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New treatment option for Unresectable Locally Recurrent Breast Cancer
Official title A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07497386
What this study is testing
What is Trastuzumab Rezetecan for Injection?
Trastuzumab Rezetecan for Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for unresectable locally recurrent 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
- The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.
- Phase 2: a mid-size study of how well it works
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
- Female aged 18 to 75 years (inclusive).
- Unresectable locally recurrent or metastatic breast cancer.
- Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of...
- Documented radiological disease progression (during or after the most recent therapy).
- ECOG performance status of 0 or 1.
You likely can't join if
- Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.
- Patients with only skin or brain lesions as target lesions.
- History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.
- Prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before the first dose; prior endocrine therapy...
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 2 weeks before the first dose for therapeutic intent.
See the full eligibility criteria
- Female aged 18 to 75 years (inclusive).
- Unresectable locally recurrent or metastatic breast cancer.
- Prior therapy must meet the following: No prior chemotherapy for recurrent/metastatic disease. Must have received at least one prior line of endocrine therapy for recurrent/metastatic disease with disease progression...
- Documented radiological disease progression (during or after the most recent therapy).
- ECOG performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- At least one extracranial measurable lesion as a target lesion according to RECIST v1.1 criteria.
- Adequate function of major organs.
- Pregnancy and contraception: Women of childbearing potential (WOCBP) must agree to use highly effective contraception from study screening until 7 months after the last dose of study drug and agree not to breastfeed...
- The patient voluntarily participates in this study, signs the informed consent form, has good compliance, and is willing to cooperate with visits and study-related procedures.
- Presence of leptomeningeal metastasis/carcinomatous meningitis, spinal cord compression, or active central nervous system metastases.
- Patients with only skin or brain lesions as target lesions.
- History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Presence of carcinomatous lymphangitis, or third-space fluid accumulation that cannot be controlled by methods such as drainage.
- Prior surgery, chemotherapy, immunotherapy, or macromolecular targeted therapy within 4 weeks before the first dose; prior endocrine therapy, chemotherapy with 5-FU analogs, or radiotherapy within 2 weeks before the...
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 2 weeks before the first dose for therapeutic intent.
- History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Clinically significant cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure, etc.; clinically significant supraventricular or ventricular arrhythmia requiring treatment or...
- Participants with known or suspected interstitial lung disease; other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect...
- Known hereditary or acquired bleeding tendency.
- Active hepatitis B, hepatitis C, or cirrhosis; or severe infection requiring control with antibiotics, antivirals, or antifungals.
- Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 (according to NCI-CTCAE v5.0).
- Any other severe physical or mental illness or laboratory abnormality that may increase the risk associated with study participation, interfere with study results, or any other condition for which the investigator...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.