Breast Cancer Metastatic Clinical Trial
Official title:
Multicenter Open-label, Phase II Trial, to Evaluate the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Patients With HER2-negative Breast Cancer (The Phenomenal Study)
Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI in patients with HER2-negative breast cancer, who have documented Central Nervous System (CNS) progression following Whole Brain Radio Therapy (WBRT), Stereotactic Radiosurgery (SRS) and/or surgery, as determined by the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
This is an international, prospective, open-label, multicenter, single arm, two-stage Simon Design phase II clinical trial, with the primary objective of assessing the efficacy of nal-IRI single agent in a cohort of HER2-negative metastatic breast cancer (MBC) patients with CNS involvement. Eligible patients will have histologically proven diagnosis of adenocarcinoma of the breast, they must have progressed to at least one prior chemotherapy regimen in the metastatic setting and must have been progressed in CNS to previous local treatment (Surgery and/or WBRT and/or SRS) showing at least one measurable lesion in the CNS (symptomatic meningeal carcinomatosis is not permitted). Eligible patients must have been previously received at least treatment with taxanes (either in the neo/adjuvant or in the metastatic scenario). Patients could not be eligible if they are candidates for a local treatment with a radical intention. Patients will be accrued in a two-stage design. Considering a drop-out rate of 10%, the accrual goal will be a total of 63 patients in both stages (first stage will include 23 evaluable patients and the second stage will include 33 more evaluable patients). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04509596 -
DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04122469 -
The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease
|
N/A | |
| Completed |
NCT03045653 -
Efficacy of High Dose Tamoxifen to Advanced Hormone Receptor-High Expressed Breast Cancer
|
Phase 2 | |
| Terminated |
NCT03322215 -
HR+/HER2- Advanced Breast Cancer and Endocrine Resistance
|
Phase 2 | |
| Active, not recruiting |
NCT04059484 -
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT04368442 -
Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation
|
||
| Terminated |
NCT03709082 -
Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT03642990 -
NR in Chemo-induced Peripheral Neuropathy
|
Phase 2 | |
| Terminated |
NCT01876251 -
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04483505 -
Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer.
|
Phase 1 | |
| Recruiting |
NCT03086785 -
Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
|
Phase 2 | |
| Terminated |
NCT04197999 -
A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT06439693 -
The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT03638765 -
Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT06100874 -
A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
|
Phase 2 | |
| Completed |
NCT05609903 -
Atezolizumab With Nab-paclitaxel for Patients With Triple-negative Stage IV Breast Cancer
|
||
| Active, not recruiting |
NCT04597580 -
Personalised Disease Monitoring in Metastatic Breast Cancer
|
||
| Completed |
NCT05301530 -
Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients.
|
Phase 1 | |
| Recruiting |
NCT05837533 -
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
|
N/A |