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HER2 clinical trials at UC Cancer
29 research studies open to eligible people

  • A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

    open to eligible people ages 18 years and up

    Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion as both a single agent and in combination with endocrine therapy.

    at UCLA UCSF

  • A Study of Experimental Medicine Pyrotinib For HER2-Positive Solid Tumors

    open to eligible people ages 18 years and up

    Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other solid tumors that have no targeted agent as standard of care). Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at the RP2D (or MTD).

    at UC Davis UC Irvine

  • A Study of Experimental Tucatinib vs. Placebo Combined With Ado-trastuzumab Emtansine (T-DM1) for HER2+ Breast Cancer

    open to eligible people ages 18 years and up

    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.

    at UC Davis UC Irvine

  • A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

    open to eligible people ages 18 years and up

    A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

    at UCLA UCSF

  • An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

    open to eligible people ages 18 years and up

    An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

    at UCLA UCSF

  • Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Neratinib, With or Without Trastuzumab

    open to eligible people ages 18 years and up

    This is a study to evaluate the toxicity profile of neratinib in combination with trastuzumab in patients with early stage breast cancer with the use of anti-diarrheal prophylaxis. The anti-diarrheal medications being tested in this trial are loperamide and crofelemer. Crofelemer is an anti-diarrheal, enteric-coated drug product for oral administration. It is the only botanical drug currently approved by the FDA for oral administration and is approved for the treatment of diarrhea associated with HAART. Crofelemer has a novel mechanism of action, acting directly and simultaneously on 2 distinct intestinal luminal chloride channels. It is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl-) channel found on the apical membranes, and the calcium-activated Cl- channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl-channel and CaCC regulate Cl and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl- secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl- and water in the GI tract.

    at UCSF

  • Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

    open to eligible people ages 18 years and up

    This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

    at UC Davis UCSD

  • DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

    open to eligible people ages 18 years and up

    This study will find out if trastuzumab deruxtecan is safe and works for participants with certain kinds of cancer. They must have HER2-positive gastric or gastro-esophageal junction (GEJ) cancer: - that cannot be removed surgically - that has moved to other parts of the body - that got worse during or after treatment that included trastuzumab The study will enroll about 72 participants at about 25 to 30 sites. Sites will be in North America, Australia, Israel, and the European Union. There might be other countries as well.

    at UCLA

  • DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

    open to eligible people ages 18 years and up

    The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-over-expressing and/or HER2-mutated advanced NSCLC subjects.

    at UCSD

  • DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

    open to eligible people ages 18 years and up

    The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

    at UCLA

  • DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

    open to eligible people ages 18 years and up

    This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body

    at UCLA

  • DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

    open to eligible people ages 18 years and up

    This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

    at UCLA UCSF

  • Experimental Treatment With "Carvedilol" to Avoid Heart Problems in Patients With HER-2-Positive Breast Cancer That Has Spread

    “This study will test whether carvedilol can reduce heart problems during your cancer treatment.”

    open to eligible people ages 18 years and up

    This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.

    at UC Davis

  • FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

    open to eligible people ages 18 years and up

    FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in subjects with advanced solid tumors.

    at UCSD

  • HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

    open to eligible people ages 18 years and up

    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.

    at UCSF

  • Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted

    open to eligible females ages 18 years and up

    This phase I trial studies talimogene laherparepvec given together with ipilimumab and nivolumab before surgery in patients with triple-negative or estrogen receptor positive, HER2 negative localized breast cancer. Ipilimumab and Nivolumab are immune checkpoint inhibitors that enhance immune response towards cancer cells. Talimogene laherparepvec is a modifies human herpes virus 1 that is an oncolytic virus targeting cancer cells and makes tumor microenvironment more immunogenic to promote immune response against cancer. This study will assess the safety and efficacy of talimogene laherparepvec, ipilimumab, and nivolumab, and provide an insight for further improvement of immunotherapy in breast cancer.

    at UCLA

  • Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

    open to eligible people ages 18 years and up

    Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study. The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

    at UCSD

  • Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

    open to eligible people ages 18 years and up

    The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

    at UC Irvine UCLA

  • PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

    open to eligible people ages 18 years and up

    The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer

    at UCLA

  • Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

    open to eligible people ages 18 years and up

    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) .

    at UC Davis UCLA

  • PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

    open to eligible people ages 18 years and up

    A Phase 1b, open-label, dose escalation study of PRS-343 in combination with atezolizumab in patients with HER2-positive advanced or metastatic solid tumors.

    at UCLA

  • PRS-343 in HER2-Positive Solid Tumors

    open to eligible people ages 18 years and up

    A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.

    at UCLA

  • Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)

    open to eligible people ages 18 years and up

    This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

    at UCLA UCSF

  • Study of MT-5111 in HER2-positive Solid Tumors

    open to eligible people ages 18 years and up

    This will be a Phase 1, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) in subjects with HER2-positive solid tumors.

    at UCLA

  • Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions

    open to eligible people ages 18 years and up

    Open-label, Phase 2, single treatment arm, 3 cohorts

    at UC Irvine

  • SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

    open to eligible females ages 18 years and up

    The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

    at UCSD

  • Talimogene Laherparepvec With Paclitaxel or Endocrine Therapy in Treating Participants With Metastatic, Unresectable, or Recurrent HER2- Negative Breast Cancer

    open to eligible people ages 18 years and up

    This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with paclitaxel or endocrine therapy in treating participants with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body, cannot be removed by surgery, or has come back after. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. 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. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with paclitaxel or endocrine therapy may work better in treating participants with HER2-negative breast cancer.

    at UCSF

  • The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

    open to eligible people ages 18 years and up

    This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: - Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) - Group B: Trastuzumab + Vinorelbine + Avelumab - Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)

    at UCSF

  • Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

    open to eligible people ages 18 years and up

    This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body

    at UCLA UCSF

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