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Breast Cancer clinical trials

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NCT ID: NCT01445418 Completed - Breast Cancer Clinical Trials

AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer

Start date: May 12, 2008
Phase: Phase 1
Study type: Interventional

Background: - Carboplatin is approved by the Food and Drug Administration to treat cancer. - AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that process. Objectives: - To determine the optimum doses of AZD2281 and carboplatin that can safely be used in patients with breast and ovarian cancer. - To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment. Eligibility: -Patients 18 years of age or older with breast or ovarian cancer who have a family history of cancer or who have a BRCA1 or BRCA2 mutation. Design: - In this dose escalation study, the first small group of patients receives the smallest study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher doses of first AZD2281 and then carboplatin as long as the preceding group has not experienced unacceptable side effects. When the highest safe dose is determined, additional patients receive that dose. - Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue until it is no longer beneficial. - Evaluations during treatment include the following: - Physical examination 1 week after starting treatment and then every 3 weeks. - Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks. - CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the tumor.

NCT ID: NCT01444456 Completed - Breast Cancer Clinical Trials

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Start date: October 2011
Phase: N/A
Study type: Observational

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia. Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

NCT ID: NCT01441011 Completed - Breast Cancer Clinical Trials

Rural Women Connecting for Better Health

Start date: August 2011
Phase: N/A
Study type: Interventional

Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.

NCT ID: NCT01440855 Completed - Breast Cancer Clinical Trials

Evaluation of the Efficacy of National Cancer Institute's Facing Forward Booklet in the Cancer Community Setting

Start date: February 2005
Phase: N/A
Study type: Interventional

This study was designed to provide a preliminary evaluation of the efficacy and usability of the 2004 revised version of the booklet, Facing Forward , Life After Cancer Treatment, (hereafter,Facing Forward) published by the National Cancer Institute. Facing Forward provides early stage cancer patients during the period after completing active treatment practical ways of dealing with common problems, including guidelines for managing physical, social, and emotional health. Assessments were completed at the patient's final cancer treatment visit. Follow-up assessments occurred eight weeks and 6 months later. The initial assessments covered background information (demographics, medical status), use of educational materials, survivorship activities, and psychological factors. The follow-up assessments included use of actions recommended in Facing Forward, ratings of Facing Forward with respect the booklet's informativeness, helpfulness, understandability, and extent read, the same psychological measures used initially, and a measure of self-efficacy.

NCT ID: NCT01440010 Completed - Breast Cancer Clinical Trials

TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

TARGIT_BQR
Start date: September 1, 2011
Phase:
Study type: Observational

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

NCT ID: NCT01439945 Completed - Breast Cancer Clinical Trials

Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

Start date: September 2011
Phase: Phase 2
Study type: Interventional

RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of breast cancer. PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.

NCT ID: NCT01439711 Completed - Breast Cancer Clinical Trials

Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

Start date: February 2012
Phase: Phase 2
Study type: Interventional

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.

NCT ID: NCT01439282 Completed - Breast Cancer Clinical Trials

Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.

NCT ID: NCT01437566 Completed - Breast Cancer Clinical Trials

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.

NCT ID: NCT01437007 Completed - Clinical trials for Colorectal Cancer With Hepatic Metastases

TKM 080301 for Primary or Secondary Liver Cancer

Start date: August 26, 2011
Phase: Phase 1
Study type: Interventional

Background: Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumors that can be removed by surgery live longer than those whose cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in the liver circulation, to see if it will cause tumors to shrink. Objectives: - To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have inoperable cancer that has started in or spread to the liver. Design: - Participants will be screened with a medical history and physical exam. They will also have blood tests, and imaging studies. - Participants will have a liver angiogram (type of X-ray study) to look at the blood flow in the liver and to place a catheter for delivery of the TKM080301. - Participants will have a single dose of TKM-080301 given directly into the liver. After the drug has been given, the catheter will be removed. They will have frequent blood tests and keep a diary to record side effects. - Participants may have two more doses, each dose given 2 weeks apart. {Before each dose, participants will have another angiogram and catheter placement.}They may also have liver biopsies to study the tumors. - Two weeks after the third treatment (one full course), participants will have a physical exam, blood tests, and imaging studies. If the tumor is shrinking, they may have up to three more courses of the study drug. - Participants will have follow up visits every 3 months for 2 years after the last course and then every 6 months as required.