Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Breast Neoplasms

Brain Neoplasms

Neoplasm Metastasis

Neoplasms, Second Primary

Breast Diseases

Skin Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Alovudine

Antineoplastic Agents, Immunological

Antiviral Agents

GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

GRN1005

2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice

5 mCi of 18F-FLT IV during Screening and during Cycle 1

18F-FLT

Betty Lawrence

Nancy Lin, MD

Susan Bates, MD

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.

In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

Angiochem Inc

Capecitabine

Bevacizumab

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

pyrotinib: ≥160mg qd capecitabine: 1000mg/m2,bid,q1-14,q3w bevacizumab:7.5mg/kg,iv,q3w

pyrotinib+capecitabine+bevacizumab

Chao tengfei

This study intends to conduct a small, prospective, single-center clinical study to explore and evaluate the efficacy and safety of pyrrotinib combined with capecitabine and bevacizumab in HER2-positive advanced breast cancer with brain metastases.The overall objective is to provide a new drug regimen for HER2 positive breast cancer patients with brain metastases by balancing survival benefits and patient quality of life.

Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases

Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases：a Single-arm,Prospective,Phase II Study

Assess the response rate in the CNS by MRI according to modified Response Assessment in modified RECIST 1.1 criteria. Objective CNS response is defined as at least 30% decrease in the sum of diameters of CNS target lesions in the absence of new lesions (defined as ≥ 6 mm), increased steroid use, progressive neurological symptoms, and progressive extra-CNS disease as assessed by RECIST 1.1. Confirmatory scans are not required.

Time to CNS progression will be defined as the time from treatment initiation to documented disease progression (modified RECIST 1.1 criteria) in the CNS

OS is defined as the time from treatment initiation until death due to any cause

PFS is defined as the time from treatment initiation to documented disease progression

Evaluate systemic ORR defined as partial response or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Refers to the proportion of patients with a clinically significant adverse event (AE) (ie, leading to treatment modification or discontinuation, patient hospitalization, death, or permanent sequelae) documented in the medical records.

Tongji Hospital

Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology

Recurrence

Triple Negative Breast Neoplasms

Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.

ANG1005

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.

ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases	NCT01480583	Breast Cancer Brain Metastase...	GRN1005 Trastuzumab 18F-FLT	18 Years -	Angiochem Inc
Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases	NCT06152822	Breast Cancer W...	pyrotinib+capec...	18 Years -	Tongji Hospital
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases	NCT02048059	Breast Cancer Brain Metastase...	ANG1005	18 Years -	Angiochem Inc

Spots Global Cancer Trial Database for breast cancer with brain metastases