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Breast Neoplasms clinical trials

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NCT ID: NCT03313908 Completed - Clinical trials for Breast Cancer Female

Radioguided Occult Lesion Localisation by Indocyanine Green

ROLL-1
Start date: October 17, 2017
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and their small size encourage the investigators for finding methods simpler and more efficient to treat them by breast-conserving surgery with acceptable cosmetic results. The pre-operative detection of the tumor lesion is currently carried out by two methods: the radioactive seed localization and guidewire technique. Each has its disadvantages: the guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid requires a specialized and complex organization around this radioactive product. Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in breast cancer and seems promising. In this study, investigators evaluate the feasibility and performance of indocyanine green fluorescence in non-palpable tumor detection in comparison with radioactive seed localization (ROLL) Secondary objectives are evaluate the feasibility of the location by the radiologist, feasibility of detection by the surgeon, study of the product and the probe.

NCT ID: NCT03312738 Completed - Clinical trials for Advanced Breast Cancer

A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor

BOLERO-5
Start date: September 15, 2017
Phase: Phase 2
Study type: Interventional

This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on letrozole or anastrozole.

NCT ID: NCT03308201 Completed - Breast Cancer Clinical Trials

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer

Start date: October 16, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated regimen). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with exemestane, and the safety of Hemay022 in combination with letrozole or fulvestrant. The research will be divided into two parts. In the first part, 15 to 24 subjects will be enrolled to determine the safety and tolerability of combining Hemay022 with exemestane in patients with HER2-positive advanced breast cancer. The second part will enroll about 24-36 other subjects with ER and HER2-positive advanced breast cancer to better determine the tolerability and preliminary efficacy of Hemay022.

NCT ID: NCT03307044 Completed - Breast Carcinoma Clinical Trials

Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

Start date: November 16, 2017
Phase: N/A
Study type: Interventional

This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.

NCT ID: NCT03306472 Completed - Breast Cancer Clinical Trials

A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer

PIONEER
Start date: July 20, 2017
Phase: Phase 2
Study type: Interventional

Around 75% of breast cancers are defined and driven by Oestrogen receptor alpha (ERα) transcriptional activity. Standard treatment is endocrine therapy however clinical outcomes vary considerably, and a proportion of women with early breast cancer driven by ERα transcriptional activity develop drug resistance, and relapse with incurable, metastatic disease. Historically, PR-positivity was viewed as just a passive consequence of a functional oestrogen receptor, and PR was established as a biomarker of ER functionality in breast cancer. However, recent preclinical discoveries have provided an alternative explanation to the previous over-simplistic assumption, providing new insights into progestogen action and functional 'cross-talk' between ER and PR in breast cancer. In the presence of agonist ligands, progesterone-activated PR causes rapid sequestration of ERa chromatin binding sites in breast cancer cells, resulting in a unique gene expression program that is associated with a good clinical outcomes. This highlights a potential therapeutic opportunity. The PIONEER trial will investigate the effect of combining megestrol acetate (a progesterone receptor agonist) and letrozole (an aromatase inhibitor) in post menopausal women with early breast cancer. This is a 'window of opportunity' study treating and observing patients in the two weeks prior to definitive surgery. Patients are randomised into one of three arms; one in which the patients receive Letrozole alone; one in which they will receive a combination of Letrozole and low dose Megestrol acetate and the third arm will receive Letrozole and high dose Megestrol acetate. This trial will be open to postmenopausal women with newly diagnosed, untreated ER-positive, HER2-negative, invasive primary breast cancer.

NCT ID: NCT03304756 Completed - Clinical trials for Triple Negative Breast Cancer Patients

Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen

CAPneo
Start date: December 15, 2007
Phase: Phase 2
Study type: Interventional

This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days was further provided for 4 cycles. Primary outcome was pathological complete response in the breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and overall survival.

NCT ID: NCT03304587 Completed - Breast Cancer Clinical Trials

Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors

Start date: November 6, 2017
Phase: N/A
Study type: Interventional

This study will implement therapeutic bright light that is tailored to the individual's circadian typology and will estimate its effects on circadian rhythms, 4 common cancer-associated symptoms, and impact on quality of life in survivors living with cancer. Examining a selected phase marker (core body temperature) in relation to the associated clinical features (symptoms) is the starting point for future investigation of the biological mechanisms of symptoms.

NCT ID: NCT03304210 Completed - Clinical trials for Peritoneal Carcinomatosis

PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer

PIPAC-nabpac
Start date: September 16, 2017
Phase: Phase 1
Study type: Interventional

The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.

NCT ID: NCT03304171 Completed - Clinical trials for Invasive Breast Cancer

Overall Diet Quality and Breast Cancer Risk

Start date: October 1995
Phase: N/A
Study type: Observational

The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women.

NCT ID: NCT03304002 Completed - Breast Cancer Clinical Trials

Implementation of a Web-based Decision Aid for Breast Cancer Surgery

Start date: April 4, 2019
Phase:
Study type: Observational

Routine incorporation of decision aids into oncology practice has the potential to significantly improve patients' experiences with cancer by increasing the likelihood that they make informed treatment decisions aligned with their values. Unfortunately, only a minority of the more than 1.6 million patients diagnosed annually with cancer ever receive one due to limited clinic resources for administration and challenges in timely identification of appropriate patients. Online delivery directly to patients addresses some of these barriers but is insufficient on its own to ensure accessibility for patients at the time they most benefit from support.19 It is critical that active, multi-faceted implementation strategies that target barriers to the widespread use of web-based decision aids be identified, as these tools have the potential to significantly improve the quality of oncologic care. Based on strong preliminary work, the investigators have developed and piloted a package of implementation strategies that effectively overcomes barriers to delivery of a web-based breast cancer surgery decision aid in an academic and community clinic. Although the strategy was successful, patients were white and educated; further investigation is imperative in settings that provide care to underserved patients to ensure the intervention will mitigate, rather than worsen, existing disparities in breast cancer care. This is especially critical given that underserved patients may benefit most from shared decision-making interventions such as the one described. To study this, the investigators propose a pilot study within a clinic that serves a catchment area with a high proportion of African American, rural and low income patients. The investigators will iteratively assess and enhance our implementation package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient and clinic level barriers to implementation of a web-based breast cancer surgery decision aid in a clinic that cares for underserved patients, and 2) To test and expand our current implementation package's ability to address barriers in a clinic that cares for underserved patients. The investigators will determine the reach of implementation and acceptability of this method of decision aid delivery to stakeholders.