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Breast Neoplasms clinical trials

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NCT ID: NCT01451632 Completed - Colorectal Cancer Clinical Trials

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers

Start date: October 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.

NCT ID: NCT01451580 Recruiting - Clinical trials for Metastatic Breast Cancer

Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer

Start date: September 2005
Phase: Phase 2
Study type: Interventional

To determine the overall objective response rate of pegylated liposomal doxorubicin (Lipo-Dox)combined with cyclophosphamide/5-FU as second-line treatment in patients with metastatic breast cancer.

NCT ID: NCT01450020 Active, not recruiting - Breast Cancer Clinical Trials

Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors

Start date: June 1, 2012
Phase: N/A
Study type: Interventional

This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors

NCT ID: NCT01448447 Completed - Breast Cancer Clinical Trials

Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®

Mammosite ML
Start date: December 2009
Phase: N/A
Study type: Interventional

This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS. Hypotheses: - For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates. - Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy. - Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.

NCT ID: NCT01447771 Terminated - Breast Neoplasms Clinical Trials

Decision Support for Women With Breast Cancer

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

Breast cancer is a common malignancy among women in the United States. There are a variety of treatment decisions that need to be made. This study has been developed after a review of the literature demonstrated that women with breast cancer are making decisions regarding complex therapy issues in a way that is not congruent with their decision-making control preference. Some patients want to be empowered with information so that they can actively participate in the decision making about their care; others want to rely on the recommendations made by the oncologist. This is important because patients who were not satisfied with their adjuvant treatment decision noted a negative effect on quality of life and self image. These patients had more difficulties with treatment side effects; including aches, hot flashes, pain, and mood alteration. In additions the Institute of Medicine recommended that patient centeredness be a key aim of health care organizations and that all patients be given the opportunity to exercise the degree of control they choose over health care decisions that affect them. It is hypothesized that women making decisions regarding adjuvant therapy who are supported to make decisions based on their preferred level of control will have positive psychological outcomes.

NCT ID: NCT01446185 Completed - Breast Cancer Clinical Trials

Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients

SWITCH
Start date: January 2011
Phase: N/A
Study type: Interventional

Primary objective: Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast cancer adjuvant population. The impact of Oncotype DX on treatment recommendations can be either a decrease in treatment intensity defined as a change in treatment recommendation from chemotherapy plus hormonal therapy to hormonal therapy alone or an increase in treatment intensity defined as a movement from hormonal therapy alone to the addition of chemotherapy to hormonal therapy. Patients with HR+, N- breast cancer currently represent around 70% of newly diagnosed breast cancers. These are usually good prognosis tumors. However, on the basis of classical clinical and pathological prognostic parameters and markers, the international consensus guidelines recommend treatment with hormone- and chemotherapy in 85-95% of the cases. Considering the natural disease history, such as documented by the EBCTCG meta-analysis, more than 50% of these patients are overtreated, which leads to unnecessary side effects and costs to the health system and to the society. Oncotype DX appears to be well adapted to therapeutic de-escalation as it targets HR+, N- patients and is performed on fixed paraffin embedded tissue (FPET). It is therefore best adapted to daily clinical practice as it does not necessitate any specific surgical procedure or tissue freezing. The prognostic and predictive value of Oncotype DX in ER+, N- patients has been validated on three large adjuvant randomized trials (NASBP B-14, NSABP B-20, and the ATAC study). The test has been commercially available in the USA since 2004, and is being used for more than 50% of the HR+ N- patients in this country. While Oncotype DX has been validated in the USA, it needs to be independently evaluated in France, in the context of the local treatment guidelines and habits, to provide data that are meaningful to the French health system and to the French medical community.

NCT ID: NCT01446159 Completed - Clinical trials for Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer

Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

Start date: June 13, 2011
Phase: Phase 2
Study type: Interventional

Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

NCT ID: NCT01446016 Completed - Breast Cancer Clinical Trials

Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT)

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

The major purpose of this research study is to better understand how therapy works on different patients. This study is being offered to patients with a diagnosis of advanced or metastatic breast cancer who have failed anthracycline based therapy. The investigators want to see the response of breast cancer cell when treated with Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel) or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).

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: NCT01445054 Terminated - Breast Cancer Clinical Trials

111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer

Start date: March 1, 2007
Phase: Early Phase 1
Study type: Interventional

Background: - Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. - An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. - Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin. Objectives: -To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not. Eligibility: -Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study. Design: - Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status. - Patients have a physical examination and review of medical records. - Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin. - Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin. - Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.