Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a single-arm, multi-center phase II study to evaluate the safety and efficacy Sacituzumab Tirumotecan (Sac-TMT) plus bevacizumab in triple-negative breast cancer patients with brain metastases. Twenty-four participants are planned to be enrolled. The eligible patients should have histologically or cytologically confirmed TNBC with BM.
Eligibility criteria
Qualifiers
Age ≥ 18 years old, regardless of gender;
ECOG Performance Status of 0-2;
Histologically or cytologically confirmed HR-negative and HER2-negative breast cancer; there is evidence of metastasis; not suitable with curative surgery or radiation therapy; HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is < 10%; HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-);
MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy; For lesions with prior radiotherapy, progressive disease post radiotherapy must be confirmed by MRI
Disqualifiers
Pial metastases confirmed by MRI or lumbar puncture;
Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment;
Prior use of bevacizumab or other anti-angiogenic agents is prohibited, except for the following scenarios:a)No disease progression occurred during bevacizumab treatment, no confirmed drug resistance was identified, and the investigator deems continued use beneficial for the participant;b)Short-course bevacizumab was administered solely for the management of cerebral edema
Trial design
Treatments tested in this trial
- Sacituzumab Tirumotecan (Sac-TMT)
- bevacizumab
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov