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Breast Neoplasms clinical trials

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NCT ID: NCT01304797 Active, not recruiting - Breast Cancer Clinical Trials

Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer

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

This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.

NCT ID: NCT01303679 Terminated - Clinical trials for First Line Metastatic Breast Cancer

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

Start date: June 2010
Phase: Phase 3
Study type: Interventional

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab. Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.

NCT ID: NCT01303419 Terminated - Breast Cancer Clinical Trials

Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Start date: April 2010
Phase: N/A
Study type: Interventional

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

NCT ID: NCT01302821 Withdrawn - Breast Cancer Clinical Trials

C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this research project is to create images of where and how the amino acid (the building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in the case of cancer and other diseases, Tryptophan is processed abnormally, and possible treatments for this abnormality are of great interest because of the potential to improve cancer care.

NCT ID: NCT01302379 Completed - Breast Neoplasms Clinical Trials

Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

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

This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.

NCT ID: NCT01302002 Withdrawn - Breast Cancer Clinical Trials

The Use of Metformin in Early Breast Cancer Patients Pre-Surgery

Start date: January 2011
Phase: Phase 0
Study type: Interventional

The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.

NCT ID: NCT01301911 Terminated - Breast Cancer Clinical Trials

Study of Cipatinib in Patients With HER2 Positive or Uncertain Advanced Breast Cancer

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

Cipatinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of cipatinib in patients with HER2 positive or uncertain advanced breast cancer: 1. To evaluate the safety and tolerability of cipatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) 2. To determine the pharmacokinetic profile of cipatinib and its metabolites 3. To assess preliminary antitumor activity 4. To determine preliminary regimen for phase II study 5. To determine the relation of expression of HER-1 and HER-2 to the antitumor activity.

NCT ID: NCT01301729 Completed - Breast Cancer Clinical Trials

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Patients With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment

Start date: March 2011
Phase: Phase 4
Study type: Interventional

This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastutumab) in combination with a taxane as first line therapy in patients with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Patients will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01301040 Terminated - Breast Cancer Clinical Trials

Early Cardiac Toxicity of Adjuvant CT in Elderly BC.

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

The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT. This study also will compare the serum biomarkers profile during and after the (neo) adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess whether brain PET-CT allows detecting regional functional impairment in patients receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate psychological state and burden of primary caregivers before and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the Framingham risk score for Hard Coronary Heart Disease (10-year risk).

NCT ID: NCT01300962 Completed - Clinical trials for Metastatic Breast Cancer

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

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

This phase I study has been designed to establish the safety, tolerability and maximum tolerated dose (MTD) of four separate regimens for patients with metastatic breast cancer: dose- escalating BKM120 when combined with capecitabine (Arm A), with capecitabine and trastuzumab (Arm C), or with capecitabine and lapatinib (Arm D) and dose- escalating BEZ235 when combined with capecitabine (Arm B).