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Breast CancerPhase 3NCT05433480

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

A Phase 3 study testing BPI-16350 and Fulvestrant in people with Breast Cancer, run by Betta Pharmaceuticals Co., Ltd. at 64 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
BPI-16350 and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
64 sitesChina
Study dates
25 May 2022to 31 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer
  • One previous line of chemotherapy for advanced/metastatic disease is allowed
  • Disease Progression following endocrine therapy
  • Have postmenopausal status
  • Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: measurable disease or nonmeasurable bone-only disease
  • ECOG: 0~1
  • Adequate organ function

Who cannot join

  • Previous treatment with cytotoxic drugs within 4 weeks before enrollment
  • Previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor TKI within 2 weeks before enrollment
  • Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant
  • HER2 positive
  • Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc
  • Pregnancy or lactation
  • Other conditions considered not appropriate to participate in this trial by the investigators

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

China64 sites

  • Anyang Cancer Hospital

    Anyang, Henan, 455001

  • The First Medical Center of the PLA General Hospital

    Beijing, Beijing Municipality, 100039

  • The Seventh Medical Center of the PLA General Hospital

    Beijing, Beijing Municipality, 100039

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233099

  • Cangzhou Hospital of Integrated TCM-WM·Hebei

    Cangzhou, Hebei, 061012

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • The First People's Hospital Of Changde City

    Changde, Hunan, 415003

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 067020

  • Sichuan Cancer Hospital&Institute

    Chengdu, Sichuan, 610042

  • The Sixth People's Hospital of Chengdu

    Chengdu, Sichuan, 610051

  • Chenzhou First People's Hospital

    Chenzhou, Hunan, 423099

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 400030

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi, 100044

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Sun Yat-Sen University Cancer Hospital

    Guangzhou, Guangdong, 510060

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230002

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The First Affiliated Hospital of Nanhua University

    Hengyang, Hunan, 421001

  • Inner Mongolia People's Hospital

    Hohhot, Neimenggu, 421001

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272007

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730013

  • Linyi Cancer Hospital

    Linyi, Shandong, 276002

  • Loudi Central Hospital

    Loudi, Hunan, 417099

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 450052

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330008

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • The first Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 473007

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • Shaoyang Central Hospital

    Shaoyang, Hunan, 422000

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 100012

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Liaoning Cancer Hospital ＆ Institute

    Shenyang, Liaoning, 110801

  • Jilin Hospital of Chinese Literature

    Siping, Jilin, 132011

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Tangshan People's Hospital

    Tangshan, Hebei, 063001

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300181

  • Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Weifang People's Hospital

    Weifang, Shangdong, 261000

  • Weihai Municipal Hospital

    Weihai, Shandong, 264299

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Fifth Hospital in WuHan

    Wuhan, Hubei, 430050

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xiamen University

    Ximen, Fujian, 361003

  • Xingtai People's Hospital

    Xingtai, Hebei, 054001

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • Yichang Central People's Hospital

    Yichang, Hubei, 443008

  • Yongzhou Central Hospital

    Yongzhou, Hunan, 425002

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Fulvestrant Plus BPI-16350 or Plus Placebo in Patients With HR+, HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer With Disease Progression Following Endocrine Therapy

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.

Conditions
Breast Cancer
Being tested
BPI-16350, placebo, Fulvestrant
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPI-16350Drug

    BPI-16350 400 mg, orally once daily

  • placeboDrug

    Placebo 400 mg, orally once daily

  • FulvestrantDrug

    Fulvestrant 500 mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease

Study groups in NCT05433480
Study groupRoleWhat they receive
experimental groupExperimentalIntervention Drug: BPI-16350, Fulvestrant
Receives: Drug: BPI-16350; Drug: Fulvestrant
control groupPlacebo comparatorIntervention Drug: Placebo, Fulvestrant
Receives: Drug: placebo; Drug: Fulvestrant

What is being measured

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

  1. Investigator-assessed PFS

    The PFS time is measured from the date of randomization to the date of objective progression or the date of death due to any cause, whichever is earlier.

    Measured: up to 3 years

Secondary outcomes (9)

  1. IREC-assessed PFS

    The PFS time is measured from the date of randomization to the date of objective progression or the date of death due to any cause, whichever is earlier.

    Measured: up to 3 years

  2. ORR

    The proportion of patients with CR or PR according to RECIST v1.1

    Measured: up to 3 years

  3. DCR

    The proportion of patients with CR, PR, or SD according to RECIST v1.1

    Measured: up to 3 years

  4. DOR

    The time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier

    Measured: up to 3 years

  5. CBR

    The proportion of patients with CR, PR, or SD ≥6 months according to RECIST v1.1

    Measured: up to 3 years

  6. OS

    The time from the date of randomization to the date of death from any cause

    Measured: up to 5 years

  7. AEs and SAEs

    Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0

    Measured: up to 3 years

  8. EORTC QLQ-C30

    Changes in scores from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Measured: up to 5 years

  9. Evaluate the pharmacokinetics of BPI-16350

    Based on blood plasma concentration.

    Measured: Up to 3 cycles(each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start25 May 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Jul 2025 (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
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05433480
Sponsor's protocol ID
BTP-66732
Status last verified
May 2023
First submitted
16 Jun 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tao Z, Zhang J, Zheng Q, Wang Y, Cai L, Xu H, Xu X, Kong X, Ding S, Hao C, Wang H, Zong H, Jin X, Wang X, Li Y, Yang X, Li W, Du X, Chen H, Wu P, Li P, Mao L, Ding L, Hu X, Wang S. Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1055-1063. doi: 10.1001/jamaoncol.2025.2092.

    PubMed 40742733

  • Zhang J, Liu R, Gao S, Chen W, Han X, Wang Z, Zhou H, Wang Y, Chen J, Ma Y, Liu K, Shen Z, Ding L, Li P, Hu X. A phase I dose-escalation and dose-expansion study of tibremciclib, a novel CDK4/6 inhibitor, monotherapy and in combination with fulvestrant in HR-positive/HER2-negative advanced breast cancer. ESMO Open. 2025 Jun;10(6):105121. doi: 10.1016/j.esmoop.2025.105121. Epub 2025 May 21.

    PubMed 40403388

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BPI-16350 and Fulvestrant in people with Breast Cancer, run by Betta Pharmaceuticals Co., Ltd. at 64 sites 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites 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?

Results are not available in the source record.

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 PFS (time frame: up to 3 years). 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 NCT05433480, which also lists 2 linked publications.

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 27 Jul 2023.

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