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New treatment option for TNBC, Triple Negative Breast Cancer
Official title A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
ClinicalTrials.gov ID: NCT07178171
What this study is testing
What is QL1706 (bispecific antibody targeting PD-1 and CLTA-4)?
QL1706 (bispecific antibody targeting PD-1 and CLTA-4) is an investigational medicine, being studied as a potential treatment for tnbc, triple negative 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
- Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis. Owing to the absence of actionable receptors on tumor cells, chemotherapy has historically been the mainstay of TNBC treatment.
- Phase 1: an early, usually small safety 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 70, women only
You may be able to join if
- Female patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer.
- Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3.
- Unilateral disease.
- No prior chemotherapy or immunotherapy for invasive breast cancer.
- ECOG performance status of 0-1.
You likely can't join if
- History of invasive malignant tumor within ≤5 years prior to signing the informed consent form, except for adequately treated basal cell or squamous...
- History of autoimmune disease;
- Active hepatitis B or C virus infection, except for hepatitis B virus carriers or patients stabilized after antiviral therapy, who may be enrolled if...
- Presence of any active infection requiring systemic therapy.
- Currently using corticosteroids or immunosuppressive agents.
- Prior treatment with immune checkpoint inhibitors.
See the full eligibility criteria
- Female patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer.
- Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3.
- Unilateral disease.
- No prior chemotherapy or immunotherapy for invasive breast cancer.
- ECOG performance status of 0-1.
- Adequate renal, hepatic, cardiovascular, and bone marrow function.
- The patient voluntarily participates and signs the informed consent form.
- According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients should have measurable tumor lesion.
- Estimated life expectancy ≥6 months
- Female people enrolled must be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device [IUD], oral contraceptives, or condoms) during...
- Able to comply with study and follow-up procedures and willing to adhere to the visit schedule and the prohibitions and restrictions specified in the protocol.
- History of invasive malignant tumor within ≤5 years prior to signing the informed consent form, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
- History of autoimmune disease;
- Active hepatitis B or C virus infection, except for hepatitis B virus carriers or patients stabilized after antiviral therapy, who may be enrolled if HBV DNA titer is ≤500 IU/mL or \<2500 copies/mL. Active hepatitis C...
- Presence of any active infection requiring systemic therapy.
- Currently using corticosteroids or immunosuppressive agents.
- Prior treatment with immune checkpoint inhibitors.
- Presence of psychiatric disorders or other conditions that may affect patient compliance.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding female patients.
- Known allergy to the investigational drugs used in this study or their components.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, 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.