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Breast Neoplasms clinical trials

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NCT ID: NCT02688725 Active, not recruiting - Breast Cancer Clinical Trials

Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Start date: December 2014
Phase: N/A
Study type: Interventional

Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.

NCT ID: NCT02685332 Active, not recruiting - Clinical trials for Early Stage Breast Cancer

Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA

Start date: March 31, 2016
Phase: Phase 1
Study type: Interventional

Radiation, Stereotactic Body Radiation Therapy.

NCT ID: NCT02681562 Active, not recruiting - Breast Cancer Clinical Trials

Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients

Start date: January 2016
Phase: Phase 2
Study type: Interventional

Treatment selection for breast cancer is still largely empiric and guided by large randomized clinical trials on populations of patients. This approach is inadequate for the selection of individualized chemotherapy regimens. Estimates of benefits for individuals are extrapolations from the effects seen in these large trials, and do not necessarily apply to individual patients. The revolution in genomics promises to transform oncology care. By better defining cancer subtypes, a better understanding of breast cancer biology should help to guide treatment. The up-front phase we have decide to adopt play a pivotal role as it is useful for testing a targeted therapeutic drug such as olaparib wich also requires development of new biomarkers which may be useful for future studies. With this approach it could be possible to demonstrate drug target or biomarker effect in clinical setting and models the relationship between the pharmacodynamics and the pharmacokinetics. Additional benefits of this approach include the following: - It could facilitate rational drug selection, identify therapeutic failures early, and compress timelines for anticancer drug development. - It could provide initial rationale and guiding principles for further drug development based on studies in humans (rather than xenografts, where tissues of one species are transplanted to another species). - As it focuses on extensively characterizing how a drug works and whether it hits its intended target (including molecular imaging studies) in a limited number of patients it could yield results that would optimally inform and expedite the subsequent development of molecularly-targeted agents

NCT ID: NCT02676986 Active, not recruiting - Clinical trials for Primary Breast Cancer ER+ve

Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer

ARB
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Open-label, international, multicentre window of opportunity phase II trial to evaluate the effects of short-term preoperative therapy with enzalutamide (alone or in combination with exemestane) in women with newly diagnosed invasive primary breast cancer. The study has two cohorts: - ER+ve breast cancer - AR+ve, Triple-negative (i.e. ER-negative, PR-negative and HER2-negative) breast cancer Study treatment is planned for a minimum of 15 days and a maximum of 29 days unless there is evidence of unacceptable toxicity or the patient requests to be withdrawn from the trial. Thereafter, patients will either be considered for definitive surgery or primary medical treatment (e.g. neoadjuvant chemotherapy) at the discretion of the treating physician. The effects of enzalutamide (alone or in combination with exemestane) will be assessed on tumour tissue specimens taken at baseline and on the last day of study treatment.

NCT ID: NCT02668666 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Start date: June 30, 2016
Phase: Phase 2
Study type: Interventional

This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.

NCT ID: NCT02661932 Active, not recruiting - Breast Neoplasms Clinical Trials

Fertility Preservation in Breast Cancer Patients

Brovale
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.

NCT ID: NCT02654119 Active, not recruiting - Clinical trials for Stage IIB Breast Cancer AJCC v6 and v7

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery

Start date: December 11, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.

NCT ID: NCT02653755 Active, not recruiting - Clinical trials for Breast Cancer Radiation

The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this trial, we are attempting to identify which patients may not need radiation.

NCT ID: NCT02642458 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients

PerFECT
Start date: March 2016
Phase:
Study type: Observational

Despite the clear benefit of a combination therapy of pertuzumab plus trastuzumab plus docetaxel when compared with a combination therapy of trastuzumab and docetaxel the study populations of the CLEOPATRA trial might be slightly different from a patient population, in which pertuzumab, plus trastuzumab plus chemotherapy or trastuzumab plus chemotherapy are applied in routine clinical practice. This non-interventional approach aims to confirm the clinically relevant outcomes shown in the phase III CLEOPATRA study in patients with advanced HER2-positive breast cancer in routine practice. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician. Data on efficacy, safety, tolerability and quality of life will be documented for this purpose. Following the recommendations as laid down in guidelines for treatment of breast cancer, the quality of life of patients will be assessed on a regular basis.

NCT ID: NCT02642406 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Therapy Management With Nab-Paclitaxel in Daily Routine

SERAPHINA
Start date: December 2015
Phase:
Study type: Observational

Despite treatment improvements in breast cancer, a large number of patients still progress to the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable prognosis. Not only efficacy, but also quality of life are in the focus when planning a therapy or therapy sequence for metastatic breast cancer patients. Therapy options include anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One of the most effective chemotherapies in the adjuadjuvant and metastatic setting is paclitaxel. However drug handling and its side effects can compromise patients quality of life and can have an impact on the pharmacokinetics of the drug. In metastatic breast cancer patients increasing therapy efficacy and reduction of side effect frequency are considered to be advancements of therapy. One of these advancements is the development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane), which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is approved for the treatment of metastatic breast cancer after a failure of first-line therapy and when antracyclines are not indicated. The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and the frequency and perception of side effects. As a non-interventional study, the SERAPHINA Study will assess the patient characteristics and describe the patient cohort, in which nab-Paclitaxel is given. This includes age distribution and characteristics documented by the patients themselves.