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Advanced Breast CancerPhase 3NCT05077449

A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

A Phase 3 study testing XZP-3287+Fulvestrant in people with Advanced Breast Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study. 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+Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteChina
Study dates
16 Nov 2021to Nov 2029
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；
  • Pathologically-confirmed HR positive and Her2 negative Breast Cancer;
  • Locally advanced stage, recurrence or metastasis breast cancer; 4.1 Disease progression after previous endocrine therapy； 4.2 One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy;
  • At least one measurable lesion (based on RECIST v1.1) or only bone metastases;
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
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  • Adequate organ and marrow function;
  • Patient of childbearing age must undergo a serum pregnancy test within 14 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

  • Patient with visceral crisis, inflammatory breast cancer, 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, CDK4/6 inhibitors or fulvestrant;
  • 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;
  • Patient used CYP3A4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer;
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  • Patient who used bisphosphonates or RANKL inhibitors within 7 days before enrollment, patient who have started treatment during the study should not change the method of use;
  • Any other malignant tumor has been diagnosed within 3 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> 38.5℃ 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; symptomatic 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;
  • Pregnant or breastfeeding;
  • 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

  • Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100025

Other trials in China

About this study

Official title: A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.

Being tested
XZP-3287+Fulvestrant, Placebo + Fulvestrant
Keywords
XZP-3287, HR positive and 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+FulvestrantDrug

    XZP-3287 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease

  • Placebo + FulvestrantDrug

    Placebo 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease

Study groups in NCT05077449
Study groupRoleWhat they receive
XZP-3287+FulvestrantExperimentalNot described
Receives: Drug: XZP-3287+Fulvestrant
Placebo + FulvestrantPlacebo comparatorNot described
Receives: Drug: Placebo + Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed progression free survival (PFS)

    An interim analysis will be performed in this study. The primary endpoint of the study is PFS. An interim analysis is scheduled upon the collection of 70%(approximately 125) PFS events, and the final PFS analysis will be conducted after 178 PFS events have been collected.

    Measured: Up to approximately 24 months

Secondary outcomes (12)

  1. BICR-assessed progression free survival (PFS)

    Measured: Up to approximately 24 months

  2. Overall survival (OS)

    Measured: Up to approximately 5 years

  3. Overall survival rate(OSR)

    Measured: Up to approximately 5 years

  4. Objective response rate (ORR)

    Measured: Up to approximately 24 months

  5. Duration of response (DoR)

    Measured: Up to approximately 24 months

  6. Disease control rate (DCR)

    Measured: Up to approximately 24 months

  7. Clinical benefit rate (CBR)

    Measured: Up to approximately 24 months

  8. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Up to approximately 24 months

  9. Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0

    Measured: Up to approximately 24 months

  10. Maximum Plasma Concentration [Cmax]

    Measured: Up to approximately 4 months

  11. Time to Maximum Plasma Concentration [Tmax]

    Measured: Up to approximately 4 months

  12. 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.

  1. First posted14 Oct 2021
  2. Study start16 Nov 2021
  3. Primary completion22 Feb 2024
  4. Study completionNov 2029 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077449
Sponsor's protocol ID
XZP-3287-3001
Status last verified
May 2024
First submitted
18 Sep 2021
Last updated
24 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang J, Zhang Q, Li H, Tong Z, Ouyang Q, Li H, Teng Y, Wang B, Sun T, Wang J, Li W, Niu Z, Li H, Gong C, Wang S, Wang X, Wu X, Liu N, Yu G, Hu Y, Wang Q, Duan X, Yang F, Wang L, Xu B. Bireociclib Plus Fulvestrant in Advanced Breast Cancer After Endocrine Progression: The BRIGHT-2 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 May 1;12(5):488-496. doi: 10.1001/jamaoncol.2026.0318.

    PubMed 41854603

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XZP-3287+Fulvestrant 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 10 inclusion and 18 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 24 May 2024. 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?

On the ClinicalTrials.gov record for NCT05077449, which also lists 1 linked publication.

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 24 May 2024.

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