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Clinical Trials

Breast

Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.

Status: Accepting New Patients
Principal Investigator: Raizer

A Pilot Study of Time Restricted Diet in Obese/Overweight Pre & Postmenopausal Women

The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer.

Status: Accepting New Patients
Principal Investigator: Khan

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal

The study will help doctors determine if treatment with drugs called enzalutamide and exemestane taken together is better at slowing the growth of breast cancer than treatment with exemestane alone. This study is also being done to test whether these 2 drugs can be given together safely to women with your type of breast cancer.

Status: Accepting New Patients
Principal Investigator: Gradishar

A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative Breast Cancer

The study will help doctors decide if enzalutamide may be a potential treatment for women with breast cancer, including triple-negative breast cancer, which expresses the androgen receptor. This study is also being done to test the safety and tolerability of enzalutamide, meaning, how taking enzalutamide may affect a patient's health or make her feel.

Status: Accepting New Patients
Principal Investigator: Gradishar

Improving Quality of Life among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG Cancer Navigation Services Program

The purpose of this study is to compare patient navigation with or without the addition of LIVESTRONG navigation services.

Status: Accepting New Patients
Principal Investigator: Penedo

A Pilot Phase II Trial of Cabergoline in the Treatment of Metastatic Breast Cancer

The purpose of this study is to evaluate the effectiveness of cabergoline in treating metastatic breast cancer disease in those who test positive for the prolactin receptor.

Status: Accepting New Patients
Principal Investigator: Kaklamani

Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 3 - MEK162 for Patients with RAS/RAF/MEK Activated Tumors Local

The purpose of this clinical trial is to study if MEK162 is safe and has beneficial effects in people who have different tumor types (cancer), and/or blood malignancies with a RAS/RAF/MEK activated pathway. This pathway is thought to play a role in tumor cell growth as well as in the growth of new blood vessels, which supply the tumor with nutrients and oxygen.

Status: Accepting New Patients
Principal Investigator: Johnson

An Open-Label, Phase II, Single-Arm Study of Everolimus in Combination with Letrozole in the Treatment of Postmenopausal Women with Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer

The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially available.

Status: Accepting New Patients
Principal Investigator: Gradishar

A Phase II, Open-Label, Multi-Center Study of ANG1005 in HER2+ Breast Cancer Patients with Progressive/Recurrent Brain Metastases

The main purpose of this research study is to find out if the study drug, ANG1005 can shrink tumor cells that have spread to the brain. Another purpose of this study is to evaluate the safety, effectiveness and how ANG1005 is being tolerated by patients with brain metastases.

Status: Accepting New Patients
Principal Investigator: Kumthekar

Targeted eHealth Intervention to Reduce Fear of Recurrence (FoR) Among Cancer Survivors: FoRtitude

The purpose of this study is to create a web-based application titled FoRtitude that teaches breast cancer survivors how to reduce their fear of cancer recurrence.

Status: Accepting New Patients
Principal Investigator: Wagner

Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women with Stage 0-II Primary Breast Cancer: PACT-B (Progesterone Antagonists for Cancer Treatment for Breast) Study

The purpose of this study is to determine whether or not the medication that blocks the effects of the hormone progesterone (CDB-4124 or Proellex) will decrease the growth rate of breast cancer cells as compared to a placebo.

Status: Accepting New Patients
Principal Investigator: Khan

A Phase I Study of BYL719 and Trastuzumab-MCC-DM1 in HER2-Positive Metastatic Breast Cancer Patients with Progression on Prior Trastuzumab and Taxane-Based Therapy

The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer.

Status: Accepting New Patients
Principal Investigator: Jain

Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 4 - LGX818 for Patients with BRAFC600 Mutated Tumors

Researchers want to know if LGX818 is safe and has beneficial effects in people who have different tumor types (cancer), and/or blood malignancies with a BRAFV600 activated pathway. This pathway is thought to play a role in tumor cell growth as well as in the growth of new blood vessels, which supply the tumor with nutrients and oxygen.

Status: Accepting New Patients
Principal Investigator: Johnson

Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 2 - Dovitinib for Patients with Tumor Pathway Activations Inhibited by Dovitinib Including Tumors with Mutations or Translocations of FGFR, PDGFR, VEGF, CKIT, FLT3, CSFR1, TRK and RET

Researchers want to know if dovitinib (TKI258) is safe and has beneficial effects in people who have different tumor types (cancer) and/or blood malignancies whose disease progressed after standard treatment.

Status: Accepting New Patients
Principal Investigator: Johnson

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumor and Lymphoma Malignancies

Two of the main purposes of this study are to determine the side effects and risks of TAK-659 and the highest dose of TAK-659 that can be given to patients daily without causing side effects and risks that are too severe.

Status: Accepting New Patients
Principal Investigator: Petrich

Extended Duration Varenicline for Smoking among Cancer Patients: A Clinical Trial

The main purpose of this research study is to compare 12 versus 24 weeks of varenicline treatment, also known as Chantix®, for smoking cessation.

Status: Accepting New Patients
Principal Investigator: Hitsman

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

The main purpose of this clinical trial is to study patients with positive nodes before chemotherapy who become negative after chemotherapy to see1) if, after lumpectomy (surgery to remove cancer), radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping cancer from returning, and 2) if, after mastectomy (surgery to remove part or all of one or both breasts), radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping cancer from returning.

Status: Accepting New Patients
Principal Investigator: Donnelly

Randomized phase II trial of trastuzumab or EVEROLIMUS in hormone-refractory metastatic breast cancer

The purpose of this study is to investigate if trastuzumab or everolimus is effective for breast cancers that are no longer controlled with (resistant to) hormonal therapies, and have small to moderate amounts of HER2/neu.

Status: Accepting New Patients
Principal Investigator: Kaklamani

A Phase II Trial of Bevacizumab in Patients with Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy

The purpose of this study is to see what effect bevacizumab, the drug being tested, will have on brain disease from solid tumor cancers. This study will not evaluate the effect of bevacizumab on the systemic solid tumor cancer.

Status: Accepting New Patients
Principal Investigator: Kumthekar

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The main purpose of the study is to determine if patients with the BRCA1 or BRCA2 mutation and metastatic breast cancer do better with veliparib in combination with temozolomide or carboplatin and paclitaxel with or without veliparib.

Status: Accepting New Patients
Principal Investigator: Gradishar

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

There are 2 parts to this study (phase II and phase III). The part of the study in which a participant is enrolled depends on the timing of starting in the study. The purpose of the phase II part of the study is to treat the cancer that has spread to a participant's spine, and is causing pain, with image-guided radiosurgery/SBRT. The purpose of phase III is to compare the effects, good and/or bad, of image-guided radiosurgery/SBRT to standard radiation therapy to find out which treatment provides the most rapid pain relief with the least side effects.

Status: Accepting New Patients
Principal Investigator: Kalapurakal

Phase I Safety Study of Intratumoral Injection of Clostridium novyi-NT Spores in Patients with Treatment-Refractory Solid Tumor Malignancies

This study is being done to learn whether the study drug, Clostridium novyi-NT spores (NT refers to non-toxin producing), is safe and effective in patients with advanced cancers that can no longer be controlled with standard therapy or cancers for which there is no standard effective treatment.

Status: Accepting New Patients
Principal Investigator: Jain

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

The purpose of this study is to determine if a natural compound derived from flaxseed (Brevail) can reduce breast cell growth in premenopausal women. Also, to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles.

Status: Accepting New Patients
Principal Investigator: Khan

SWOG 1207: Phase-III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study - evaluating everolimus with endocrine therapy

The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.

Status: Accepting New Patients
Principal Investigator: Jain

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.

Status: Accepting New Patients
Principal Investigator: Donnelly

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes,Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less

The purpose of this study is to find out if the Oncotype DX Recurrence Score can help decide whether patients should receive chemotherapy or not.

Status: Accepting New Patients
Principal Investigator: Gradishar

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in the breast to the standard approach of continued treatment with the medication.

Status: Accepting New Patients
Principal Investigator: Khan

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