Pooja P. Advani, M.B.B.S., M.D.

The goal of this clinical trial is to evaluate the safety and efficacy of 3 different dose levels of CLR 125 in patients with advanced triple negative breast cancer. The main questions the study aims to answer are:

* What dose and regimen should be used in future trials of CLR 125 in patients with advanced triple negative breast cancer.
* What side effects do participants have when taking CLR 125.

Participants will:

* Have CLR 125 administered via infusion 4 times each cycle; repeated every 8 weeks.
* Visit the clinic once every 3 weeks for checkups and testing.
* Report any side effects or new medications.

Some participants may also receive one dose of CLR 131 to evaluate the amount of radiation delivered to various organs and to the tumor. These participants will:

* Have 4 scans completed over 2 weeks
* Have blood drawn 6 times over 2 weeks.

The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor.   

This is a multicenter, Phase 1b/2 trial. The purpose of phase 1b part of the trial aims to determine the  recommended phase II dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the effectiveness and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

The purpose of this study is to explore and describe metastatic breast cancer (mBC) and metastatic urothelial cancer (mUC) patient perspectives on and experiences with treatment decision-making, including how patients evaluate various treatment options, associated benefits, risks and drawbacks as well as how perceptions and preferences change over time.

The purpose of this study is to test the safety, side effects, and best dose of ASTX727 when given together with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). 

The purpose of this study is to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.

The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.

The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%.

A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.

Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

The purpose of this study is to investigate the antitumor activity of navicixizumab monotherapy or in combination with paclitaxel or irinotecan in patients with advanced solid tumors including:

• Cohort A: Colorectal cancer (CRC);
• Cohort B: Gastric and gastroesophageal junction (GEJ) cancer;
• Cohort C: Triple-negative breast cancer (TNBC);
• Cohort D: Platinum-resistant/refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer (ovarian cancer).

The purpose of this study is designed to evaluate the effectiveness and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic Triple Negative Breast Cancer (TNBC); Notch activation will be determined by a Next Generation Sequencing (NGS) test.

The purpose of this study is to assess the effectiveness of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after Aromatase Inhibitor (AI) therapy.

The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.

The purpse of this study is to evaluate the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2− breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.

The purpose of this study is to assess if camizestrant improves outcomes compared to standard endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). 

The purpose of this study is to evaluate the effectiveness and tolerability of cryotherapy (cold therapy) in the form of Elasto Gel® frozen mittens and foot wraps to determine whether or not they can prevent or ameliorate taxane-induced sensory peripheral neuropathy. The hypothesis of our pilot study is that patients receiving cryotherapy during infusion of taxane therapy will have lower incidence of peripheral neuropathy, better physical function, and higher quality of life as compared to patients previously reported in literature.

The primary purpose of the Safety-Run-in Cohort 1 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with nab-paclitaxel or paclitaxel. In Phase 2 Cohort 1, the study will compare the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or paclitaxel alone as determined by
progression-free survival (PFS) by investigator assessment

The primary purpose of the Safety-Run-in Cohort 2 of this study is to evaluate the safety, tolerability, and recommended Phase 2 dose of magrolimab in combination with sacituzumab govitecan. In Cohort 2 (Safety Run-in Cohort 2 and Phase 2 Cohort 2) the study will evaluate the efficacy of magrolimab in combination with sacituzumab govitecan as
determined by confirmed objective response rate (ORR) by investigator assessment

Aim 1: Determine the basal profile of non-genomic factors in patients at the time of exposure to SARS-CoV-2 and correlate with the three clinical patient outcome categories (A, B, C) as observed through their clinical course. 

Hypothesis: Baseline cytokine (IL-1β, IL-6, IL-4, IL-10, IFN-g and TNF-a) and the immune cellular repertoire (helper/CD4+, cytotoxic/CD8+, T-regulatory cells, natural killer cells) constitute the inherent biologic immunity of an individual and underpins their vulnerability to SARS-CoV-2 infectivity and/or its subsequent sequalae. 

Aim 2: Investigate if mutations or polymorphisms in genes (CXCR6, ACE2 and SLC6A20) linked to SARS-CoV-2 correlates with the three clinical patient outcome categories (A, B, C) as observed through their clinical course.

Hypothesis: ACE2 is a cellular receptor for SARS-CoV-2. The high binding affinity of ACE2 to SARS-CoV-2 is determined by its gene sequence and polymorphisms in the ACE2 gene itself or those that regulate ACE2 function (i.e. SLC6A20) can alter this binding potential and thus the clinical impact of the virus. 

Aim 3:  Develop an integrated model of non-genomic (Aim 1) and genomic (Aim 2) factors for prediction of the three potential clinical courses of an individual upon exposure to SARS-CoV-2.  

Hypothesis:  An integrated model incorporating quantitative analysis of cytokines/immune cells (Aim 1) and gene sequence analysis (Aim 2) will allow a more robust and accurate prediction for one of the three potential clinical courses (A, B, C) after SARS-CoV-2 exposure.  

The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.

The primary objective of this study is to compare progression-free survival (PFS) in patients with advanced HER2-positive breast cancer treated with T-DM1 and abemaciclib vs. T-DM1 monotherapy.

RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.