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Breast CancerPhase 1/2NCT06788197

A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients

A Phase 1/2 study testing SHR-A1811+ Fulvestrant and SHR-A1811+ Fulvestrant+HS-10352 in people with Breast Cancer and Locally Advanced or Metastatic Breast Cancer, run by Henan Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
SHR-A1811+ Fulvestrant and SHR-A1811+ Fulvestrant+HS-10352
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
Mar 2025to 31 Mar 2029
Phase
Phase 1/2
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;
  • ECOG Performance Status of 0 -2;
  • Locally advanced/metastatic breast cancer not amenable to curative therapy
  • Disease progression during treatment or within 12 months of completing adjuvant therapy ;
  • No prior anti-cancer systemic therapy has been administered;
  • Fasting blood glucose < 126 mg/dL, and HbA1C < 6.0%;
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  • Life expectancy of ≥3 months;
  • Patients have at least one target lesion according to RECEST 1.1;
  • Adequate function of major organs;
  • Female patients who are either premenopausal or have not undergone surgical sterilization: during the treatment period and for at least 7 months after the final dose of study medication, agree to abstain from sexual activity or utilize effective contraceptive methods.
  • Sign Informed Consent Form.

Who cannot join

  • Breast cancer that has not been histologically confirmed;
  • Inflammatory breast cancer;
  • Participants ineligible for endocrine therapy due to any disease burden, as judged by the investigator;
  • Meningeal metastasis or active parenchymal brain metastasis;
  • Presence of diabetes symptoms, history of primary diabetes, gestational diabetes, steroid-induced diabetes, or other secondary diabetes;
  • Prior anti-cancer systemic therapy has been administered;
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  • Use of investigational drugs within 4 weeks；
  • Received immunotherapy, macromolecular targeted therapy, or other antitumor biologics within 4 weeks; or received endocrine therapy, chemotherapy, small molecule targeted drug therapy, or traditional Chinese medicine treatment with antitumor indications within 2 weeks;
  • Received radical radiotherapy within 4 weeks, or received palliative radiotherapy within 2 weeks;
  • Previously received antitumor treatment or radiotherapy for any malignancy, excluding malignancies such as cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;
  • A history of other malignancies within the past 5 years, excluding cured cases of skin basal cell carcinoma and cervical carcinoma in situ;
  • Prior anti-tumor treatment toxicities have not yet recovered to NCI CTCAE V5.0 grade ≤1 or baseline levels;
  • A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Interstitial pneumonia/interstitial lung disease, or presence of moderate to severe pulmonary disease that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first administration of the study drug, as well as any autoimmune, connective tissue, or inflammatory diseases involving the lungs, or a history of total pulmonary resection surgery
  • Presence of active hepatitis B, hepatitis C, liver cirrhosis, or severe infections requiring control with antibiotics, antiviral drugs, or antifungal medications;
  • History of hereditary or acquired bleeding and thrombotic tendencies (such as haemophilia, coagulation disorders, etc.);
  • Inability to swallow, intestinal obstruction, or the presence of other factors affecting drug intake and absorption;
  • Patients with known allergies or contraindications to the study drug and its excipient components;
  • Female patients who are pregnant or lactating, those of reproductive potential with a positive baseline pregnancy test, or those of reproductive age who are unwilling to use effective contraceptive measures throughout the entire study period;
  • According to the investigator's judgment, patients with severe concomitant diseases that pose a risk to their safety or prevent them from completing the study, a history of definite neurological or psychiatric disorders, including epilepsy or dementia, or any other condition deemed by the investigator to make the patient unsuitable for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhenzhen Liu, MD contact

86-13603862755

liuzhenzhen73@126.com

Xiaosan Zhang, MD contact

86-15638167115

zxs_8112@126.com

About this study

Official title: A Phase Ib/II Study of SHR-A1811 and Fulvestrant in Combination With or Without HS-10352 in Locally Advanced or Metastatic Breast Cancer Patients Who Progressed After Adjuvant Therapy

This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.

Read the detailed description

This study plans to enroll breast cancer patients whose disease progressed during treatment or within 12 months of completing adjuvant therapy and who have not received prior systemic therapy. SHR-A1811 + fulvestrant group will receive treatment with SHR-A1811 and fulvestrant. HS-10352 group will receive treatment with SHR-A1811, fulvestrant, and HS-10352. Treatment will continue until disease progression or the occurrence of intolerable toxicity.

Being tested
SHR-A1811+ Fulvestrant, SHR-A1811+ Fulvestrant+HS-10352
Keywords
Breast Cancer, SHR-A1811, HS-10352
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SHR-A1811+ FulvestrantDrug

    SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular

  • SHR-A1811+ Fulvestrant+HS-10352Drug

    SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular ； HS-10351 is administered orally

Study groups in NCT06788197
Study groupRoleWhat they receive
SHR-A1811 + fulvestrant groupExperimentalSubjects will receive SHR-A1811 combined with fulvestrant therapy.
Receives: Drug: SHR-A1811+ Fulvestrant
HS-10352 groupExperimentalSubjects will receive SHR-A1811 combined with Fulvestrant and HS-10352 therapy.
Receives: Drug: SHR-A1811+ Fulvestrant+HS-10352

What is being measured

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

  1. Objective Response Rate (ORR) according to RECIST1.1 （SHR-A1811+fulvestrant group and HS-10352 group (Phase II)）

    ORR defined as the proportion of patients with the best overall response of complete response or partial response，as determined by the investigator according to RECIST v1.1

    Measured: Up to approximately 4 years

  2. Recommended Phase 2 dose (RP2D) (HS-10352 group (Phase Ib))

    Measured: From the first dose to the last dose of the first cycle defined as 28 days

Secondary outcomes (6)

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) （SHR-A1811 + fulvestrant group and HS-10352 group (Phase II)）

    Evaluate the incidence and severity of adverse events according to CTCAE 5.0

    Measured: Up to approximately 4 years

  2. Objective Response Rate (ORR) according to RECIST1.1 （HS-10352 group(Phase Ib)）

    ORR defined as the proportion of patients with the best overall response of complete response or partial response，as determined by the investigator according to RECIST v1.1

    Measured: Up to approximately 4 years

  3. Progression-Free Survival (PFS)（SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

    PFS is defined as the time from the first therapeutic dose to death or disease progression

    Measured: Up to 4 years

  4. Overall Survival (OS) （SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

    OS is defined as the time from the first therapeutic dose to death from any cause

    Measured: Up to 4 years

  5. Clinical Benefit Rate (CBR) （CR+ PR+ SD≥24weeks）（SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

    CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1

    Measured: Up to 4 years

  6. Duration of Response (DOR) （SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

    DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first)

    Measured: Up to 4 years

Timeline

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

  1. First posted23 Jan 2025
  2. Study startMar 2025 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
SHR-A1811 + fulvestrant group: SHR-A1811+fulvestrant ； HS-10352 group: SHR-A1811+Fulvestrant+HS-10352
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06788197
Sponsor's protocol ID
2024-528
Status last verified
Mar 2025
First submitted
21 Jan 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A1811+ Fulvestrant and SHR-A1811+ Fulvestrant+HS-10352 in people with Breast Cancer and Locally Advanced or Metastatic Breast Cancer, run by Henan Cancer Hospital.

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 20 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Zhenzhen Liu, MD (86-13603862755, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) according to RECIST1.1 （SHR-A1811+fulvestrant group and HS-10352 group (Phase II)） (time frame: Up to approximately 4 years). 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 NCT06788197.

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 26 Mar 2025.

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