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NCT ID: NCT03703557 Recruiting - Breast Cancer Clinical Trials

Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer

Start date: July 25, 2018
Phase: N/A
Study type: Interventional

To ascertain the possibilities to isolate the breast cancer olfactive signature.

NCT ID: NCT03702309 Recruiting - Breast Cancer Clinical Trials

Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Start date: August 3, 2017
Study type: Observational

The objective of this protocol is to develop an institution-wide liquid biopsy protocol that will establish a common process for collecting blood and corresponding archived tumor specimens for future research studies at the University Health Network's Princess Margaret Cancer Centre. Circulating cell-free nucleic acids (cfNA), including cell-free DNA (cfDNA) and cell-free RNA (cfRNA), are non-invasive, real-time biomarkers that can provide diagnostic and prognostic information before cancer diagnosis, during cancer treatment, and at disease progression. Cancer research scientists and clinicians at the Princess Margaret are interested in incorporating the collection of peripheral blood samples ("liquid biopsies") into research protocols as a means of non-invasively assessing tumor progression and response to treatment at multiple time points during a patient's course of disease.

NCT ID: NCT03688958 Recruiting - Breast Cancer Clinical Trials

Iodine Supplementation on Breast Cancer

Start date: March 15, 2005
Phase: Phase 2
Study type: Interventional

The trial investigates the effect of oral supplement of molecular iodine (I2) alone and in combination with 4 to 6 cycles of FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) treatment in woman diagnosticated with early (stage II) and advance (stage III) breast cancer, respectively. The study analyzes the clinical response [tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).

NCT ID: NCT03682744 Recruiting - Breast Cancer Clinical Trials

CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)

Start date: September 13, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.

NCT ID: NCT03677427 Recruiting - Breast Cancer Clinical Trials

Comparing 5 and 15 Fractions for Whole Breast Irradiation After Breast Conserving Surgery

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

Adjuvant radiotherapy after breast-conserving surgery for breast cancer reduces the risk of locoregional relapse and ensures better overall survival. In recent years it has been found that hypofractionation in which the number of radiation sessions is reduced with a higher dose per session offers advantages for breast irradiation. Randomized studies showed that moderate hypofraction regimens in 15 or 16 fractions have the same effect in tumor control and toxicity, although the total dose is lower than the traditional 50 Gy in 25 fractions. In a randomized study from the United Kingdom (START-B trial) even a better disease-free survival was seen with 15 sessions than with 25 sessions and the long-term side effects were also less with the short schedule. This project proposes a clinical trial with an accelerated radiotherapy schedule in 5 sessions. It is expected that the accelerated schedule of 5 sessions over 12 days will have a number of radiobiological benefits: since a higher dose per session is given over a shorter period of time, it is expected that tumor control and survival will be higher. By reducing the total treatment time, the total dose is reduced, which may result in fewer radiation-related side effects and thus improve the quality of life. Apart from these radiobiological benefits, the shorter radiotherapy program reduces the number of treatment days from 15 to 5. This is not only more comfortable for the patients, but also increases the treatment capacity of the radiotherapy department. This opens up a possibility for the use of more complex techniques with fewer side effects such as radiation in the prone position. This project includes a randomized study comparing the accelerated schedule in 5 sessions with a hypofraction schedule of 15 sessions in patients who are irradiated on the entire breast after breast-saving surgery. The primary endpoint is chest retraction (loss of volume) 2 years after radiotherapy.

NCT ID: NCT03676114 Recruiting - Breast Cancer Clinical Trials

Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery

Start date: September 20, 2018
Phase: Phase 4
Study type: Interventional

Breast cancer patients often have perioperative emotional disorders such as anxiety and depression, which can lead to poor quality of recovery.This study aims to determine whether ketamine could improve the quality of recovery in breast cancer patients. Meanwhile, it will show if ketamine could improve anxiety, depression, postoperative pain and fatigue.This trial also will bring great concerns on patients' mental health perioperatively and explore the measures to improve their quality of life.

NCT ID: NCT03674515 Recruiting - Breast Cancer Clinical Trials

Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer

Start date: December 15, 2017
Phase: N/A
Study type: Interventional

Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients

NCT ID: NCT03671330 Recruiting - Breast Cancer Clinical Trials

Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.

Start date: August 29, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, double-blind, placebo-controlled study involving premenopausal and postmenopausal Chinese women plus an open-label single arm of pharmacokinetic cohort of LEE011 in combination with Letrozole in Chinese postmenopausal women with HR+, HER2- negative advanced breast cancer. Three cohorts of patients will be enrolled: PK cohort, premenopausal cohort, and postmenopausal cohort.

NCT ID: NCT03669497 Recruiting - Breast Cancer Clinical Trials

Hypo-Fractionated Radiotherapy in Breast Cancer

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

This is a prospective interventional phase I/II study which will be done at Tata Medical Centre, Kolkata. Total 30 eligible female patients, ≥18 years of age, with locally advance invasive carcinoma of breast, not amenable to curative surgery of metastatic breast cancer, planned for palliative loco regional radiotherapy will be enrolled in the study amongst which patients with left sided breast cancer (at least 10) will be recruited to study the feasibility of voluntary breath hold technique for heart sparing. Once consented, all patients will have regional baseline PET-CT scan of breast and tissue biopsy along with blood sampling done before studying radiotherapy. Planning Ct scan will then be taken, with standard planning CT scan for right breast cancers with implementation voluntary breath hold technique for the left breast disease. All patients will be treated with hypo-fractionated radiotherapy with schedule of 26Gy on 5 Fractions over 1 week with 6Gy simultaneously integrated boost with incorporation of breath hold technique for left breast disease. All patients will be assessed weekly during course of radiotherapy. The toxicity will be assessed using CTCAE version 4 and LENT SOMA toxicity criteria and the impact of the hypo-fractionated breast radiotherapy schedule on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire will also be assessed during treatment and follow-ups tissue bio0psy will be taken after 2 hours of completion of 1 st and last fraction of radiotherapy and biobanked for future radiobiological tests. Response evaluation will be done clinically and by regional PET CT scan using PERSIST criteria in 3 months after completion of radiotherapy. After completion of treatment, patient will initially be followed up every month for 1 st three months thereby 3 monthly for 2 years and 6 monthly for next 3 years.

NCT ID: NCT03667716 Recruiting - Breast Cancer Clinical Trials

COM701 in Subjects With Advanced Solid Tumors

Start date: September 6, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with a programmed cell death protein 1 (PD-1) inhibitor.