Breast Cancer
Conditions
Keywords
breast caner, HER2 positive
Brief summary
The aim of this project is to evaluate whether the sequence of Trastuzumab，pyrotinib and Nab-Paclitaxel in first line followed by SHR-A1811 in second line is superior to the sequence of SHR-A1811 in first line followed by Trastuzumab，pyrotinib and Nab-Paclitaxel in second line for HER2 positive breast cancer brain metastases.
Interventions
DRUGSHR-A1811,tratuzumab,pyrotinib,Nab-Paclitaxel
SHR-A1811:4.8mg/kg tratuzumab:Initial 8mg/kg followed by 6mg/kg pyrotinib:320mg Nab-Paclitaxel:100-150mg/m2
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Females ≥18 yrs old 2. Pathologically confirmed HER2-positive advanced breast cancer; 3. Newly diagnosed brain metastes,At least one measurable intracranial lesion 4. Not received any systemic treatment for advanced stage 5. Radiotherapy was allowed in patients with an urgent need for control of intracranial symptoms 6. Adequate function of major organs 7. Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.
Exclusion criteria
1.Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture; 2.Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage; 3.Has received whole brain radiotherapy, chemotherapy, surgery within 2 weeks before first dose of study therapy; 4.Has known clinically significant lung disease, that is, moderate-to-severe lung disease which severely affects respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonitis. Prior ≥ grade 3 interstitial lung disease is not allowed to enrolment; 5.Has received full-dose anticoagulants or thrombolytics within 10 days before enrolment, or non-steroid anti-inflammatory drugs with platelet inhibition 6.Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 7.Participated in other drug clinical trials within 4 weeks before admission; 8.Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS2 | 2 years | Progression-free survival after two lines of treatment (PFS2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | 4 years | Date of randomization until date of death due to any cause |
| Intracranial CNS progression-free survival | 2 years | Time from randomization to progression of intracranial lesions |
| Progression-free survival | 2 years | Time from randomization to disease progression |
| adverse event | 2 years | The proportion of patients with adverse reactions according to CTCAE5.0 |
Contacts
Primary ContactJing Yao
Outcome results
None listed