Find a Clinical Trial

Trial Description: This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

• Conditions: triple negative breast neoplasms
• Phase: I/II
• Trial ID: NCT03742102
• Protocol ID: 21-198

Trial Description: This research is studying the effect of Antibody-Drug Conjugate Sacituzumab Govitecan in Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer.

• Conditions: breast cancer
• Phase: I/II
• Trial ID: NCT04039230
• Protocol ID: 19-239

Trial Description: This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.

• Conditions: her2 positive breast cancer
• Phase: II
• Trial ID: NCT04539938
• Protocol ID: 20-515

Trial Description: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

• Conditions: her2-positive breast cancer
• Phase: III
• Trial ID: NCT03975647
• Protocol ID: 20-032

Trial Description: This research study is studying a drug called Carboplatin with or without another study drug, Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other parts of the body. The interventions involved in this study are: - Carboplatin - Nivolumab

• Conditions: breast cancer
• Phase: II
• Trial ID: NCT03414684
• Protocol ID: 17-512

Trial Description: This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the study drugs involved in this study are: - VS-6766 - Abemaciclib - Fulvestrant

• Conditions: breast cancer, hormone receptor positive her-2 negative breast cancer, hormone receptor-positive breast cancer
• Phase: I/II
• Trial ID: NCT05608252
• Protocol ID: 22-490

Trial Description: This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone-receptor-positive (HR+), HER2-negative breast cancer (in combination with fulvestrant) or metastatic epithelial ovarian cancer. The names of the medications involved in this study are: - Ribociclib (LEE011) - PDR001 - Fulvestrant

• Conditions: her2-negative breast cancer, metastatic epithelial ovarian cancer, metastatic hormone-receptor-positive (hr+) breast cancer
• Phase: I
• Trial ID: NCT03294694
• Protocol ID: 17-285

Trial Description: This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work

• Conditions: anatomic stage iii breast cancer ajcc v8, anatomic stage iv breast cancer ajcc v8, locally advanced triple-negative breast carcinoma, metastatic triple-negative breast carcinoma, unresectable triple-negative breast carcinoma
• Phase: I
• Trial ID: NCT05422794
• Protocol ID: 22-589

Trial Description: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

• Conditions: breast cancer
• Phase: III
• Trial ID: NCT05501886
• Protocol ID: 23-049

Trial Description: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

• Conditions: pd-l1 positive, triple negative breast cancer
• Phase: III
• Trial ID: NCT05382286
• Protocol ID: 22-485

Trial Description: This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: - Nivolumab (Opdivo ®) - Ipilimumab (Yervoy ®)

• Conditions: breast cancer
• Phase: II
• Trial ID: NCT03789110
• Protocol ID: 18-561

Trial Description: This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

• Conditions: breast cancer
• Phase:
• Trial ID: NCT04739761
• Protocol ID: 22-067

Trial Description: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

• Conditions: breast cancer
• Phase: III
• Trial ID: NCT02574455
• Protocol ID: 17-495

Trial Description: This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: - Sacituzumab govitecan (Trodelvy™;IMMU-132) - Pembrolizumab (Keytruda®; MK-3475)

• Conditions: breast cancer, pd-l1 negative, triple negative breast cancer
• Phase: II
• Trial ID: NCT04468061
• Protocol ID: 20-166

Trial Description: This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope

• Conditions: invasive breast carcinoma, recurrent breast carcinoma, stage iii breast cancer, stage iiia breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer, triple-negative breast carcinoma, unresectable breast carcinoma
• Phase: II
• Trial ID: NCT03971409
• Protocol ID: 22-468

is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18

• Conditions: her2-positive breast cancer
• Phase: Expanded Access
• Trial ID: NCT04395508
• Protocol ID: 20-539

Trial Description: This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one

• Conditions: breast cancer, solid tumor
• Phase: I
• Trial ID: NCT03006172
• Protocol ID: 16-521

Trial Description: This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.

• Conditions: breast cancer
• Phase: I
• Trial ID: NCT03451162
• Protocol ID: 18-111

Trial Description: This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

• Conditions: adenoid cystic carcinoma, advanced solid tumor, cervical cancer, esophageal cancer, gastric cancer, gastroesophageal junction adenocarcinoma, metastatic breast cancer, metastatic colorectal cancer, metastatic head and neck carcinoma, metastatic melanoma, metastatic prostate cancer, metastatic renal cell carcinoma, non small cell lung cancer, ovarian cancer, pancreas cancer, salivary gland cancer, sarcomas, small cell lung cancer, urothelial carcinoma
• Phase: I
• Trial ID: NCT04140526
• Protocol ID: 22-076

Trial Description: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

• Conditions: pd-l1 negative, triple negative breast cancer
• Phase: III
• Trial ID: NCT05382299
• Protocol ID: 22-478

Trial Description: The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

• Conditions: breast cancer
• Phase: III
• Trial ID: NCT05104866
• Protocol ID: 22-044

Trial Description: To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.

• Conditions: breast cancer, ovarian cancer, small cell lung cancer
• Phase: I/II
• Trial ID: NCT04553133
• Protocol ID: 20-537

Trial Description: This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.

• Conditions: breast cancer
• Phase: I
• Trial ID: NCT03332797
• Protocol ID: 17-477

Trial Description: This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer This research study involves an expedited and surgery-specific form of genetic counseling. The names of the study methods involved in this trial are/is: - Quantitative genetic counseling (discussion is guided by tables and graphs) - Standard genetic counseling

• Conditions: breast cancer, genetic testing, in situ breast cancer, invasive breast cancer
• Phase: Feasibility / Pilot
• Trial ID: NCT04245176
• Protocol ID: 19-509

Trial Description: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

• Conditions: breast cancer, non small cell lung cancer
• Phase: II
• Trial ID: NCT02779751
• Protocol ID: 16-216

Trial Description: This clinical trial compares a web-based patient-reported symptom monitoring and self management portal, Young, Empowered & Strong (YES), to standard therapy in managing symptoms in adolescent and young adults breast cancer survivors. YES is a web-based portal (website) to help monitor issues or symptoms women with breast cancer may experience. YES portal may improve the quality of life of young breast cancer survivors. YES portal may help manage symptoms and provide useful information/resources.

• Conditions: anatomic stage 0 breast cancer ajcc v8, anatomic stage i breast cancer ajcc v8, anatomic stage ia breast cancer ajcc v8, anatomic stage ib breast cancer ajcc v8, anatomic stage ii breast cancer ajcc v8, anatomic stage iia breast cancer ajcc v8, anatomic stage iib breast cancer ajcc v8, anatomic stage iii breast cancer ajcc v8, anatomic stage iiia breast cancer ajcc v8, anatomic stage iiib breast cancer ajcc v8, anatomic stage iiic breast cancer ajcc v8, prognostic stage 0 breast cancer ajcc v8, prognostic stage i breast cancer ajcc v8, prognostic stage ia breast cancer ajcc v8, prognostic stage ib breast cancer ajcc v8, prognostic stage ii breast cancer ajcc v8, prognostic stage iia breast cancer ajcc v8, prognostic stage iib breast cancer ajcc v8, prognostic stage iii breast cancer ajcc v8, prognostic stage iiia breast cancer ajcc v8, prognostic stage iiib breast cancer ajcc v8, prognostic stage iiic breast cancer ajcc v8
• Phase: III
• Trial ID: NCT04906200
• Protocol ID: 21-167

Trial Description: This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.

• Conditions: breast neoplasms
• Phase: II
• Trial ID: NCT01670877
• Protocol ID: 13-237

Trial Description: This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.

• Conditions: breast cancer, metastatic prostate cancer, ovarian cancer, pancreatic cancer
• Phase: Not Applicable
• Trial ID: NCT04330716
• Protocol ID: 19-652

Trial Description: This Feasibility study is trying to determine: - If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in demonstrating the drainage to the sentinel lymph nodes in patients with inflammatory breast cancer. - The likelihood of identifying the sentinel lymph nodes in the operating room, using both blue dye and the radioactive substance used for lymphoscintigraphy. - The incidence of lymphedema (arm swelling which occurs after lymph node surgery) in women with inflammatory breast cancer - Outcomes for women with inflammatory breast cancer, whether or not the sentinel lymph nodes can be identified.

• Conditions: breast cancer, inflammatory breast cancer, sentinel lymph node
• Phase: Feasibility / Pilot
• Trial ID: NCT04636710
• Protocol ID: 20-151

Trial Description: This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

• Conditions: breast cancer
• Phase: III
• Trial ID: NCT03778931
• Protocol ID: 19-010

Trial Description: This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.

• Conditions: estrogen receptor status, her2/neu negative, invasive breast carcinoma, postmenopausal, stage iii breast cancer, stage iiia breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer
• Phase: II
• Trial ID: NCT02860000
• Protocol ID: 18-343

Trial Description: This is a modular, Phase I/II, multicentre study to investigate CT7001 monotherapy in advanced solid malignancies and to further investigate CT7001 as monotherapy or in combination with standard therapy in specific participant groups with Triple Negative Breast Cancer (TNBC), Castrate Resistant Prostate Cancer (CRPC) and in combination with fulvestrant for patients with hormone receptor-positive (HR+ve) / human epidermal growth factor-2 negative (HER2-ve) breast cancer.

• Conditions: advanced solid malignancies
• Phase: I/II
• Trial ID: NCT03363893
• Protocol ID: 19-827

Trial Description: The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

• Conditions: early breast cancer
• Phase: III
• Trial ID: NCT02308085
• Protocol ID: 15-717

Trial Description: This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: - Cannabidiol (CBD)

• Conditions: advanced breast cancer, anxiety, cbd
• Phase: II
• Trial ID: NCT04482244
• Protocol ID: 19-886

Trial Description: This research study is comparing telemedicine and face-to-face visits to understand patients' experiences with telemedicine versus face to face visits and to understand when it is and is not appropriate to conduct visits remotely

• Conditions: breast cancer, patient engagement, patient preference, patient satisfaction, prostate cancer
• Phase: Not Applicable
• Trial ID: NCT04936243
• Protocol ID: 21-192

Trial Description: The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.

• Conditions: breast cancer
• Phase: II
• Trial ID: NCT01494662
• Protocol ID: 11-344

Trial Description: The purpose of this study is to determine how well participants with stage II-III HER2-positive breast cancer respond to pre-operative treatment using one of two different combinations of drugs. Drugs and Combinations used: - Paclitaxel, Pertzumab and Margetuximab (Margenza) - Paclitaxel, Pertzumab and Trastuzumab (Herceptin)

• Conditions: breast cancer, her2-positive breast cancer, stage ii breast cancer, stage iii breast cancer
• Phase: II
• Trial ID: NCT04425018
• Protocol ID: 20-068

Trial Description: This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately

• Conditions: hormone receptor positive breast cancer, non-small cell lung cancer, triple negative breast cancer
• Phase: I
• Trial ID: NCT03401385
• Protocol ID: 18-061

Trial Description: The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609 in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal adenocarcinoma (PDAC) .

• Conditions: advanced solid tumor, breast cancer, pancreatic cancer, small-cell lung cancer
• Phase: I
• Trial ID: NCT04247126
• Protocol ID: 20-211

Trial Description: This study is being conducted to carefully study how chemotherapy is tolerated in group of patients age 70

• Conditions: breast cancer
• Phase: Feasibility / Pilot
• Trial ID: NCT03858322
• Protocol ID: 19-031

Trial Description: The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

• Conditions: breast cancer, colon cancer, colorectal cancer, endometrial cancer, neoplasms, ovarian cancer, pancreas cancer, pancreatic cancer, rectal cancer, soft tissue sarcoma, solid tumors, triple negative breast cancer
• Phase: I
• Trial ID: NCT02632448
• Protocol ID: 18-524

Trial Description: This study consists of two parts. Part 1 is a dose-escalation/safety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2. Following the identification of a recommended dose and regimen from Part 1, the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors, and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology

• Conditions: advanced solid tumors, breast cancer, ovarian cancer
• Phase: I
• Trial ID: NCT03134638
• Protocol ID: 17-236

Trial Description: This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form

• Conditions: anatomic stage ii breast cancer ajcc v8, anatomic stage iia breast cancer ajcc v8, anatomic stage iib breast cancer ajcc v8, anatomic stage iiia breast cancer ajcc v8, invasive breast carcinoma, prognostic stage ii breast cancer ajcc v8, prognostic stage iia breast cancer ajcc v8, prognostic stage iib breast cancer ajcc v8, prognostic stage iiia breast cancer ajcc v8
• Phase: II
• Trial ID: NCT04266249
• Protocol ID: 20-189

Trial Description: This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors. The study will consist of three phases: phase 1a (dose escalation with ZN-A-1041 monotherapy), phase 1b (dose escalation with ZN-A-1041 in combination with Capecitabine and Trastuzumab) and phase 1c (dose expansion with ZN-A-1041 in combination with Capecitabine and Trastuzumab

• Conditions: advanced solid tumors, her2-positive breast cancer
• Phase: I
• Trial ID: NCT04487236
• Protocol ID: 20-683

Trial Description: This is an open label, Phase 1b/2 study with multiple treatment arms evaluating the safety, tolerability, PK, and preliminary efficacy of rucaparib in combination with a second anticancer therapy in patients with an advanced/metastatic solid malignancy (Phase 1b), followed by evaluation of the combination in one or more specific patient populations in an expansion phase (Phase 2 cohorts).

• Conditions: ovarian cancer, solid tumor, triple-negative breast cancer, urothelial carcinoma
• Phase: I/II
• Trial ID: NCT03992131
• Protocol ID: 19-168

Trial Description: This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers.

• Conditions: breast cancer, symptom behavioral
• Phase: II
• Trial ID: NCT04379414
• Protocol ID: 20-124

Trial Description: Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled. They will receive local therapy with stereotactic radiosurgery ± surgical resection if indicated followed by enrollment. Patients will continue standard of care trastuzumab/pertuzumab or T-DM1 with the addition of tucatinib. Hormone receptor positive patients requiring endocrine therapy should continue. Study treatment will continue until disease progression or intolerable side effects. Patients on trial with extracranial disease progression with stable intracranial disease should continue tucatinib into next line of therapy.

• Conditions: advanced breast cancer, brain metastases, human epidermal growth factor 2 positive carcinoma of breast
• Phase: II
• Trial ID: NCT05323955
• Protocol ID: 22-671

Trial Description: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

• Conditions: anatomic stage ia breast cancer ajcc v8, anatomic stage ii breast cancer ajcc v8, anatomic stage iia breast cancer ajcc v8, anatomic stage iib breast cancer ajcc v8, anatomic stage iii breast cancer ajcc v8, anatomic stage iiia breast cancer ajcc v8, anatomic stage iiib breast cancer ajcc v8, anatomic stage iiic breast cancer ajcc v8, her2 positive breast carcinoma, invasive breast carcinoma, multifocal breast carcinoma, prognostic stage i breast cancer ajcc v8, prognostic stage ia breast cancer ajcc v8, prognostic stage ib breast cancer ajcc v8, prognostic stage ii breast cancer ajcc v8, prognostic stage iia breast cancer ajcc v8, prognostic stage iib breast cancer ajcc v8, prognostic stage iii breast cancer ajcc v8, prognostic stage iiia breast cancer ajcc v8, prognostic stage iiib breast cancer ajcc v8, prognostic stage iiic breast cancer ajcc v8, synchronous bilateral breast carcinoma
• Phase: III
• Trial ID: NCT04457596
• Protocol ID: 21-560

Trial Description: This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of [225Ac]-FPI-1434 (radioimmuno-therapeutic agent) in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547 (radioimmuno-imaging agent), and to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of repeat doses of [225Ac]-FPI-1434 Injection in patients with solid tumours that demonstrate uptake of [111In]-FPI-1547 (radioimmuno-imaging agent

• Conditions: adrenocortical carcinoma, advanced solid tumours, breast cancer, cervical cancer, endometrial cancer, head and neck squamous cell carcinoma (hnscc), her2-negative breast cancer, ovarian cancer, triple negative breast cancer (tnbc), uveal melanoma
• Phase: I
• Trial ID: NCT03746431
• Protocol ID: 19-824

Trial Description: This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.

• Conditions: anatomic stage iv breast cancer ajcc v8, invasive breast carcinoma, metastatic her2 negative breast carcinoma, metastatic malignant neoplasm in the brain, prognostic stage iv breast cancer ajcc v8
• Phase: II
• Trial ID: NCT04647916
• Protocol ID: 21-531