Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for advanced breast cancer: drug combo targets resistant tumors

NCT ID NCT05860465

Disease control Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new oral drug called SPH4336 combined with hormone therapy (letrozole or fulvestrant) in people with a common type of advanced breast cancer (HR-positive, HER2-negative) that has worsened after prior treatment. About 254 participants will receive either the drug or a placebo alongside hormone therapy. The goal is to see if the combination can shrink tumors or delay cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPH4336 tablets (a targeted cancer drug) combined with letrozole or fulvestrant (hormone therapies)
What this could lead to
If successful, this could offer a new treatment option for people with advanced breast cancer whose current therapy has stopped working.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove effective or safe enough for approval. Side effects from the combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 254 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF). 2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1. 3. Life expectancy ≥ 3 months. 4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries/other local therapies. 5. At least one measurable lesion. 6. Laboratory test results meet the relevant requirements for organ function. 7. Subjects who agree to take effective contraceptive measures. Exclusion Criteria: 1. Inflammatory breast cancer. 2. Patients unsuitable for endocrine therapy at the investigator's discretion. 3. History of other malignancies prior to the start of study treatment. 4. Patients with known metastases to central nervous system. 5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF. 6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery. 7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment. 8. Pregnant or lactating women. 9. 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. 10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment. 11. 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. 12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product. 13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment. 14. Presence of uncontrolled infections before the start of study treatment. 15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders. 16. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HR-positive, HER2-negative locally advanced or metastatic breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Cancer Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, He'nan, 455001, China

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, 750003, China

  • Harbin Medical University cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130012, China

  • Liuzhou people's Hospital

    RECRUITING

    Liuzhou, Guangxi, 545026, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, 100730, China

  • Shenzhen Hospital of University of Hong Kong

    RECRUITING

    Shenzhen, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, China

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

    RECRUITING

    Luoyang, He'nan, 450052, China

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

    RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110002, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The second people's hospital of neijiang

    RECRUITING

    Neijiang, Sichuan, 641199, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • Xiangyang Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 441021, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650118, China

  • Zhejiang cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310005, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.