received neoadjuvant therapy based on inclusion and exclusion criteria, including complete data on diagnosis age, clinical tumor stage, clinical lymph node stage, Ki-67 level, HER-2 expression, surgical method after neoadjuvant therapy, and postoperative pathology. The study categorized neoadjuvant efficacy into breast pathological complete response, axillary pathological complete response, and overall pathological complete response. It compared and analyzed the bpCR rate, apCR rate, and tpCR rate of patients with different clinical characteristics to evaluate the efficacy of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer. Binary logistic regression analysis was used to investigate the influencing factors of neoadjuvant efficacy. Additionally, this study established a set of subgroup analyses to explore the efficacy and influencing factors of albumin-bound paclitaxel weekly therapy and three-week therapy in immunotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy group | – | –Patients with triple-negative breast cancer who underwent neoadjuvant chemotherapy |
| Immunotherapy group | – | –Patients with triple-negative breast cancer who underwent neoadjuvant Immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TNBC patients
Key inclusion criteria (1 listed)
- (1)The patient is aged ≥18 years;(2) Both the biopsy pathology and postoperative pathology confirm the diagnosis of triple-negative breast cancer; (3) The patient has undergone complete neoadjuvant therapy; (4) After neoadjuvant therapy, the patient underwent surgical treatment and has complete postoperative pathology results; (5) The patient's basic information is complete.
Key exclusion criteria (1 listed)
- (1) Bilateral breast cancer or distant metastasis; (2) History of previous malignant tumor or chemotherapy/immunotherapy; (3) Required NST not completed or no surgical treatment after NST; (4) Lack of pathological evaluation results for biopsy specimens or postoperative specimens, or postoperative pathological results not being triple negative; (5) Unable to obtain characteristic patient information, such as age and tumor stage. (6) Change in regimen during neoadjuvant therapy; (7) Lost to follow-up patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological complete response rate
Time frame: 1 year
The proportion of patients who achieved pathological complete response after undergoing complete neoadjuvant therapy and subsequent surgery
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jue Wang study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TNBC, Triple Negative Breast Cancer, 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 1 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: opening soon, as of the sponsor's last update on 13 Apr 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.
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 Xiaoming Zha (008613952001278, njzhaxm@njmy.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: 1 year). 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 13 Apr 2026.