Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or… (NCT07246317) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer
China188 participantsStarted 2025-12-15
Plain-language summary
This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent and compliant.
. Age 18-70 years.
. ECOG PS 0-1; life expectancy \>6 months.
. Histologically/cytologically confirmed primary breast cancer.
. Primary tumor \>2cm (by local standard assessment) or node-positive disease.
. AJCC 8th edition Stage II-IIIC (T2-T4 any N, or any T N1-3 M0) unilateral invasive breast cancer.
. Confirmed HER2-positive (IHC 3+ or ISH positive). Note: Patients with HER2-negative primary tumor but HER2-positive nodes are eligible.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Timeframe: Up to approximately 16-18weeks
Trial details
NCT IDNCT07246317
SponsorTianjin Medical University Cancer Institute and Hospital
. Stage IV metastatic breast cancer or patients deemed ineligible for curative surgery after neoadjuvant therapy.
. Inflammatory breast cancer.
. Other malignancies within 3 years, except: those treated with surgery alone and disease-free for 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder cancer \[Ta, Tis, T1\].
. Prior anti-tumor therapy (chemotherapy, endocrine, anti-HER2) or breast surgery for breast cancer within 3 years (excluding diagnostic biopsy).
. Major surgery or significant traumatic injury within 28 days before treatment (excluding diagnostic biopsy).
. Active or history of autoimmune diseases (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Exceptions: vitiligo, childhood asthma in complete remission without intervention in adulthood.
. Current use of immunosuppressants or systemic corticosteroids (\>10mg/day prednisone equivalent) within 2 weeks prior to enrollment.
. History of severe hypersensitivity to monoclonal antibodies.