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Breast Neoplasms clinical trials

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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: NCT05103826 Terminated - Clinical trials for ER+ / HER2- Advanced Breast Cancer

A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer

Start date: October 25, 2021
Phase: Phase 1
Study type: Interventional

The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.

NCT ID: NCT05085002 Terminated - Clinical trials for Advanced Breast Cancer

A Study of Lerociclib in Participants With Advanced Breast Cancer

Start date: December 21, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, single-arm, open-label study to evaluate the safety and efficacy of lerociclib in combination with standard endocrine therapy in female or male participants with HR+/HER2- MBC. The study population will consist of either newly diagnosed, treatment naïve participants with HR+/HER2- MBC (1L population) and participants with HR+/HER2- MBC who have already progressed on first line endocrine therapy such as tamoxifen, anastrozole, or letrozole (2L population). All premenopausal or perimenopausal female participants, and all male participants, must be receiving goserelin for at least 28 days prior to entering the study and will remain on goserelin throughout the study, in accordance with the prescribing information and according to the study site's standard practice.

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: NCT05067972 Terminated - Breast Neoplasms Clinical Trials

A Study of PF-07260437 in Advanced or Metastatic Solid Tumors

C4431001
Start date: October 7, 2021
Phase: Phase 1
Study type: Interventional

A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.

NCT ID: NCT05065411 Terminated - Clinical trials for Metastatic Breast Cancer

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

VERU-024
Start date: April 11, 2022
Phase: Phase 3
Study type: Interventional

STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)]. STAGE 2: To demonstrate the efficacy and safety of enobosarm 9 mg QD in combination with abemaciclib 150 mg BID (Enobosarm Combination Group) versus Estrogen Blocking Agent (Control Treatment Group) in the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), androgen receptor positive (AR+) with a AR% nuclei staining ≥40% metastatic breast cancer that have previously experienced disease progression on an estrogen blocking agent plus (palbociclib) as measured by progression free survival (PFS) according to RECIST 1.1 criteria.

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: 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