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. 2020 Sep 3;5(4):e1274. doi: 10.1002/cnr2.1274

TABLE 2.

Available clinical trials for HER2‐positive breast cancer brain metastases (BCBrM)

NCT Title Intervention Eligibility
03994796 (Phase II) Genomically‐guided treatment trial in brain metastases Palbociclib or GDC‐0084 or entrectinib, dependent on presence of gene mutation

  • Clinically actionable alteration in NTRK, ROS1, or CDK or PI3K pathway a

  • At least one prior HER2 directed therapy in the metastatic setting
03190967 (Phase I/II) T‐DM1 alone vs T‐DM1 and metronomic temozolomide in secondary prevention of HER2‐positive breast cancer brain metastases following stereotactic radiosurgery Phase I: T‐DM1 b + temozolomide Phase II: randomization T‐DM1 + or ‐ temozolomide
Phase I:
  • Any number of brain metastases treated with SRS/WBRT within 12 weeks of study entry
Phase II:
  • Up to 10 brain metastases treated within 12 weeks of study entry with SRS and/or resection
03417544 (Phase II) A Phase II study of atezolizumab in combination with pertuzumab plus high‐dose trastuzumab for the treatment of central nervous system metastases in patients with HER2‐positive breast cancer Trastuzumab + pertuzumab + atezolizumab

  • At least one measurable CNS metastasis, defined as ≥10 mm in at least one dimension

  • Untreated CNS lesions in asymptomatic patients

  • Treated SRS or surgery with untreated and measurable residual areas

  • Prior WBRT and/or SRS with lesions subsequently progressed are also eligible
03696030 (Phase I) A Phase 1 cellular immunotherapy study of intraventricularly administered autologous HER2‐targeted chimeric antigen receptor (HER2‐CAR) T cells in patients with brain and/or leptomeningeal metastases from HER2‐positive cancers HER2‐CAR T c cells via intraventricular administration

  • Recurrent brain metastases after radiation therapy

  • Recurrent leptomeningeal metastases after intrathecal chemotherapy

  • Untreated brain or leptomeningeal metastases and refuses to undergo radiation and/or intrathecal chemotherapy

  • Eligible to enroll in the study and undergo leukapheresis
02442297 (Phase I) Phase I Study of intracranial injection of t cells expressing HER2‐specific chimeric antigen receptors (CAR) in subjects with HER2‐positive tumors of the central nervous system (iCAR) HER2‐CAR T cells via intraventricular administration

  • HER2‐positive solid tumor metastatic to the CNS
03765983 (Phase II) Phase II trial of GDC‐0084 in combination with trastuzumab for patients with HER2‐positive breast cancer brain metastases Trastuzumab + GDC‐0084 (PI3K inhibitor)
Cohort A:
  • At least one measurable CNS metastasis, defined as ≥10 mm in at least one dimension
  • Untreated CNS lesions in asymptomatic patients
  • Treated SRS or surgery with untreated and measurable residual areas
  • prior WBRT and/or SRS with lesions subsequently progressed are also eligible
Cohort B:
  • New and/or progressive brain metastasis(es) with clinical indication for resection
01494662 (Phase II) A Phase II trial of HKI‐272 (neratinib), neratinib and capecitabine, and ado‐trastuzumab emtansine for patients with human epidermal growth factor receptor 2 (HER2)‐positive breast cancer and brain metastases

Different cohorts receiving:

neratinib alone, neratinib + capecitabine, neratinib + T‐DM1

 Cohort dependent, either resectable brain metastases or not
03933982 (Phase II) Pyrotinib plus vinorelbine in patients with brain metastases from HER2‐positive metastatic breast cancer: a prospective, single‐arm, open‐label study Pyrotinib + vinorelbine

  • At least one CNS metastases with a longest diameter ≥ 1 cm and

  • Controlled CNS symptoms

  • No previous WBRT
03975647 (Phase III) Randomized, double‐blind, phase 3 study of tucatinib or placebo in combination with ado‐trastuzumab emtansine (T‐DM1) for subjects with unresectable locally‐advanced or metastatic HER2+ breast cancer (HER2CLIMB‐02) Tucatinib + T‐DM1 vs placebo + T‐DM1 Brain metastases patients allowed with:

  • untreated brain metastases and no need of immediate local therapy

  • previously treated brain metastases, either stable or progressing in no need of immediate local therapy

  • recently treated brain metastases (21 d post WBRT or 28 d after surgical resection)
a

NTRK, neurotrophin receptor tyrosine‐kinase; ROS1, ROS proto‐oncogene 1; CDK, cyclin dependent kinase; PI3K, phosphatidylinositol‐3‐kinase.

b

T‐DMI1, ado‐trastuzumab emtansine; SRS, stereotactic radiosurgery; WBRT, whole‐brain radiotherapy.

c

CAR, chimeric antigen receptor.