Clinical trials: Disorders of Breast
Breast Cancer, Breast Neoplasms
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT03556358
- Testing
- TX05 (trastuzumab), Herceptin®, Paclitaxel
- Where
- 146 sites in Belarus, Chile and 8 more
- Volunteers
- 809 people
- Sponsor
- Tanvex BioPharma USA, Inc.
Head and Neck Cancer, Malignant Melanoma
GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors
The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or…
- Conditions
- Head and Neck Cancer, Malignant Melanoma, Colorectal Cancer, Renal Cell Carcinoma
- Trial name
- NCT06265025
- Testing
- GM103 (Part A), GM103 (Part B), GM103 and Pembrolizumab (Part C)
- Where
- 4 sites in South Korea
- Volunteers
- 125 people
- Sponsor
- GeneMedicine Co., Ltd.
Breast Cancer, Pancreatic Cancer
Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
This study is a Phase I, first in human, dose-escalation study of MORAb-066, an investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets TF-expressing malignancies that include breast, pancreatic…
- Conditions
- Breast Cancer, Pancreatic Cancer, Colorectal Cancer, Carcinoma, Non-Small-Cell Lung
- Trial name
- NCT01761240
- Testing
- MORAb-066
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Morphotek
FGFR Inhibition, Pharmacokinetics, Biomarkers, ER+ Breast Cancer
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
- Trial name
- GLOW (NCT01202591)
- Testing
- AZD4547, Exemestane, Fulvestrant
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
Breast Cancer, Lung Cancer
Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors
The purpose of this study is to test the combination of an experimental drug known as MGCD0103 given along with an FDA-approved drug called docetaxel.
- Conditions
- Breast Cancer, Lung Cancer, Pulmonary Cancer, Non-Small-Cell Lung Carcinoma
- Trial name
- NCT00511576
- Testing
- MGCD0103 & Docetaxel
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Mirati Therapeutics Inc.
Breast Neoplasms, Neoplasms, Hormone-dependent
Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug…
- Trial name
- NCT00044291
- Testing
- atamestane, toremifene, letrozole
- Where
- 63 sites in United States, Canada and 2 more
- Volunteers
- 865 people
- Sponsor
- Intarcia Therapeutics
Metastatic Breast Cancer
Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for HER2-negative metastatic breast…
- Trial name
- NCT02651610
- Testing
- Bavituximab, Taxane
- Where
- 2 sites in United States
- Sponsor
- Peregrine Pharmaceuticals
Breast Cancer
Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Explore the relationship between drug target ER gene single nucleotide polymorphisms and Raloxifene therapeutic effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.
- Trial name
- Drugs-SNPs (NCT06062810)
- Testing
- Raloxifene - Usual, Raloxifene - Study
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Neoplasms, Breast
Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China
Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib + capecitabine in women with Human epidermal growth factor receptor 2 (HER2) positive advanced or metastatic breast cancer.
- Trial name
- NCT00508274
- Testing
- lapatinib, capecitabine
- Where
- 11 sites in China, Hong Kong
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasm
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast…
- Trial name
- NCT00251095
- Testing
- Taxol, TOCOSOL Paclitaxel
- Where
- 14 sites in United States
- Volunteers
- 821 people
- Sponsor
- Achieve Life Sciences
Triple Negative Breast Cancer
to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as…
- Trial name
- NCT04301739
- Testing
- HLX10, nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide
- Volunteers
- 522 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Breast Cancer
Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer
The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL)…
- Trial name
- NCT00976365
- Testing
- THL-P
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Taiwan THL Co.LTd.
Progesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone Therapy
Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers
This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma.
- Trial name
- NCT02052128
- Testing
- onapristone
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Arno Therapeutics
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Amyotrophic Lateral Sclerosis (ALS), Angina, Stable
Quest to Analyze One Thousand Humans Meditating
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and…
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety, Asthma
- Trial name
- QUANTUM (NCT06583395)
- Testing
- Advanced multi-component meditation practice
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Tobias Moeller-Bertram
HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell…
- Conditions
- HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT01598077
- Testing
- LJM716
- Where
- 8 sites in United States, Canada and 3 more
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Breast Reconstruction After Mastectomy
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well…
- Trial name
- PRO-BRA (NCT01885572)
- Testing
- TiLOOP Bra
- Where
- 8 sites in Germany
- Volunteers
- 267 people
- Sponsor
- Pfm Medical Mepro Gmbh
Malignant Neoplasm of Breast
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
- Trial name
- NCT03366428
- Testing
- DS-8201a
- Where
- 7 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Metastatic Breast Cancer
An Early Phase Study of Abraxane Combined With Phenelzine Sulfate in Patients With Metastatic or Advanced Breast Cancer
This phase 1b study will determine the safety and efficacy of combined treatment of Abraxane and phenelzine sulfate (Nardil) for metastatic or locally advanced breast cancer.
- Trial name
- Epi-PRIMED (NCT03505528)
- Testing
- Nanoparticle albumin-bound paclitaxel, Phenelzine Sulfate
- Where
- 3 sites in Australia
- Volunteers
- 8 people
- Sponsor
- EpiAxis Therapeutics
Advanced Solid Tumor, Metastatic Cancer
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the…
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT04464967
- Testing
- SNK01, Trastuzumab, Cetuximab
- Sponsor
- NKGen Biotech, Inc.
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