QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University

About this trial

This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC

Eligibility criteria

Qualifiers

Voluntarily join this study and sign the informed consent form;

Female patients aged ≥18 years and ≤70 years old who had been dignosed with breast cancer;

According to the definition of the latest ASCO/CAP guidelines, histologically confirmed estrogen receptor negative (ER-) and progesterone receptor negative (PR-), human epidermal growth factor receptor 2 negative

For patients with locally advanced, recurrent or metastatic breast cancer who have not used any systematic treatment (it is allowed to accept adjuvant/neoadjuvant treatment, and the time from the last administration to recurrence and metastasis should be ≥ 6 months);

Disqualifiers

1.The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2.Are currently using immunosuppressants or systemic steroid therapy to achieve immunosuppression ((in dosing exceeding 10 mg daily of prednisone equivalent), and are still using it within 2 weeks before enrollment; 3.Severe allergic reactions to other monoclonal antibodies; 4. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 5.Known central nervous system metastasis; 6.Known additional malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ); 7. The presence of uncontrolled hypertension (systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg) or dignosis with hypertensive crisis or hypertensive encephalopathy. Known history of hypertension are admitted to the study if their blood pressure is controlled below this standard and maintained with antihypertensive therapy.

Trial design

Treatments tested in this trial

  • bevacizumab
  • QL1706
  • Nab paclitaxel

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators