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Compares treatment options for Early-stage or Locally Advanced HER2-positive Breast Cancer
Official title A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT07196774
What this study is testing
What is SHR-A1811 for Injection?
SHR-A1811 for Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for early-stage or locally advanced her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Females treated for the first time, 18-75 years old;
- ECOG score 0-1;
- Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
- Results of laboratory tests meet the enrollment requirements;
- Pregnancy test result must be negative and must agree to contraception;
You likely can't join if
- Confirmed HER2 negative;
- Has tumor-related medical history or treatment history;
- Has severe combined disease/medical history and treatment history;
- Has received treatment with systemic immunostimulants or immunosuppressants;
- Be allergic to the test drug;
- Participate in other clinical trials simultaneously;
See the full eligibility criteria
- Females treated for the first time, 18-75 years old;
- ECOG score 0-1;
- Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
- Results of laboratory tests meet the enrollment requirements;
- Pregnancy test result must be negative and must agree to contraception;
- Has signed the informed consent form.
- Confirmed HER2 negative;
- Has tumor-related medical history or treatment history;
- Has severe combined disease/medical history and treatment history;
- Has received treatment with systemic immunostimulants or immunosuppressants;
- Be allergic to the test drug;
- Participate in other clinical trials simultaneously;
- Has received vaccine within 30 days before the first dose;
- Has received allograft bone marrow transplantation;
- Has given birth within one year or is breastfeeding;
- Has history of psychological drug abuse, alcoholism or drug use.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.