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NCT ID: NCT05228210 Terminated - Breast Cancer Clinical Trials

Breast Cancer Self-Efficacy Scale for Partners

BCSES-P
Start date: September 1, 2019
Phase:
Study type: Observational

The concept of self-efficacy is a major predictor of physical, psychological, social and overall quality of life (QoL) among breast cancer survivors (BCS). Because survivor and partner outcomes are often linked, it is reasonable to hypothesize that self-efficacy is an important predictor of physical, psychological, social and overall QoL in partners as well. However, this hypothesis has yet to be tested, in part because no scale exists to measure cancer-related self-efficacy in partners. Development and psychometric testing of such a scale is a critical first step in developing a theoretical model predicting QoL in this population. Partners of BCS often report lower QoL compared to partners of healthy women, making them an important focus of research. During the award period, the applicant will follow standard instrument development procedures to develop the Breast Cancer Self-Efficacy Scale for Partners (BCSES-P) and test the scale's psychometric properties using a large and diverse sample of partners of breast cancer survivors.

NCT ID: NCT05128773 Terminated - Breast Cancer Clinical Trials

Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

AMEERA-6
Start date: February 17, 2022
Phase: Phase 3
Study type: Interventional

This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The primary objective was to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival. The treatment duration per participant was to be 5 years, followed with a subsequent 5-years follow-up period. For the treatment period, visits were scheduled at the start of treatment, then at 4 weeks and 12 weeks after treatment start, and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5. For the follow-up period, visits were scheduled 30 days after last treatment and then every 12 months. Three periods were planned: - A screening period of up to 28 days, - A treatment period of up to 5 years, - A follow-up period of up to 5 years.

NCT ID: NCT05080842 Terminated - Breast Cancer Clinical Trials

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer

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

This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: - Identify the recommended dose of AC682 that can be given safely to participants - To evaluate the side effects of AC682 - To evaluate pharmacokinetics of AC682 - To evaluate the effectiveness of AC682

NCT ID: NCT05063604 Terminated - Breast Cancer Clinical Trials

Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression

CAMAD
Start date: May 10, 2022
Phase: Phase 2
Study type: Interventional

To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.

NCT ID: NCT05013554 Terminated - Breast Cancer Clinical Trials

Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

Start date: August 16, 2021
Phase: Phase 1
Study type: Interventional

Primary Objectives: Part 1 (Dose Escalation) - To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part. - To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration. Part 2 (Dose expansion) • To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Secondary Objectives: Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Part 2 • To determine the safety of SAR443216. Part 1 and 2 - To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration. - To evaluate the immunogenicity of SAR443216 after IV and SC administration. - To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.

NCT ID: NCT05012397 Terminated - Gastric Cancer Clinical Trials

Milademetan in Advanced/Metastatic Solid Tumors

Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

Phase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that exhibit wild-type (WT) TP53 and MDM2 copy number (CN) ≥ 8 using prespecified biomarker criteria.

NCT ID: NCT04995575 Terminated - Breast Cancer Clinical Trials

Dissecting the Pathways of Therapy Resistance in Early Breast Cancer

MINDACTRelapse
Start date: July 8, 2020
Phase:
Study type: Observational

Within the 1st step MINDACT patients who have already relapsed will be asked to participate. For these patients a biopsy of the metastasis should have been taken. A molecular analysis of the stored primary tumor sample and of the metastatic sample, using new technologies, will be performed, and the characteristics of both samples will be compared. Within the 2nd step a prospective collection of the metastasis samples will be implemented and analysis of biological material from relapsing MINDACT patients is foreseen. This process will provide insights on the biology of breast cancer and allow us to better understand mechanisms of resistance to therapies, contributing to overcoming this important problem.

NCT ID: NCT04950010 Terminated - Breast Cancer Clinical Trials

High-intensity Exercise After Treatment

HEAT
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).

NCT ID: NCT04947917 Terminated - Breast Cancer Clinical Trials

Axillary Lymph Node Tattoo Marking Study

Start date: December 29, 2021
Phase: N/A
Study type: Interventional

This research study investigates if SpotTM ink can help breast surgeons retrieve sampled lymph node as well as or better than the standard clip and radioseed guidance methods. The names of the novel study intervention involved in this study is: - SpotTM ink tattooing The names of the standard of care study interventions involved in this study are: - Core needle biopsy and/or fine needle aspiration - Surgical Removal of the Lymph Nodes via clip and radioseed guidance

NCT ID: NCT04936451 Terminated - Breast Cancer Clinical Trials

Electrotherapy in the Management of Myofascial Syndrome

MODYMYO
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Myofascial syndrome is defined as "musculoskeletal pain characterized by local and referred pain perceived to be deep and constant, and by the presence of myofascial trigger points in any part of the body" Post-breast surgery myofascial syndrome affects up to 44.7% of operated women, mainly on the muscles of the greater shoulder girdle. The repercussions are significant, functional, somatic, psychological and socio-professional affecting the quality of life. The treatments offered may or may not be medicinal. Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists of a battery-powered device that delivers electrical impulses through electrodes placed on the surface of your skin. The electrodes are placed at or near nerves where the pain is located or at trigger points.