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Locally Advanced or Metastatic Breast CancerPhase 2/3NCT05860465

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

A Phase 2/3 study testing SPH4336 Tablets in people with Locally Advanced or Metastatic Breast Cancer, run by Shanghai Pharmaceuticals Holding Co., Ltd at 22 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
SPH4336 Tablets
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
22 sitesChina
Study dates
8 Sep 2023to 30 Dec 2026
Phase
Phase 2/3
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

  • Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).
  • ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
  • Life expectancy ≥ 3 months.
  • Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies.
  • At least one measurable lesion.
  • Laboratory test results meet the relevant requirements for organ function.
  • Subjects who agree to take effective contraceptive measures.

Who cannot join

  • Inflammatory breast cancer.
  • Patients unsuitable for endocrine therapy at the investigator's discretion.
  • History of other malignancies prior to the start of study treatment.
  • Patients with known metastases to central nervous system.
  • Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.
  • Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.
Show all 16Show fewer
  • Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.
  • Pregnant or lactating women.
  • History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.
  • History of ischemic stroke or severe thromboembolic disease before the start of study treatment.
  • Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA > 2,000 IU/mL or > 104 copies/mL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.
  • History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.
  • Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.
  • Presence of uncontrolled infections before the start of study treatment.
  • Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.
  • Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shusen Wang contact

0086-020-87343811

wangshs@sysucc.org.cn

22 sites in 1 country

China22 sites, 22 recruiting

  • Anyang Cancer Hospital

    Anyang, He'nan, 455001

    Jing Sun

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Chunmei Bai

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

    Jun Qian

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

    Ying Cheng

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Weiwei Huang

    Recruiting

  • Affiliated Cancer Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Shusen Wang, 0086-020-87343811, wangshs@sysucc.org.cn

    Recruiting

  • Zhejiang cancer Hospital

    Hangzhou, Zhejiang, 310005

    Zhanhong Chen

    Recruiting

  • Harbin Medical University cancer Hospital

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Jianyun Nie

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming

    Jinxian Qian

    Recruiting

  • Liuzhou people's Hospital

    Liuzhou, Guangxi, 545026

    Bin Yu

    Recruiting

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

    Luoyang, He'nan, 450052

    Xinshuai Wang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Jifeng Feng

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Yongmei Yin

    Recruiting

  • The second people's hospital of neijiang

    Neijiang, Sichuan, 641199

    Xujuan Wang

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Yue'e Teng

    Recruiting

  • Shenzhen Hospital of University of Hong Kong

    Shenzhen

    Haiman Jing

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Cuizhi Geng

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Yehui Shi

    Recruiting

  • Xiangyang Cancer Hospital

    Wuhan, Hubei, 441021

    Yuehua Wang

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi’an, Shanxi, 710061

    Jin Yang

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

    Xinlan Liu

    Recruiting

Other trials in China

About this study

Official title: A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

Being tested
SPH4336 Tablets, SPH4336 Tablets Placebo
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SPH4336 TabletsDrug

    SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion

  • SPH4336 Tablets PlaceboDrug

    SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion

Study groups in NCT05860465
Study groupRoleWhat they receive
SPH4336 TabletsExperimentalSPH4336 Tablets; Letrozole tablets; Fulvestrant injection
Receives: Drug: SPH4336 Tablets
SPH4336 Tablets PlaceboPlacebo comparatorSPH4336 Tablets Placebo; Letrozole tablets; Fulvestrant injection
Receives: Drug: SPH4336 Tablets Placebo

What is being measured

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

  1. Objective response rate

    tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

    Measured: Approximately 3years

  2. Progression-free survival (PFS)

    from the start date of study treatment to the date of progression disease or death , whichever occurred first.

    Measured: Approximately 3years

Secondary outcomes (6)

  1. Cmax

    PK (Pharmacokinetics) parameters

    Measured: Approximately 3years

  2. Tmax

    PK (Pharmacokinetics) parameters

    Measured: Approximately 3years

  3. Disease control rate (DCR)

    DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease

    Measured: Approximately 3years

  4. Duration of remission (DOR)

    DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause

    Measured: Approximately 3years

  5. Overall Survival (OS)

    Determination of the overall survival times of all patients

    Measured: Approximately 8years

  6. Safety and tolerability of the combination therapy since the start of any study treatment.

    Adverse event type, incidence, duration, correlation with study drug

    Measured: Approximately 3years

Timeline

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

  1. First posted16 May 2023
  2. Study start8 Sep 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05860465
Sponsor's protocol ID
SPH4336-302
Status last verified
Aug 2025
First submitted
8 May 2023
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SPH4336 Tablets in people with Locally Advanced or Metastatic Breast Cancer, run by Shanghai Pharmaceuticals Holding Co., Ltd at 22 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 16 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 combined 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.

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 Shusen Wang (0086-020-87343811, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Approximately 3years). The study lists 2 primary outcomes in all. 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 NCT05860465.

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 14 Jan 2026.

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