Advanced Breast CancerPhase 3NCT05257395
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
A Phase 3 study testing XZP-3287+ Letrozole/Anastrozole in people with Advanced Breast Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- XZP-3287+ Letrozole/Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 397 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2022to 5 Sep 2030
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤75 years old;
- Patient is in the menopausal state；
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic breast cancer, which was pathologically confirmed to be HR-positive and HER2-negative;
- Evidence of locally advanced, recurrent, or metastatic disease that is not amenable to curative surgical resection or radiation therapy and is not clinically amenable to chemotherapy;
- No prior systemic anticancer therapy for locally advanced, recurrent, or metastatic disease;
- At least one measurable lesion (based on RECIST v1.1) or only bone metastases;
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- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Adequate organ and marrow function;
- Patient of childbearing age must undergo a serum pregnancy test within 7 days before randomization, and the result is negative; patient is willing to use a medically approved high-efficiency contraceptive method during the study period and within 6 months after the last study drug treatment;
- Patient with acute toxic reactions caused by previous anti-tumor treatments or surgical operations were alleviated to grade 0 to 1 (NCI-CTCAE v5.0), or to the level specified by the enrollment criteria;
- Patient has signed informed consent before any trial related activities.
Who cannot join
- Patients with disease recurrence or metastasis at or within 12 months after previous neoadjuvant or adjuvant therapy with endocrine drugs;
- Patient with visceral crisis or brain metastases, except for patient with stable brain metastases;
- Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;
- Patient who received prior treatment with mTOR inhibitors or CDK4/6 inhibitors ;
- Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment；
- Patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer;
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- Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;
- Initiation of bisphosphonates or RANKL inhibitors within 7 days before enrollment, and subjects who have initiated treatment > 7 days before enrollment should not change the method of use;
- Any other malignant tumor has been diagnosed within 5 years before randomization;
- Patient is in the active stage of HBV, HCV or co-infected with HBV, HCV, or Patient with positive HIV antibody;
- Patient with severe infection within 4 weeks before enrollment, or unexplained fever> 38.3℃ during screening/before enrollment;
- Patient with heart function impaired or clinically significant heart disease within 6 months before enrollment;
- Cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; pulmonary embolism;
- Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug;
- Patient with a known hypersensitivity to any of the excipients in this study;
- A prior history of autologous or allogeneic hematopoietic stem cell transplantation;
- A prior history of psychotropic drug abuse or drug use;
- Nursing Mothers;
- The researchers considered that there were some cases that were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
About this study
Official title: A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.
- Conditions
- Advanced Breast Cancer
- Being tested
- XZP-3287+ Letrozole/Anastrozole, Placebo + Letrozole/Anastrozole
- Keywords
- XZP-3287, HR positive Her2 negative recurrent/metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XZP-3287+ Letrozole/AnastrozoleDrug
XZP-3287 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle
Placebo + Letrozole/AnastrozoleDrug
Placebo 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| XZP-3287+ Letrozole/Anastrozole | Experimental | Not described Receives: Drug: XZP-3287+ Letrozole/Anastrozole |
| Placebo + Letrozole/Anastrozole | Placebo comparator | Not described Receives: Drug: Placebo + Letrozole/Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed progression free survival (PFS)
Measured: Up to approximately 24 months
Secondary outcomes (12)
BICR-assessed progression free survival (PFS)
Measured: Up to approximately 24 months
Overall survival (OS)
Measured: Up to approximately 5 years
Overall survival rate(OSR)
Measured: Up to approximately 5 years
Objective response rate (ORR)
Measured: Up to approximately 24 months
Duration of response (DoR)
Measured: Up to approximately 24 months
Disease control rate (DCR)
Measured: Up to approximately 24 months
Clinical benefit rate (CBR)
Measured: Up to approximately 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Up to approximately 24 months
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Measured: Up to approximately 24 months
Maximum Plasma Concentration [Cmax]
Measured: Up to approximately 4 months
Time to Maximum Plasma Concentration [Tmax]
Measured: Up to approximately 4 months
Area under the time-concentration Curve [AUC]
Measured: Up to approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start14 Mar 2022
- Primary completion5 Dec 2025 (estimated)
- Study completion5 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingyuan Zhang, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257395
- Sponsor's protocol ID
- XZP-3287-3002
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting the findings of this trial, including source data, cannot be made available openly owing to their proprietary nature and that the BRIGHT-3 study is still ongoing and blinded.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05257395
- Acronym / sponsor ID
- XZP-3287-3002
- Conditions
- Advanced Breast Cancer
- Keywords
- XZP-3287, HR positive Her2 negative recurrent/metastatic breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 5 Sep 2030 (estimated)
- First posted
- 25 Feb 2022 (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 Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XZP-3287+ Letrozole/Anastrozole | Experimental | Drug: XZP-3287+ Letrozole/Anastrozole |
| Placebo + Letrozole/Anastrozole | Placebo comparator | Drug: Placebo + Letrozole/Anastrozole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female patients aged ≥18 years and ≤75 years old;
- Patient is in the menopausal state；
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic breast cancer, which was pathologically confirmed to be HR-positive and HER2-negative;
- Evidence of locally advanced, recurrent, or metastatic disease that is not amenable to curative surgical resection or radiation therapy and is not clinically amenable to chemotherapy;
- No prior systemic anticancer therapy for locally advanced, recurrent, or metastatic disease;
Key exclusion criteria (19 listed)
- Patients with disease recurrence or metastasis at or within 12 months after previous neoadjuvant or adjuvant therapy with endocrine drugs;
- Patient with visceral crisis or brain metastases, except for patient with stable brain metastases;
- Patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment;
- Patient who received prior treatment with mTOR inhibitors or CDK4/6 inhibitors ;
- Participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment；
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 |
|---|---|---|
| XZP-3287+ Letrozole/AnastrozoleXZP-3287 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle | Drug | XZP-3287+ Letrozole/Anastrozole |
| Placebo + Letrozole/AnastrozolePlacebo 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle | Drug | Placebo + Letrozole/Anastrozole |
Primary outcome
Investigator-assessed progression free survival (PFS)
Time frame: Up to approximately 24 months
12 secondary outcomes
BICR-assessed progression free survival (PFS)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 5 years
Overall survival rate(OSR)
Time frame: Up to approximately 5 years
Objective response rate (ORR)
Time frame: Up to approximately 24 months
Duration of response (DoR)
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
Clinical benefit rate (CBR)
Time frame: Up to approximately 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 24 months
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 24 months
Maximum Plasma Concentration [Cmax]
Time frame: Up to approximately 4 months
Time to Maximum Plasma Concentration [Tmax]
Time frame: Up to approximately 4 months
Area under the time-concentration Curve [AUC]
Time frame: Up to approximately 4 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 17 Jul 2025.
- Individual participant dataSharing planned: No. The data supporting the findings of this trial, including source data, cannot be made available openly owing to their proprietary nature and that the BRIGHT-3 study is still ongoing and blinded.
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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. This study is not recruiting at the moment.
Qingyuan Zhang principal investigator
The Second Affiliated Hospital of Harbin Medical University
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 XZP-3287+ Letrozole/Anastrozole in people with Advanced Breast Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. 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 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed progression free survival (PFS) (time frame: Up to approximately 24 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 17 Jul 2025.