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Studies
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Breast(19 Records found)
CTO#: 101504
Anus, Bones and Joints, Brain and Nervous System, Breast-Female
Status: Active/Enrolling
Sponsor: MUSC (101504)
A Phase I, Open-label, Dose-Escalation, Safety and Pharmacokinetic Study of ABC294640 in Patients with Advanced Solid Tumors
Lay Description: This study is for patients with solid tumor cancer for which there is no standard therapy available for the disease, or the disease has progressed (gotten worse) after the patient received standard therapy. This study has 2 parts. The purpose of Part I of this study is to examine the safety of the study drug and determine the safest amount of the study drug that can be given to patients who have any type of solid tumor cancer. The purpose of Part II of the study is to examine the safety and tolerable amount of ABC294640 in only patients with cancer of the pancreas. Patients on this study will receive study drug ABC294640 will be given orally (by mouth) twice a day (12 hours apart) continuously for 28 days. A cycle will be defined as 28 days. Whether the patient enrolls to Part I or Part II of the study, the patient will return to clinic for weekly assessments during Cycle 1. Regardless of which part of the study the patient was enrolled in, the patient may continue to receive therapy with the study drug until the disease gets worse, the patient has side effects that require the patient to stop taking the study drug, or the patient decides they no longer wish to take the study drug.
HIPAA
Informed Consent
Investigator's Brochure
Protocol
...details...
CTO#: 101568
Breast-Female
Status: Active/Enrolling
Sponsor: NSABP (B-47)
A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemo Alone (Six Cycles of Docetaxel Plus Cyclophosphamdide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemo Plus Trastuzumab in Women with Node-Positive or High Risk Node-Negative HER2-Low Invasive Breast Cancer
Lay Description: This study is for patients who have early stage breast cancer that has been removed by surgery. The purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning. Patients on this study will receive one of two combinations and schedules of chemotherapy drugs (either chemotherapy A or B). Arm 1, the patient will receive the chemotherapy that the patient and the doctor chose. The patient will not receive trastuzumab. Arm 2, the patient will receive the chemotherapy the patient and the doctor chose and the patient will also receive trastuzumab. It is expected that patients will be on this study for 10 years. During that time, the chemotherapy will take about 4½ to 6 months, depending on the chemotherapy the patient is receiving and the treatment schedule. If the patient is in Group 2A or 2B, trastuzumab therapy will take about 1 year. After the patient completes their study therapy, the study doctor will ask the patient to visit the office for follow-up exams (as described above) for 10 years from the time the patient joined the study.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101583
Anus, Bones and Joints, Brain and Nervous System, Breast-Female
Status: Active/Enrolling
Sponsor: MUSC ()
Accruing Preliminary Data Towards Testing the Hypothesis That Manual Therapy (Therapeutic Massage) Ameliorates Signs, Symptoms and Quality of Life Issues Associated with Chemotherapy-Induced Peripheral Neuropathy
Lay Description: This study is for patients who have pain and discomfort in their feet, which was caused by taking certain cancer chemotherapy drugs. This condition is called “chemotherapy-induced peripheral neuropathy” (CIPN). Drugs that can cause it include "platins" and "taxanes".
The purpose of the study is to learn more about using therapeutic massage (also called “manual therapy”) to treat this condition. Current treatments for CIPN are not effective for everyone, and often have unpleasant side effects. We are hopeful that therapeutic massage will bring relief to patients with CIPN, without using medications, and that this relief will last long after treatment is completed. The purpose of this study is to see if therapeutic massage reduces symptoms and signs of CIPN, and improves quality of life. Another purpose is to see if therapeutic massage changes blood circulation in the feet, and if this is associated with improvement of CIPN.
In this research study, we will enroll a small number of volunteers with CIPN. These volunteers will receive either therapeutic massage (Treatment Group) or have their CIPN monitored but not receive any treatment (Monitoring Group). The results will help us to plan a larger study. The larger study will more clearly determine how effective therapeutic massage is for patients with CIPN, and how it works.
No Documents currently available
...details...
CTO#: 101618
Breast-Female
Status: Active/Enrolling
Sponsor: Genentech, Inc. (GDC4950g)
A Phase II, Double-Blind, Placebo-Controlled, Randomized Study of GDC-0941 OR GDC-0980 with Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy
Lay Description: This study is for patients with breast cancer that is positive for the estrogen receptor (ER) and negative for the human epidermal growth factor receptor 2 (HER2), and the disease worsened while receiving treatment with a class of drug (aromatase inhibitors) used to treat the disease that interferes with an enzyme which synthesizes estrogen. . The purpose of this study is to find out what effects, good and/or bad, two drugs called GDC-0941 and GDC-0980 have on the patient and the breast cancer when given in combination with another drug, called fulvestrant. Patients on this study will receive the study drugs until the cancer worsens or until the patient experience any side effects that cannot be tolerated and are believed to be caused by the study drugs. It is expected that the patient will be on this study until the doctor has determined that the cancer has progressed, until the study treatment becomes intolerable, or until the completion or termination of the study. Study treatment visits will last approximately 1-3 hours. After the patient is finished with the study treatment, the study doctor will ask the patient to visit the office for a treatment completion visit described above within 30 days after the last dose of study treatment.
HIPAA
Informed Consent for subjects randomized after 7.10.2012
Informed consent for subjects randomized before 7.10.2012
Optional Consent
Optional Part II Consent
Part II Consent
PreScreening Consent
Protocol
Spanish HIPAA
Spanish Informed Consent
Spanish Patient Materials
...details...
CTO#: 101622
Breast-Female
Status: Active/Enrolling
Sponsor: MUSC ()
Paclitaxel Induced Peripheral Neuropathy in Breast Cancer: Exploratory Study of the Role of Deoxysphingolipids
Lay Description: This is a study for patients with breast cancer and will be receiving standard doses of paclitaxel chemotherapy. . The purpose of this study is to determine if peripheral neuropathy ( a known side effect of paclitaxel chemotherapy) is related to changes in the sphingolipid metabolic pathway. Patients on this study will have a blood sample will be collected at the same time that samples are drawn for routine laboratory testing required for treatment with chemotherapy. The patients will also be asked to complete a 19 item questionnaire during therapy regarding symptoms of numbness, pain and tingling for hands, fingers, feet and toes. It is expected that patients will be on this study for 12 weeks. Questionnaires are expected to take approximately 20 minutes to complete.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101628
Breast-Female
Status: Active/Enrolling
Sponsor: SWOG (S1007)
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Postive Nodes, Hormone Receptor-Positive and HER2 negative Breast Cancer with Recurrence Score of 25 or Less
Lay Description: This study is for women with hormone-responsive breast cancer with 1-3 positive lymph nodes and the breast cancer has already been removed by surgery. The purpose of the study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not. This study is being done in patients with lower Recurrence Scores (25 or less). Patients on this study will receive endocrine therapy since their cancer has been shown to respond to such therapy. However, because we are not certain that chemotherapy is needed for women with low Recurrence Scores then we "randomize" one-half of the patients to chemotherapy and one-half to not receive chemotherapy. Patients will also have, a tissue sample from the breast cancer will be collected and sent for Oncotype DX® testing. It is expected that participants will be on this study for up to 10 years. Treatment will end when the patient has completed standard endocrine therapy; or if the cancer returns. We would like to keep track of patient health for 15 years after they start the study.
HIPAA
Informed Consent_Step 1
Informed Consent_Step 2
Protocol
...details...
CTO#: 101629
Breast-Female
Status: Active/Enrolling
Sponsor: RTOG (1005)
A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
Lay Description: This study is for patients who have breast cancer and underwent a lumpectomy to remove the cancer and have been recommended by their doctor to have radiation therapy to the breast. The purpose of this study is to compare radiation therapy given with a higher daily dose over 3 weeks with a boost given each day of radiation therapy compared with standard whole breast radiation followed by a boost given on separate days which extends over 6 to 6 ½ weeks. Patients on this study will receive radiation therapy to the breast and the area of the lumpectomy alone on a Monday through Friday basis. A daily radiation therapy treatment will take approximately 10 – 15 minutes. The total length of time for which the patient will receive radiation therapy will depend upon which arm they are placed into. The patient should be able to do most or all of their daily activities between treatments. It is expected that patients will be on the study for approximately 3 weeks to 6 ½ weeks to complete depending upon which group they are placed into. Follow-up visits will be scheduled at 1 month, then 6 months and then yearly from the end of radiation therapy.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101633
Breast-Female
Status: Active/Enrolling
Sponsor: ECOG (E2108)
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Lay Description: This study is for patients with a cancerous tumor in their breast that has also spread beyond their breast to one or more other places in their body. 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 which is working to control the tumor. Patients on this study will initially receive the medication for their breast cancer that the doctor recommends. This may include chemotherapy or anti-hormone pills, and will last a minimum of four months and a maximum of eight. At the end of four to eight months of anti-cancer medication the patient will be randomly assigned to one of the two groups. Depending on which group they are assigned to, they will either continue with the treatment that is working for the patient (the standard of care) or to surgery (and possibly radiation) for the tumor in the breast (the new approach). The exact surgical procedure and radiation plan will be recommended by the doctor, but is roughly the same type of breast treatment that is given to women whose breast cancer has not spread. If the patients are randomized to the breast treatment arm, the anti-cancer medication will be interrupted while the patient is undergoing surgery and radiation. If the patient is randomized to the standard treatment arm, they will not experience an interruption in the anti-cancer treatment, and they will receive surgery and/or radiation only if the tumor in the breast starts to grow and cause problems such as skin break-down, skin nodules, or pain. It is expected that the patient will be on this study for 4 months and each study visit will last approximately 1-2 hours.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101675
Breast-Female
Status: Active/Enrolling
Sponsor: Abbott Laboratories (M12-895)
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
Lay Description: This study is for patients who may be a carrier of the BRCA1 or BRCA2 mutation with metastatic breast cancer. The purpose of this 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 or without veliparib. Patients on this study will be randomly assigned (like flipping a coin) to one of three treatment groups. Patients will receive the same treatment for the entire study if they are randomized to receive veliparib or placebo (placebo is a dummy medication that looks like the real medication but has no active ingredients) and carboplatin and paclitaxel. The length of the study may not be the same for each person. The doctor will carefully watch the progress of the cancer and with the patient will decide when the patient should stop taking the study treatments.
Amendment_2 Protocol
HIPAA
Informed Consent
Optional Consent
Patient brochure
Patient Flyer
Patient print ad
Questionnaire 1
Questionnaire 2
TMZ Dosing Card
Veliparib ONLY Dosing Card
Veliparib-Placebo Dosing Card
...details...
CTO#: 101756
Breast-Female
Status: Active/Enrolling
Sponsor: Genentech (GO25632)
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Bevacizumab and associated Biomarkers in combination with Paclitaxel in Comparison with Paclitaxel plus Placebo as First-line Treatment of Patients with HER2 negative Metastatic Breast Cancer
Lay Description: This study is for patients with progressive metastatic breast cancer. The purpose of this study is to identify those patients who are most likely to benefit from treatment with bevacizumab by utilizing a simple blood test. Another purpose of this study is to further understand if bevacizumab, in combination with paclitaxel, may increase the time subjects with progressive metastatic breast cancer live, if the treatment delays the growth of tumor(s), and if the tumor(s) shrinks. This study will also look at the safety and effectiveness of bevacizumab. Patients on this study will receive treatment with either bevacizumab combined with paclitaxel or placebo combined with paclitaxel. It is expected that patients will be on this study for approximately 6 years. Patients will have approximately 8 study visits and will continue to return to clinic every 8 weeks until disease progression.
HIPAA
Informed Consent
Pregnant Partner HIPAA
Protocol
...details...
CTO#: 101761
Breast-Female
Status: Active/Enrolling
Sponsor: SWOG (S0812)
A Randomized Double-Blind Placebo-Controlled Biomarker Modulation
Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer, Phase IIB
Lay Description: This study is for patients with a risk of breast cancer greater than other women their age and is pre-menopausal. The purpose of this study is to to see if vitamin D affects breast tissue by reducing breast tissue thickness (the amount of glandular breast tissue compared to fat) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells. Also, we want to find out what effects on the breast and also side effects vitamin D has. Patients on this study will receive vitamin D3 (cholecalciferol) or the placebo. It is expected that patients will be on this study for one year.
HIPAA
Informed Consent
Optional Consent
Protocol
...details...
CTO#: 101800
Breast-Female
Status: Active/Enrolling
Sponsor: NSABP (B-49)
A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Lay Description: This study is for patients that have early stage breast cancer that has been removed by surgery. This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating the type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer. Participants will be in the study for 10 years. During that time, chemotherapy will take about
4½ to 6 months. After participants complete chemotherapy, the study will will require follow-up exams for 10 years from the time the participant joined the study.
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101813
Breast-Female
Status: Active/Enrolling
Sponsor: MUSC ()
Vitamin D3 (Vit D3) Supplementation and T cell Immunomodulation in Patients with Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
Lay Description: This study is for patients with newly diagnosed breast cancer that includes surgery as part of the standard cancer treatment. The purpose of this study is to find out the effects of Vitamin D3 on the body’s immune system during the treatment period for Stage I-II breast cancer. Patients on this study will receive Vitamin D. It is expected that patients on this study about 56 days, from the time of registration (or the time diagnosis and following surgery).
Drug Diary Week 1-4
Drug Diary Week 5-8
HIPAA
Informed Consent
Protocol
...details...
CTO#: 101839
Kidney, Other Male Genital, Other Urinary, Prostate
Status: Active/Enrolling
Sponsor: MUSC ()
Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients with Advanced Cancer
Lay Description: This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer. The term "phytochemicals" refers to a wide variety of compounds produced by plants. They are found in fruits, vegetables, beans, grains, and other plants. This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract. Subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes) will receive grape seed extract alone once or twice a day for 21 days. Then subjects will begin taking Vitamin D-3 at a fixed dose for 42 days. It is anticipated that this study may last approximately 65 days.
FACT-P Questionnaire
HIPAA
Informed Consent
Patient Diary_COHORT 1_D1-21
Patient Diary_COHORT 1_D22-63
Patient Diary_COHORT 2-4_D1-21
Patient Diary_COHORT 2-4_D22-63
Protocol
...details...
CTO#: 101847
Breast-Female
Status: Active/Enrolling
Sponsor: ACOSOG (11102)
Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Cancers (MIBC)
Lay Description: This study is for patients with Multiple Ipsilateral Breast Cancers (MIBC). The purpose of this study is to see if removing only the tissues from the 2 or 3 cancers in the breast (breast conservation surgery) in combination with radiation to the breast, instead of removing the entire breast (mastectomy) is safe in keeping the cancer from coming back in the breast. After surgery, patients on this study will receive either hormone treatment or chemotherapy. Patients will also receive Whole Breast Irradiation (WBI). It is expected that patients will be on this study for up to 5 years after the WBI is completed.
HIPAA
Informed Consent
Patient brochure
Protocol
...details...
CTO#: 101860
Status: Active/Enrolling
Sponsor: Celgene (CC-122-ST-001)
A Phase 1A/1B, Multi-Center, Open-Label, Dose Finding Study to Assess The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of The Pleiotropic Pathway Modifier CC-122 Administered Orally To Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma Or Multiple Myeloma
Lay Description: This study is for subjects that have cancer that has spread or that cannot be cured by surgery, drugs, or any other known treatments. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. CC-122 belongs to a new class of drugs called “PPMs.” These drugs affect how the immune system works, slow the growth of tumor cells and block blood vessel growth in tumors. Approximately 100 people will take part in this study. The goal of this study is to test the highest, and/or the near-highest tolerated dose level. It may be necessary to test more than one dose level. This study will take place in the United States and in countries in Europe. This study will take about 18 to 24 months to complete. This study is only open to certain types of cancer including: (1) locally advanced (including inflammatory) breast cancer (LABC), (2) hepatocellular carcinoma (HCC), (3) certain types of brain tumor called glioblastoma multiforme (GBM), (4) multiple myeloma (MM), and (5) diffuse large B-cell lymphoma (DLBCL).
Consent
HIPAA
Patient Diary
Protocol
...details...
CTO#: 101864
Status: Active/Enrolling
Sponsor: Genentech (ML28257)
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with HER2 Positive Metatastic Breast Cancer
Lay Description: This study is for subjects who have been diagnosed with HER2+metastatic breast cancer. This is an observational study and will follow the regular medical care and treatments given to subjects who have been diagnosed with HER2+ metastatic breast cancer. Subjects will not be asked to take an experimental drug or participate in any experimental procedures. The main purpose of this study is to collect information on how subjects who have metastatic breast cancer are treated, and how they respond to the various treatments for this disease. Because this is an observational study, your doctor will determine the best treatment for you.
After enrollment, each subject's doctor will provide information about the history of their metastatic breast cancer, results of tests done for their cancer, and past treatments they have received. Four times per year (every 3 months), each subject's doctor will provide Genentech with information about their ongoing breast cancer treatment, results of tests performed, response(s) to treatment, and any complications experienced. Subjects' doctors will continue to provide this information four times per year for 5 to 8 years from the time subjects are enrolled in this study.
To understand how subjects are feeling, they will be asked to complete several questionnaires at baseline and periodically throughout study participation, during site visits and remotely, to assess overall health status, activities of daily living, and if they have had any other health issues. Subjects will be enrolled in this study for 8 years. Also, depending on when subjects are enrolled during the 36 month enrollment period, subjects will be followed for 5 to 8 years.
HIPAA
Informed Consent
Patient Materials FACT-B Document
Patient Materials General QOL Document
Patient Materials Health Care Survey
Patient Materials MDASI MUSC
Patient Materials PNQ_A2
Patient Materials PROCTCAE
Patient Materials RSCL
Patient Materials WPAI
Patient Materials-AlopeciaPA Document
Working Protocol
...details...
CTO#: 101867
Status: In Approval Process
Sponsor: SWOG (S1207)
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
Lay Description:
No Documents currently available
...details...
CTO#: 101874
Breast-Female
Status: Active/Enrolling
Sponsor: RTOG (1119)
Phase II Randomized Study of Whole Brain Radiotherapy in Combination With Concurrent Lapatinib in Patients With Brain Metastastis From HER2-Positive Breast Cancer a Collaborative Study of RTOG and KROG
Lay Description: This study is for patients with HER2-positive breast cancer that has spread to the brain. The purpose of this study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT) on the patient and the patient’s cancer. Patients on this study will receive either lapatinib plus WBRT or WBRT alone. It is expected that patients will be on this study for 3 weeks. Patients in Arm B, will continue taking lapatinib for 3 more weeks after finishing WBRT. After patients have finished receiving treatment on either Arm A or Arm B, the study doctor will ask patients to visit the office for follow-up exams every 12 weeks for the rest of their life.
Consent
HIPAA
Protocol
...details...
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