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Breast Neoplasms clinical trials

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NCT ID: NCT01532960 Terminated - Breast Cancer Clinical Trials

Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer

Breast 41
Start date: July 2012
Phase: Phase 1
Study type: Interventional

Despite advances in surgical, radiation and medical therapies of early stage breast cancer, some patients will experience disease recurrence. Because recurrence may not happen for years after definitive treatment, there is a period of time between resection and relapse when micrometastatic disease may be amenable to immune eradication or modulation. While the ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast immunotherapy is to define treatments that have immunologic efficacy. In this study, the investigators will determine whether a vaccine consisting of nine-class I breast specific peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.

NCT ID: NCT01532232 Terminated - Breast Cancer Clinical Trials

Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

Start date: February 2012
Phase: N/A
Study type: Observational

Breast cancer patients who smoke, are at greater risk for treatment complications. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients.

NCT ID: NCT01531764 Terminated - Clinical trials for Carcinoma Breast Stage IV

BIBW 2992 (Afatinib) and Vinorelbine

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

This open-label, single-arm, multicentre phase II trial will be performed in patients with intermediate HER2-positive, metastatic breast cancer (MBC)pretreated with anthracyclines and one first-line therapy in the metastatic setting. The main objective of the trial is to evaluate the efficacy and safety of BIBW 2992 in combination with vinorelbine in patients with intermediate HER2-positive MBC. If this trial shows promising results, further studies to evaluate the benefit of BIBW 2992 in combination with chemotherapy in this subgroup of intermediate HER2-positive patients with MBC are warranted. Patients will be followed until progression. After progression, for the purpose of analysing overall survival, information on vital status and subsequent treatment will be collected. The primary objective is to determine the 6-month progression free survival rate of BIBW 2992 and vinorelbine i.v. in patients with metastatic, HER2 IHC 2+, HER2 FISH-negative breast cancer. BIBW 2992 in combination with vinorelbine will provide a suitable combination to test the hypothesis that patients with metastatic breast cancer whose tumours are HER2 2+ by immunohistochemistry, but negative by fluorescence in-situ hybridisation (FISH) will benefit from a combination of a cytotoxic agent, i.e. vinorelbine, plus the dual irreversible EGFR/HER2-tyrosine kinase inhibitor BIBW 2992.

NCT ID: NCT01522300 Terminated - Mammary Tumor Clinical Trials

Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search

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

The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

NCT ID: NCT01512199 Terminated - Clinical trials for Metastatic Breast Cancer

Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)

Start date: November 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects with metastatic breast cancer.

NCT ID: NCT01499160 Terminated - Breast Neoplasms Clinical Trials

Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

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

About a third of patients with breast cancer are usually treated by hormone pills called tamoxifen and aromatase inhibitors. Aromatase inhibitors are drugs that stop female hormone production. Female hormone or estrogen is an important hormone for the growth of breast cancer cells. Letrozole is one of the aromatase inhibitors that is approved by the FDA and has been used to treat breast cancer since 1997. However, hormone pills usually work for about 6-10 months in most patients. Later on, breast cancer will start to grow again. This condition when hormone pills or endocrine therapy no longer work is called "endocrine resistant" breast cancer. The scientists here at University of Maryland have discovered how these cancer cells can become resistant to hormone pills. In our laboratory tests, the investigators found that lapatinib and everolimus can reverse this resistance and make letrozole work again. However, it is not known if the drugs can reverse the resistance in humans. The purpose of this study is to find out whether the combination of letrozole, lapatinib, and everolimus is effective in women with breast cancer when hormone pills no longer work. Lapatinib is an anti-cancer drug that is already approved by the Food and Drug Administration (FDA). It is the standard of care for the treatment of a particular type of breast cancer called human epithelial growth factor receptor 2 (HER2)-positive breast cancer. HER2 is a protein involved in the growth of some cancer cells. This study will also include patients with HER2-negative breast cancer. This means that the cancer cells in these patients do not depend on the HER2 protein. The use of lapatinib in these patients is considered experimental. Everolimus is also an anti-cancer drug that is approved by the FDA for kidney cancer. Initial studies in mice and later studies in women with breast cancer have shown that everolimus may also slow the growth of breast cancer. The use of everolimus is experimental in this study.

NCT ID: NCT01498588 Terminated - Breast Cancer Clinical Trials

Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

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

Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow the patient to have less extensive surgery. The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of eribulin followed by doxorubicin and cyclophosphamide can shrink the size of the patient's breast tumor and allow you to preserve your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.

NCT ID: NCT01495247 Terminated - Clinical trials for Metastatic Breast Cancer (MBC)

Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

Start date: January 30, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.

NCT ID: NCT01484041 Terminated - Breast Cancer Clinical Trials

Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer

Start date: April 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This study is for women with confirmed hormone receptor positive HER-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to determine how well these medications work together and/or if they have any side effects in patients with hormone-receptor positive metastatic breast cancer who have demonstrated progression of disease after first line hormonal therapy. This research is being done to determine if taking an already approved medicine (aromatase inhibitor) in combination with a new medication (dovitinib) results in better outcomes for patients with this disease. Both dovitinib and an aromatase inhibitor are pills that will be taken at home.

NCT ID: NCT01479348 Terminated - Breast Neoplasms Clinical Trials

Imaging Study for FdCyd and THU Cancer Treatment

Start date: November 1, 2011
Phase: Early Phase 1
Study type: Interventional

Background: - The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: - To study how FdCyd affects advanced cancer cells. Eligibility: - Participants in National Cancer Institute study 09-C-0214. Design: - Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. - Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. - This procedure will be repeated at a later date, during the FdCyd and THU treatment period. - Treatment will not be provided as part of this study. This is an imaging study protocol only....