Breast CancerPhase 2NCT07117630
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
A Phase 2 study testing L-Ornithine L-Aspartate, CDK4/6 inhibitor and Fulvestrant in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4/6 inhibitors and Fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer (ABC) who have progressed on prior standard… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- L-Ornithine L-Aspartate, CDK4/6 inhibitor and Fulvestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to Dec 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥ 18 years old.
- Patients with histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER > 10% tumor cell positivity by immunohistochemistry is defined as ER positive, PR positive, PR > 10% tumor cell positivity is defined as PR positive; HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification is defined as HER2 negative).
- Patients with HR+/HER2- advanced breast cancer who have experienced disease progression after receiving systemic therapy including CDK4/6 inhibitors and endocrine therapy.
- Patients whom the investigator judges to be suitable for continued endocrine therapy
- Patients with at least one measurable lesion per RECIST version 1.1 criteria (≥ 20 mm on conventional CT scan, ≥ 10 mm on spiral CT scan, and without prior radiotherapy for measurable lesion).
- Patients whose main organs function normally by meeting the following requirements:
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- Hematology criteria: HB ≥ 90 g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L;
- Blood chemistry criteria: TBIL ≤ 1.5 × ULN (upper limit of normal); ALT and AST ≤ 3 × ULN; if liver metastasis is present, then ALT and AST ≤ 5 × ULN; serum Cr ≤ 1× ULN, endogenous creatinine clearance > 50 mL/min (Cockcroft-Gault formula);
- Patients who have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks prior to the start of the study and have recovered from acute toxicities of prior therapies (if a surgery has been undergone, the wound has completely healed); patients who have no peripheral neuropathy or Grade I peripheral neurotoxicity;
- Patients with ECOG score ≤ 2, and life expectancy ≥ 3 months;
- Female subjects of childbearing potential are required to use a medically acceptable method of contraception during study treatment and for at least 3 months after the last dose of study drug;
- Subjects will be enrolled in this study voluntarily, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.
Who cannot join
- Patients who have received radiotherapy (except for palliative reasons), chemotherapy, immunotherapy, or bisphosphonates (except for bone metastases) within 3 weeks prior to treatment.
- Patients with uncontrolled central nervous system metastases (defined as symptomatic or requiring the use of corticosteroids or mannitol to control symptoms).
- Patients with a history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmia.
- Patients with ongoing ARs ≥ Grade 1 due to prior therapy. Exception to this is alopecia or those that, in the opinion of the investigator, should not be excluded. Such cases should be clearly documented in the investigator's notes.
- Patients who have undergone major surgery (except for minor outpatient surgery, such as placement of vascular access) within 3 weeks of the first course of study treatment.
- Pregnant or lactating patients.
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- Patients with a history of malignancy (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past five years.
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors affecting the taking and absorption of drugs.
- Presence of a third space effusion (such as large pleural fluid and ascites) that cannot be controlled by drainage or other methods.
- Long-term unhealed wounds or incompletely healed fractures.
- Patients with known HBV or HCV infection active phase or hepatitis B DNA ≥ 500, or chronic phase with abnormal liver function.
- Those with allergies, or those who are known to have a history of allergy to the drug components of this study.
- For the Experimental: PARP inhibitor + Fulvestrant + Pioglitazone arm , patients with pathogenic germline BRCA1/2 mutations.
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, 200032
Zhonghua Wang, Professor, 8664175590 ext. 88807, zhonghuawang95@hotmail.com
About this study
This is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4/6 inhibitors and Fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer (ABC) who have progressed on prior standard therapy including CDK4/6 inhibitors and endocrine therapy.
- Conditions
- Breast Cancer
- Being tested
- L-Ornithine L-Aspartate, CDK4/6 inhibitor, Fulvestrant, N-Acetylcysteine (NAC) Treatment, Pioglitazone (PIO)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Ornithine L-AspartateDrug
3g orally three times daily
CDK4/6 inhibitorDrug
at the physician's choice
FulvestrantDrug
500mg IM on Days 1 \& 15 of Cycle 1, then Day 1 of subsequent cycles
N-Acetylcysteine (NAC) TreatmentDrug
600mg orally twice daily
Pioglitazone (PIO)Drug
30mg orally once daily
PARP inhibitorDrug
at the physician's choice
| Study group | Role | What they receive |
|---|---|---|
| CDK4/6 inhibitor + Fulvestrant + L-Ornithine L-Aspartate | Experimental | Not described Receives: Drug: L-Ornithine L-Aspartate; Drug: CDK4/6 inhibitor; Drug: Fulvestrant |
| CDK4/6 inhibitor + Fulvestrant + N-Acetylcysteine | Experimental | Not described Receives: Drug: CDK4/6 inhibitor; Drug: Fulvestrant; Drug: N-Acetylcysteine (NAC) Treatment |
| PARP inhibitor + Fulvestrant + Pioglitazone | Experimental | Not described Receives: Drug: Fulvestrant; Drug: Pioglitazone (PIO); Drug: PARP inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Secondary outcomes (4)
Disease Control Rate (DCR)
Measured: Baseline through end of study, assessed up to 6 months
Progression Free Survival (PFS)
Measured: Randomization to death from any cause, through the end of study, assessed up to 6 months
Safety and treatment-related AEs (assessed by CTCAE v5.0)
The total count and percentage of participants experiencing treatment-related AEs, classified by severity (Grades 1-5) according to CTCAE v5.0
Measured: Randomization to death from any cause, through the end of study, assessed up to 12 months
Biomarker analysis
Pre- and post-treatment samples (tumor tissue, blood, and feces) will be analyzed for blood ammonia levels, ammonia-related genes, cell functions, and microbes to predict therapy response
Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start25 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT07117630
- Sponsor's protocol ID
- SCHBCC-N096
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2025
- Last updated
- 13 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
- ClinicalTrials.gov ID
- NCT07117630
- Acronym / sponsor ID
- SCHBCC-N096
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 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 is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4/6 inhibitors and Fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer (ABC) who have progressed on prior standard therapy including CDK4/6 inhibitors and endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDK4/6 inhibitor + Fulvestrant + L-Ornithine L-Aspartate | Experimental | Drug: L-Ornithine L-Aspartate, Drug: CDK4/6 inhibitor, Drug: Fulvestrant |
| CDK4/6 inhibitor + Fulvestrant + N-Acetylcysteine | Experimental | Drug: CDK4/6 inhibitor, Drug: Fulvestrant, Drug: N-Acetylcysteine (NAC) Treatment |
| PARP inhibitor + Fulvestrant + Pioglitazone | Experimental | Drug: Fulvestrant, Drug: Pioglitazone (PIO), Drug: PARP inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women aged ≥ 18 years old.
- Patients with histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER > 10% tumor cell positivity by immunohistochemistry is defined as ER positive, PR positive, PR > 10% tumor cell positivity is defined as PR positive; HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification is defined as HER2 negative).
- Patients with HR+/HER2- advanced breast cancer who have experienced disease progression after receiving systemic therapy including CDK4/6 inhibitors and endocrine therapy.
- Patients whom the investigator judges to be suitable for continued endocrine therapy
- Patients with at least one measurable lesion per RECIST version 1.1 criteria (≥ 20 mm on conventional CT scan, ≥ 10 mm on spiral CT scan, and without prior radiotherapy for measurable lesion).
Key exclusion criteria (13 listed)
- Patients who have received radiotherapy (except for palliative reasons), chemotherapy, immunotherapy, or bisphosphonates (except for bone metastases) within 3 weeks prior to treatment.
- Patients with uncontrolled central nervous system metastases (defined as symptomatic or requiring the use of corticosteroids or mannitol to control symptoms).
- Patients with a history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmia.
- Patients with ongoing ARs ≥ Grade 1 due to prior therapy. Exception to this is alopecia or those that, in the opinion of the investigator, should not be excluded. Such cases should be clearly documented in the investigator's notes.
- Patients who have undergone major surgery (except for minor outpatient surgery, such as placement of vascular access) within 3 weeks of the first course of study treatment.
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 |
|---|---|---|
| L-Ornithine L-Aspartate3g orally three times daily | Drug | CDK4/6 inhibitor + Fulvestrant + L-Ornithine L-Aspartate |
| CDK4/6 inhibitorat the physician's choice | Drug | CDK4/6 inhibitor + Fulvestrant + L-Ornithine L-Aspartate, CDK4/6 inhibitor + Fulvestrant + N-Acetylcysteine |
| Fulvestrant500mg IM on Days 1 \& 15 of Cycle 1, then Day 1 of subsequent cycles | Drug | CDK4/6 inhibitor + Fulvestrant + L-Ornithine L-Aspartate, CDK4/6 inhibitor + Fulvestrant + N-Acetylcysteine, PARP inhibitor + Fulvestrant + Pioglitazone |
| N-Acetylcysteine (NAC) Treatment600mg orally twice daily | Drug | CDK4/6 inhibitor + Fulvestrant + N-Acetylcysteine |
| Pioglitazone (PIO)30mg orally once daily | Drug | PARP inhibitor + Fulvestrant + Pioglitazone |
| PARP inhibitorat the physician's choice | Drug | PARP inhibitor + Fulvestrant + Pioglitazone |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Baseline through end of study, assessed up to 6 months
Progression Free Survival (PFS)
Time frame: Randomization to death from any cause, through the end of study, assessed up to 6 months
Safety and treatment-related AEs (assessed by CTCAE v5.0)
Time frame: Randomization to death from any cause, through the end of study, assessed up to 12 months
Biomarker analysis
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
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 Jul 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.
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 L-Ornithine L-Aspartate, CDK4/6 inhibitor and Fulvestrant in people with Breast Cancer, 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 12 inclusion and 13 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 13 Jul 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 Zhiming Shao, Professor (08664175590 ext. 88807, zhimin_shao@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months). 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 Jul 2026.