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Breast Neoplasms clinical trials

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NCT ID: NCT04824339 Recruiting - Breast Neoplasms Clinical Trials

Breast Cancer Endocrine Therapy FITness (BE-FIT) Trial.

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

This project will assess the efficacy of an 8-week virtual exercise program on physical function offered to those with a breast cancer diagnosis currently receiving endocrine therapy. The intervention includes twice-weekly virtual group exercise classes. Participants also complete one to three independent home exercise sessions per week throughout the intervention. Testing will occur virtually at baseline, 8-weeks (at end of program) and follow-up evaluations will be performed at 16-weeks and 12- months after baseline testing. Questionnaires will be administered through REDCap. Exercise sessions and testing will be administered virtually via Zoom.

NCT ID: NCT04824027 Recruiting - Breast Cancer Clinical Trials

Breast Elasticity Imaging During Neoadjuvant Chemotherapy

Start date: June 14, 2021
Phase: N/A
Study type: Interventional

For this study, the investigators propose investigation of a new imaging technique, Harmonic Motion Imaging (HMI), and the evaluation of its potential role in prediction of breast cancer response to neoadjuvant chemotherapy (NACT). The investigators hypothesize that changes in HMI parameters will predict response to neoadjuvant systemic therapy in early-stage breast cancer.

NCT ID: NCT04824014 Recruiting - ER+ Breast Cancer Clinical Trials

4FMFES-PET Imaging of ER+ Advanced Breast Cancers

Start date: November 1, 2020
Phase: Phase 2
Study type: Interventional

Estrogen Receptor (ER) is a crucial prognostic factor and treatment target in breast cancer patients. Knowledge of its status greatly influences the choice of the optimal course of treatment. Pathological evaluations of primary tumor, axillary nodes, and metastases are the only confirmatory approach to ER status determination and are limited to known and accessible sites. However, it is known that many advanced breast cancer patients harbor diseases presenting inter-tumor or temporal ER heterogeneity, as ER expression can vary between tumor foci and can evolve during treatment and at time of recurrence, hence the need for whole-body, non-invasive assessment of ER status. In the last decades, 16α-[18F]fluoroestradiol (FES) was developed and evaluated as an ER-targeting positron emission tomography (PET) tracer. FES correlated with ER expression, and recently was shown to be able to predict hormone therapy response. Our Center designed and evaluated 4-fluoro-11β-methoxy-16α-[18F]fluoroestradiol (4FMFES), a successor PET tracer for ER imaging. Paired comparison during a phase II clinical trial showed that 4FMFES produced images of better quality, with less overall non-specific signal than FES. It resulted in a significantly improved tumor contrast and tumor detectability using 4FMFES-PET leading to increased diagnosis confidence in early-stage breast cancer compared to FES-PET. Those results demonstrated that, as of now, 4FMFES-PET is the best imaging modality worldwide for whole-body ER status determination, but further validations are necessary to position this method as a standard and essential tool for breast cancer management. Like what was observed for FES-PET, preliminary data suggest that 4FMFES-PET combined with FDG-PET will yield very high sensibility for breast tumor detection, each method being complementary. In continuity with previous work, we seek to expand our clinical knowledge of this high-potential diagnostic imaging through the following main objective: Launch a phase II clinical trial to explore the full potential and benefit of 4FMFES-PET in combination with FDG-PET for advanced ER+ breast cancer patients to demonstrate it is an essential tool for cancer management. This proposed project will focus on 3 specific aims: 1. Compare and complement 4FMFES-PET with FDG-PET and conventional imaging modalities, and evaluate how they improved prognosis and staging of ER+ advanced breast cancer patients; 2. Correlate 4FMFES/FDG uptake and staging with pathological data (histology, receptor status, grade), including distal biopsy metastases sampling; 3. Correlate 4FMFES/FDG uptake and staging with longitudinal outcomes (treatment response, progression-free survival, time-to-relapse) to determine which cohort of patient benefit most from 4FMFES.

NCT ID: NCT04822597 Completed - Breast Cancer Clinical Trials

Pain Control for Breast Cancer Patients Receiving Injection of Radioactive Tracer

Start date: April 23, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness four different pain treatments for the injection of radioactive tracer that women with breast cancer receive for sentinel lymph node biopsies. This study will include women who have been diagnosed with breast cancer and who will be undergoing sentinel lymph node biopsy with a standard injection of radioactive tracer before surgery. A participant's active participation will take place on two separate occasions. In the first occasion, a participant will complete a brief pain assessment on the day of enrollment. The rest of a participant's active participation will take place on one day (the day of surgery) and last approximately 20 minutes, after which active participation will end.

NCT ID: NCT04821609 Recruiting - Breast Cancer Clinical Trials

Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema

STRONG-B
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training. This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.

NCT ID: NCT04821375 Active, not recruiting - Clinical trials for Increased Risk for Development of Breast Cancer

Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers

Start date: December 2, 2021
Phase: Early Phase 1
Study type: Interventional

Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters.

NCT ID: NCT04821141 Recruiting - Breast Cancer Clinical Trials

Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

Start date: December 14, 2021
Phase: Phase 2
Study type: Interventional

Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.

NCT ID: NCT04819243 Not yet recruiting - Clinical trials for Premenopausal HR+/HER2- Metastatic Breast Cancer

PALbociclib Endocrine Therapy Followed by Talazo vs. Talazoz-Atezo Study

Young-PALETTA
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar 1st line treatment: GnRH agonist + Aromatase Inhibitor(AI) + Palbociclib 28 days after the last treatment of 1st line treatment, randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)

NCT ID: NCT04818996 Completed - Breast Cancer Clinical Trials

Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

Start date: October 22, 2019
Phase: N/A
Study type: Interventional

In this study, it was aimed to evaluate the effect of the Mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.

NCT ID: NCT04818632 Completed - Clinical trials for ER+, HER2-, Metastatic Breast Cancer

AZD9833 China PK Study

AZD9833
Start date: November 12, 2021
Phase: Phase 1
Study type: Interventional

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer