QBS72S for Brain Cancer from Breast Cancer
Palo Alto (17 mi)Overseen byMelanie H Gephart, MD, MAS
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Melanie Hayden Gephart
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called QBS72S for people with advanced breast cancer that has spread to the brain. The goal is to see if this drug can shrink brain tumors and help patients live longer. Researchers are also checking if the drug is safe for these patients.
Is the drug QBS72S a promising treatment for brain cancer from breast cancer?QBS72S is a promising drug for treating brain cancer that has spread from breast cancer because it may help overcome the blood-brain barrier, which usually blocks cancer drugs from reaching brain tumors. This is important because brain cancer from breast cancer is often hard to treat and has a high death rate. New treatments like QBS72S could offer hope for better outcomes.124612
What safety data exists for QBS72S treatment for brain cancer from breast cancer?The provided research does not contain specific safety data for QBS72S or its variants (NBQ72S, QBS 10072S, QBS 72S). The studies focus on other treatments and aspects of breast cancer with brain metastases, such as the efficacy of tucatinib in the HER2CLIMB trial and the impact of serum-derived factors on the blood-brain barrier. Therefore, no safety data for QBS72S is available in the given research.378912
Do I have to stop taking my current medications for the trial?The trial protocol requires a washout period for certain medications before starting the study. You must stop taking small molecules and non-cytotoxic systemic drugs 14 days before, checkpoint inhibitors and monoclonal antibodies 21 days before, and investigational drugs, radiotherapy, and major surgery 28 days before. For corticosteroids and anticonvulsants, you must be on stable or decreasing doses for at least 5 days before the screening MRI. Some medications, like live vaccines and certain anticonvulsants, are not allowed during the trial. Please consult with the study team for specific guidance on your medications.
What data supports the idea that QBS72S for Brain Cancer from Breast Cancer is an effective treatment?The available research does not provide specific data on the effectiveness of QBS72S for treating brain cancer from breast cancer. However, it does mention other treatments like tucatinib, which showed significant improvement in survival for patients with brain metastases from HER2-positive breast cancer. This suggests that there are effective treatments available, but specific data on QBS72S is not provided in the research.4591011
Eligibility Criteria
Adults with advanced breast cancer that has spread to the brain, who've had prior chemotherapy. They must be able to consent, follow study procedures, and have good organ function and performance status. Contraception is required for those who can conceive. Exclusions include recent major surgery, certain medical conditions or treatments, high steroid doses, severe drug allergies, other active cancers within 3 years (except some skin cancers), pregnancy/breastfeeding.Treatment Details
The trial tests QBS72S's effectiveness and safety in treating brain metastases from breast cancer. Participants will receive this investigational drug after completing previous treatments including chemo and radiotherapy as per specified waiting periods.
3Treatment groups
Experimental Treatment
Group I: Patients with any Primary Cancer Leptomeningeal Disease (Cohort 3)Experimental Treatment1 Intervention
All participants in Cohort 3 will receive QBS72S IV injections once monthly until disease progression.
Group II: Patients with Breast Cancer Parenchymal brain metastasis (Cohort 1)Experimental Treatment1 Intervention
All participants in Cohort 1 will receive QBS72S IV injections once monthly until disease progression.
Group III: Patients with Breast Cancer Leptomeningeal Disease (Cohort 2)Experimental Treatment1 Intervention
All participants in Cohort 2 will receive QBS72S IV injections once monthly until disease progression.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stanford Cancer InstitutePalo Alto, CA
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Who is running the clinical trial?
Melanie Hayden GephartLead Sponsor
Quadriga Biosciences, Inc.Industry Sponsor
References
Prognostic significance of glycoprotein pMQ1 in breast cancer. [2006]A novel glycoprotein, pMQ1, is positively correlated with increasing histological grade in malignant astrocytomas. Cerebral metastases from breast cancer have also been found to contain pMQ1-positive cells. This study aimed to determine the role of pMQ1 in primary breast cancer.
New challenges and opportunities in the management of brain metastases in patients with ErbB2-positive metastatic breast cancer. [2018]The introduction of trastuzumab for the treatment of tumors that overexpress ErbB2 (also known as HER2) has contributed significantly to recent improvements in systemic therapy for advanced breast cancer. The advances in systemic therapy have highlighted an increasing prevalence of central nervous system involvement in patients with ErbB2-positive breast cancer and a consequent need for new treatment options for brain metastases. Just as ErbB2-targeted systemic therapy has given rise to this challenge, so too could targeted therapy represent an opportunity to meet it. This Review considers the potential for targeted therapy to facilitate effective management of brain metastases in patients with ErbB2-positive breast cancer, and discusses in particular the data currently available in this setting for lapatinib, an orally available small-molecule tyrosine kinase inhibitor of ErbB1 and ErbB2.
Limited overall survival in patients with brain metastases from triple negative breast cancer. [2014]Patients with breast cancer, which lacks ER, PR, and HER2; "triple negative" (TNBC), are at increased risk of brain metastases (BMs). However, the impact of modern therapy on the risk of BMs and outcomes remains largely unknown. In this retrospective, single-institution study we assessed the incidence of BMs, the therapeutic options, and overall survival, in a recent cohort of patients with TNBC. Women diagnosed with early stage TNBC from January 1, 1998 to December 31, 2007 were identified through institutional databases. Electronic medical records were reviewed to assess patterns of recurrence, treatment, and survival. In total, 1,323 patients, median age 53 years (range 20-91), were identified. There were 298 patients (23%) who developed metastatic disease, of whom, 99 (33%) developed BMs, representing 7.5% of the entire cohort. Following BM diagnosis, treatment consisted of: radiotherapy 87 (88%) patients, resection 26 (26%) patients, and systemic chemotherapy 70 (71%) patients, with a median of 1.0 (range 0-8) chemotherapy regimens. The actuarial median survival from diagnosis of BMs is 5 months (95% CI 4-7 months). This single-institution, retrospective study confirms that the prognosis for patients with BMs from TNBC remains poor. This group of patients urgently needs improved therapies.
Risk factors and survival outcomes in patients with brain metastases from breast cancer. [2022]Development of central nervous system (CNS) metastases in breast cancer (BC) is associated with poor prognosis. The incidence of CNS metastases in metastatic BC is reported to be about 10-16 %, but different subtypes of BC are associated with different risk of developing CNS metastases. We retrospectively analysed the risk of CNS metastases and the outcome in a cohort of 473 patients with metastatic BC. CNS metastases were diagnosed in 15.6 % of patients and median survival from diagnosis of CNS metastases was 7.53 (25th-75th 2.8-18.9) months. The risk of developing CNS metastases was higher in patients with grade 3, hormone receptor negative, HER2-positive, high Ki-67 BC. When compared to luminal A subtype, only HER2-positive BC was associated with increased risk of CNS metastases. Survival from diagnosis of CNS metastases was longer in patients with HER2-positive BC, while it was shorter in patients that did not receive any locoregional treatment, or with extra-CNS disease, or with more than 3 CNS lesions.
Identification of breast cancer patients with a high risk of developing brain metastases: a single-institutional retrospective analysis. [2022]The objective of this study was to identify breast cancer patients with a high risk of developing brain metastases who may benefit from pre-emptive medical intervention.
Identification of Novel Agents for the Treatment of Brain Metastases of Breast Cancer. [2018]Brain cancer from metastasized breast cancer has a high mortality rate in women. The treatment of lesions is hampered in large part by the blood-brain barrier (BBB), which prevents adequate distribution of anti-cancer compounds to brain metastases.
Identification of the key pathways and genes involved in HER2-positive breast cancer with brain metastasis. [2020]The risk of brain metastasis (BM) in HER2-positive (+) breast cancer (BC) patients is significantly higher than that in HER2-negative (-) BC patients. The high incidence and mortality rate makes it urgent to elucidate the key pathways and genes involved and identify patients who are more at risk of developing BM.
Serum-derived factors of breast cancer patients with brain metastases alter permeability of a human blood-brain barrier model. [2020]The most threatening metastases in breast cancer are brain metastases, which correlate with a very poor overall survival, but also a limited quality of life. A key event for the metastatic progression of breast cancer into the brain is the migration of cancer cells across the blood-brain barrier (BBB).
Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. [2023]In the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs.
A pre-operative MRI-based brain metastasis risk-prediction model for triple-negative breast cancer. [2022]Triple-negative breast cancer (TNBC) patients have a high 2-year post-operative incidence of brain metastasis (BM). Currently, there is no early prediction tool to predict the risk of BM in TNBC patients.
Exclusion of Patients With Brain Metastases in Published Phase III Clinical Trials for Advanced Breast Cancer. [2022]Metastatic HER2-positive (HER2+) and triple-negative breast cancer (TNBC) confer a 30% or higher risk of developing brain metastases (BrM), but BrM is typically an exclusion criteria for clinical trials, which limits the generalizability of trial results to these patients. We therefore analysed trends in the enrollment of patients with BrM, as well as the use of outcomes specific to the central nervous system (CNS), in phase III clinical trials evaluating systemic therapy for patients with advanced HER2+ and/or TNBC. Notably, 10 of the 34 trials (29%, 95% confidence interval = 15.1%-47.5%) evaluated CNS-specific outcomes and trials that completely excluded patients with BrM were significantly less likely to meet their primary endpoint (n = 6/17, 35%) than those that permitted conditional enrollment (n = 13/15, 87%) (P = .005), suggesting that enrollment of patients with BrM is not detrimental to trial success.
Preclinical and clinical activity of DZD1516, a full blood-brain barrier-penetrant, highly selective HER2 inhibitor. [2023]Patients with HER2-positive metastatic breast cancer (MBC) are at high risk of developing central nervous system (CNS) metastases. A potent and selective HER2 inhibitor with good blood-brain barrier (BBB) penetration is highly desirable.