Health TrialsbyHealthPanel

SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases

ConditionsTNBCBrain Metastasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old, both genders

ECOG Performance Status of 0-2

Pathological tests confirm HR-negative/HER2-negative breast cancer；there is evidence of local recurrence or 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(-)

Must have life-expectancy of ≥ 3 months

Disqualifiers

Leptomeningeal or cystic 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

Has received prior therapy with bevacizumab and TROP-2 ADC drugs

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A1921 + Bevacizumab

    Drug

    SHR-A1921 + Bevacizumab

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: SHR-A1921 + BevacizumabExperimental treatment 1 intervention

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

This trial is not recruiting at the moment. You can still explore other options: