Health TrialsbyHealthPanel

Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases

ConditionsTNBCBrain Metastasis
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Tirumotecan (Sac-TMT)

    Drug

    Eligible patients will receive a dosage of sac-TMT 4mg/kg Q2W

  • bevacizumab

    Drug

    safety run-in phase: bevacizumab 10mg/kg D1 Q2W Dose expansion phase: bevacizumab RP2D D1 Q2W

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Sacituzumab Tirumotecan (Sac-TMT) plus BevacizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

CNS ORR

The proportion of patients who have a CR or PR in the CNS, as determined by the Investigator according to RANO-BM criteria

Time frame
from enrollment to progression or death (for any reason), assessed up to 24 months

Secondary outcomes

1

CNS CBR

CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.

Time frame
from enrollment to progression or death (for any reason), assessed up to 24 months
2

Progression-free survival

PFS will be defined as the time from the first dose of treatment to death or disease progression

Time frame
Up to 2 years
3

Overall survival

OS will be defined as the time from the first dose of treatment to death for any cause

Time frame
Up to 2 years
4

First progression site

The first lesion to progress

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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