Neoadjuvant TherapyPhase 3NCT06913777
Neoadjuvant SNF Precision Therapy Phase III
A Phase 3 study testing Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib and Chemotherapy (wP-EC) in people with Neoadjuvant Therapy, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Neoadjuvant Therapy
- What is being tested?
- Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib and Chemotherapy (wP-EC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 15 Apr 2027
- Phase
- Phase 3
- 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
None listed.
Who cannot join
- Stage IV (metastatic) breast cancer.
- History of invasive breast cancer.
- History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
- Prior systemic therapy for breast cancer (chemotherapy, endocrine therapy, or anti-HER2 therapy), or prior excisional biopsy/radiotherapy of primary breast tumor and/or axillary lymph nodes (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors).
- Other malignancies within the past 5 years (except cured cervical carcinoma in situ or non-melanoma skin cancer).
- Participation in any other investigational drug study within 4 weeks prior to randomization.
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- Peripheral neuropathy ≥ Grade 2 (per NCI-CTCAE v5.0).
- Severe cardiovascular or cerebrovascular diseases within 6 months prior to randomization, including but not limited to:
- Congestive heart failure,
- Unstable angina,
- Severe uncontrolled arrhythmias,
- Clinically significant valvular disease,
- Uncontrolled severe hypertension,
- Myocardial infarction, or
- Cerebrovascular accident.
- Any severe uncontrolled systemic disease that may interfere with the treatment plan, including significant cardiovascular, pulmonary, or metabolic disorders.
- Major surgery within 4 weeks prior to randomization without full recovery, or anticipated need for major surgery during the study treatment.
- Systemic corticosteroid use (>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to the first dose of study drug (except for prophylactic anti-allergy or antiemetic purposes).
- Inhaled/topical steroids or physiologic steroid replacement doses (≤10 mg/day prednisone equivalent) are permitted in the absence of active autoimmune disease.
- Administration of anti-cancer vaccines or live vaccines within 4 weeks prior to the first dose of study drug.
- Active autoimmune disease or history of autoimmune disorders (e.g., interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyper/hypothyroidism), EXCEPT:
- Vitiligo,
- Childhood asthma/allergies resolved without intervention in adulthood,
- Stable hypothyroidism on hormone replacement,
- Type 1 diabetes on stable insulin therapy.
- Immunodeficiency (e.g., HIV-positive, congenital/acquired immune deficiency) or history of organ/allogeneic bone marrow transplantation.
- History of interstitial lung disease (except radiation pneumonitis without steroid treatment) or non-infectious pneumonitis.
- Active liver disease, including:
- Hepatitis B (HBsAg-positive with HBV-DNA ≥1000 IU/mL),
- Hepatitis C (HCV-Ab-positive with detectable HCV-RNA), or
- Autoimmune hepatitis.
- Pregnancy or lactation.
- Known hypersensitivity to the study drug(s), its excipients, or severe allergic reactions to monoclonal antibodies.
- History of substance abuse, alcoholism, or drug addiction.
- Uncontrolled psychiatric/neurological disorders (e.g., epilepsy, dementia) or poor compliance.
- Any other condition that may increase study risk, interfere with treatment/outcomes, or render the patient unsuitable for participation per investigator's judgment.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, zhi_ming_shao@163.com
About this study
Official title: An Open-Label, Multicenter, Randomized Controlled Phase III Clinical Study of Neoadjuvant Chemotherapy Based on SNF Classification With or Without Precision Medicine Agents for Early-Stage or Locally Advanced HR+/HER2- Breast Cancer
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.
- Conditions
- Neoadjuvant Therapy
- Being tested
- Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib, Chemotherapy (wP-EC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinibDrug
The backbone is chemotherapy which will be used in the control group. The precision group will add targeted therapy agents which were determined according to SNF classification: the SNF2 subtype add adebrelimab combined with famitinib, the SNF3 subtype receives fluzoparib, and the SNF4 subtype receives apatinib.
Chemotherapy (wP-EC)Drug
Chemotherapy : weely nab-P * 12- EC * 4
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | chemotherapy (wP-EC） Receives: Drug: Chemotherapy (wP-EC) |
| Precision group | Experimental | chemotherapy + target therapy Receives: Drug: Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib; Drug: Chemotherapy (wP-EC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery)
pCR rate after neoadjuvant treatment, defined as the proportion of participants who have no evidence by H\&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by investigator assessment following completion of neoadjuvant therapy.
Measured: Up to approximately 1 year
Secondary outcomes (5)
Event-free survival (EFS) rate at 12, 24, 36-month
EFS is defined as time from date of randomisation until disease progression precluding initial surgery, invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Measured: Up to approximately 3 years
Invasive disease-free survival (IDFS) rate at 12, 24, 36-month
IDFS is defined as time from surgery until invasive disease recurrence (local, regional, distant, or contralateral), or death from any cause.
Measured: Up to approximately 3 years
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Approximately 5 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Measured: Approximately 1 year
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.
Measured: Up to approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start8 Apr 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- More trials run by Fudan 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913777
- Sponsor's protocol ID
- SCHBCC-N090
- Status last verified
- Jun 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized Controlled Phase III Clinical Study of Neoadjuvant Chemotherapy Based on SNF Classification With or Without Precision Medicine Agents for Early-Stage or Locally Advanced HR+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT06913777
- Acronym / sponsor ID
- SCHBCC-N090
- Conditions
- Neoadjuvant Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 6 Apr 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 study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial designed to compare the efficacy and safety of neoadjuvant chemotherapy based on SNF classification with or without precision medicine agents in previously untreated patients with early-stage or locally advanced HR+/HER2- breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Chemotherapy (wP-EC)chemotherapy (wP-EC） |
| Precision group | Experimental | Drug: Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib, Drug: Chemotherapy (wP-EC)chemotherapy + target therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (36 listed)
- Stage IV (metastatic) breast cancer.
- History of invasive breast cancer.
- History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).
- Prior systemic therapy for breast cancer (chemotherapy, endocrine therapy, or anti-HER2 therapy), or prior excisional biopsy/radiotherapy of primary breast tumor and/or axillary lymph nodes (excluding diagnostic biopsy for primary breast cancer or surgery for benign breast tumors).
- Other malignancies within the past 5 years (except cured cervical carcinoma in situ or non-melanoma skin cancer).
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 |
|---|---|---|
| Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinibThe backbone is chemotherapy which will be used in the control group. The precision group will add targeted therapy agents which were determined according to SNF classification: the SNF2 subtype add adebrelimab combined with famitinib, the SNF3 subtype receives fluzoparib, and the SNF4 subtype receives apatinib. | Drug | Precision group |
| Chemotherapy (wP-EC)Chemotherapy : weely nab-P * 12- EC * 4 | Drug | Control, Precision group |
Primary outcome
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery)
Time frame: Up to approximately 1 year
pCR rate after neoadjuvant treatment, defined as the proportion of participants who have no evidence by H\&E staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by investigator assessment following completion of neoadjuvant therapy.
5 secondary outcomes
Event-free survival (EFS) rate at 12, 24, 36-month
Time frame: Up to approximately 3 years
Invasive disease-free survival (IDFS) rate at 12, 24, 36-month
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Approximately 5 years
Objective Response Rate (ORR)
Time frame: Approximately 1 year
Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).
Time frame: Up to approximately 1.5 years
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 6 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Targeted therapy agents: SNF2 -adebrelimab + famitinib; SNF3 -fluzoparib; SNF4 -apatinib and Chemotherapy (wP-EC) in people with Neoadjuvant Therapy, run by Fudan 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 0 inclusion and 36 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 6 Jun 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zhimin Shao, MD, PhD (+86-021-64175590, zhi_ming_shao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 ((i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery) (time frame: Up to approximately 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 6 Jun 2025.