25 studies found

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

I-SPY will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a...

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R)...

A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread

The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple,...

Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

Eligible patients will be enrolled to the treatment arm based on breast cancer subtype. Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic...

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation. No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and Radiation therapy Oncology Group (RTOG) (NSABP B-39 and RTOG 0413)...

DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer

Surveillance population and ctDNA screening (up to 1000 patients): Clinically high risk, stage II-III, ER positive, HER2-, breast cancer patients who are currently receiving adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen are eligible for ctDNA screening if they meet any one of the following criteria for high risk...

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer...

Photohandler

A Phase II trial of sEphB4-HSA in combination with Anti PD1 Antibody Pembrolizumab (MK-3475) for metastatic urothelial cancer refractory to platinum

Patients with the most common type of bladder cancer are initially treated with chemotherapy with regimens that include a platinum agent such as cisplatin or carboplatin. Once the cancer develops resistance the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as pembrolizumab or nivolumab. This study proposes...

A Dose-escalation, Expansion Study of ARX788, in Advanced Solid Tumors Subjects With HER2 Expression (ACE-Pan Tumor 01)

Phase 1a will determine the recommended Phase 2 dose (RP2D) in subjects with advanced cancer whose HER2 test results are in situ hybridization (ISH) positive or immunohistochemistry (IHC) 3+, based on safety, tolerability, PK findings and antitumor activity. Phase 1b will assess the safety, tolerability, and PK and anticancer activity...

Health Literacy in Understanding Radiation Therapy Information in Patients Undergoing Definitive Radiation Therapy

PRIMARY OBJECTIVE: I. To assess patient health literacy and understanding of critical radiation information during consultation in Spanish and English speaking patient in the department of radiation oncology at Los Angeles County (LAC) + University of Southern California (USC) utilizing a patient survey administered after consultation. SECONDARY OBJECTIVE: I. Correlate...

Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy

This is a prospective, international, multi-center, observational study with a goal of collecting de-identified samples and data from 1,200 women with a known pelvic mass. Participants will consent to baseline and follow-up data and biospecimen collections.

Study of GNX102 in Patients With Advanced Solid Tumors

GNX102 is a humanized monoclonal antibody (mAb) developed by GlycoNex. GNX102 binds with high affinity to branched Lewis B/Lewis Y (LeB/LeY) glycans, which are novel glycans caused by glycosylation changes in tumors. The monomeric LeB and LeY are blood group related antigens, commonly present in healthy adult tissues at low...

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic...

A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6

INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. (Nonclinical safety studies showed no findings...

Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

PRIMARY OBJECTIVE: I. To compare invasive disease-free survival (IDFS) of patients with triple-negative (TNBC) or low estrogen receptor (ER)-positive and/or HER2 borderline breast cancer who have >= 1 cm residual invasive breast cancer and/or positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) after neoadjuvant chemotherapy randomized to receive 1 year of...

Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer

PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer. II. To evaluate the compliance with a controlled diet intervention. III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF...

Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

PRIMARY OBJECTIVES: I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical...

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

PRIMARY OBJECTIVES: I. To determine if 3-year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2-positive breast cancer who achieve pathologic complete response (pCR) (ypT0/is ypN0) after preoperative therapy with 12 weeks of a taxane, trastuzumab (or Food and Drug Administration [FDA] approved...

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with...

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy

PRIMARY OBJECTIVE: I. To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive sentinel lymph...

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention...

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

PRIMARY OBJECTIVES: I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. II. To evaluate the overall response rate (ORR) in patients with gestational trophoblastic tumors treated with...

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

PRIMARY OBJECTIVES: I. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. SECONDARY OBJECTIVES: I. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity. II. To evaluate the local and local...

Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

PRIMARY OBJECTIVE: I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. SECONDARY...

Core Biopsies for Establishing a Breast Tumor Tissue Repository

PRIMARY OBJECTIVES: I. To develop a baseline and serial breast cancer core biopsy repository within the University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer Program. II. To develop and maintain a secure clinical database of relevant demographic, clinical, pathologic and longitudinal outcome characteristics of the samples to be...