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Early Breast Cancer clinical trials

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NCT ID: NCT05217381 Completed - Clinical trials for Metastatic Breast Cancer

Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status

RosHER
Start date: February 22, 2022
Phase:
Study type: Observational

This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).

NCT ID: NCT05213403 Completed - Early Breast Cancer Clinical Trials

Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

BreastNESSy
Start date: January 1, 2016
Phase:
Study type: Observational

Our aim is to create a Scoring System (SS) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing NACT. Secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating: - Loco-regional disease free-survival (LR-DFS): months between start of NACT and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla. - Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases. - Overall survival (OS): months from the start of NACT to death or last follow-up.

NCT ID: NCT04436744 Completed - Early Breast Cancer Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)

Start date: September 4, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment).

NCT ID: NCT04222790 Completed - Early Breast Cancer Clinical Trials

A Study of Monosialic Gangliosides to Prevent Albumin-bound Paclitaxel Neurotoxicity

Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

Taxane-induced peripheral neuropathy (TIPN) caused by paclitaxel is a dose-limiting toxicity. The main symptoms of discomfort are numbness, tingling, and burning sensations in the glove-sock-like distribution of the limbs. At present, there are few effective methods for clinical treatment of TIPN, and there is no widely agreed consensus on effective treatment in the world. Therefore, it is of great clinical significance and practical value to carry out clinical research to explore drugs to relieve TIPN.

NCT ID: NCT04137744 Completed - Early Breast Cancer Clinical Trials

Axillary Reverse Mapping Using Methylene Blue Subcutaneous Injection Can Identify Arm Lymph Nodes and Vessels, Measuring Arm Size for Lymphedema, Histopathological Examination of Arm Lymph Nodes Included With Axillary Lymph Node Dissection

Start date: February 2015
Phase: N/A
Study type: Interventional

study patients; axillary node negative breast cancer female, 74 patients randomly allocated in two groups each 37 patients , group I , where axillary reverse mapping(ARM) +ve nodes were preserved and axillary lymph node dissection completed.and group II where axillary reverse mapping +ve nodes were taken with axillary lymph node dissection(ALND) primary outcome is histopathological examination of a ARM +ve lymph nodes and volume measurements of the ipsilateral arm for development of lymphedema at 6 ,12 , and 24 months

NCT ID: NCT03786198 Completed - Early Breast Cancer Clinical Trials

Activity Program During Aromatase Inhibitor Therapy

Start date: March 28, 2019
Phase: N/A
Study type: Interventional

The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.

NCT ID: NCT03493854 Completed - Early Breast Cancer Clinical Trials

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

FeDeriCa
Start date: June 14, 2018
Phase: Phase 3
Study type: Interventional

This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

NCT ID: NCT02738970 Completed - Early Breast Cancer Clinical Trials

A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)

Start date: June 23, 2016
Phase: Phase 1
Study type: Interventional

This study involves a two-part design. Part 1 is designed to determine the optimal dose of subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be compared using a compilation of pharmacokinetic (PK) parameters such as area under the concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm the dosing regimen in women with EBC on the basis of safety, tolerability, and PK assessments.

NCT ID: NCT02187744 Completed - Early Breast Cancer Clinical Trials

A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

Start date: September 23, 2014
Phase: Phase 3
Study type: Interventional

The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in combination with Taxotere® and Carboplatin (Paraplatin) in patients with operable HER2 positive, breast cancer in the neoadjuvant setting. The hypothesis to be tested in this study is the percentage of patients with steady state Cycle 5 Ctrough (Cycle 6 pre-dose) >20 µg/mL of trastuzumab-Pfizer is similar to EU-approved trastuzumab, using a margin of -12.5%.

NCT ID: NCT01613352 Completed - Early Breast Cancer Clinical Trials

Feasibility of Ambulatory Surgery for Early Breast Cancer

Start date: March 2008
Phase: N/A
Study type: Interventional

The aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.