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New treatment option for Triple Negative Breast Cancer (TNBC)
Official title QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07342283
What this study is testing
What is Immunotherapy combined with chemotherapy?
Immunotherapy combined with chemotherapy is an investigational medicine, being studied as a potential treatment for triple negative breast cancer (tnbc).
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 is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles).
- 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 and older
You may be able to join if
- Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells...
- Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with...
- Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are...
- Treatment-naïve people;
- Age ≥18 years, both genders eligible;
You likely can't join if
- History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma...
- people who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
- Stage IV metastatic breast cancer;
- Administration of a vaccine within 30 days before the first dose of the study treatment;
- people with severe systemic diseases;
- people with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
See the full eligibility criteria
- Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by...
- Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
- Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
- Treatment-naïve people;
- Age ≥18 years, both genders eligible;
- ECOG performance status 0-1;
- Adequate bone marrow, cardiac, and organ function;
- Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;
- Ability to comprehend and provide written informed consent.
- History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
- people who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
- Stage IV metastatic breast cancer;
- Administration of a vaccine within 30 days before the first dose of the study treatment;
- people with severe systemic diseases;
- people with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
- Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New...
- Lactating women should discontinue breastfeeding during the study;
- people with known allergies to the study drug or any of its excipients;
- Any other condition deemed inappropriate for participation in the study by the investigator. \-
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, 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.