Clinical trials: High-risk Breast Cancer
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
Advanced Solid Tumors, Breast Cancer Recurrent
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity…
- Conditions
- Advanced Solid Tumors, Breast Cancer Recurrent, Ovarian Cancer, High-grade Serous Ovarian Carcinoma
- Trial name
- NCT06799065
- Testing
- ATX-295, ATX-295 and bevacizumab (or biosimilar)
- Where
- 11 sites in United States
- Volunteers
- 218 people
- Sponsor
- Accent Therapeutics
Oral Mucositis Due to Radiation, Radiation Dermatitis
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis…
- Trial name
- SafePBM (NCT03988556)
- Testing
- Photobiomodulation using CareMin650 at 6 Joules (curative intent), Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
- Where
- 5 sites in France
- Volunteers
- 72 people
- Sponsor
- NeoMedLight
Metastatic Breast Cancer
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase…
- Trial name
- NCT02753595
- Testing
- Eribulin mesylate, Biologic: PEGylated recombinant human hyaluronidase (PEGPH20), Biologic: PEGylated recombinant human hyaluronidase
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Eisai Inc.
NSCLC, SCLC
Study of Oral MRT-2359 in Selected Cancer Patients
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer…
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL
- Trial name
- NCT05546268
- Testing
- Oral MRT-2359
- Where
- 17 sites in United States
- Volunteers
- 174 people
- Sponsor
- Monte Rosa Therapeutics, Inc
Chemotherapy-induced Neutropenia
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing…
- Trial name
- NCT03559387
- Testing
- ANF-RHO™, Neulasta®
- Where
- 8 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Prolong Pharmaceuticals
Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Study to Investigate LYL797 in Adults With Solid Tumors
This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC)…
- Conditions
- Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Non-small Cell Lung Cancer, Non Small Cell Lung Cancer
- Trial name
- NCT05274451
- Testing
- LYL797
- Where
- 18 sites in United States
- Volunteers
- 57 people
- Sponsor
- Lyell Immunopharma, Inc.
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or…
- Conditions
- Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma, Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial
- Trial name
- NCT05544929
- Testing
- KFA115, pembrolizumab
- Where
- 18 sites in United States, Canada and 10 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative…
- Trial name
- monarchE (NCT03155997)
- Testing
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Where
- 619 sites in United States, Argentina and 36 more
- Volunteers
- 5,637 people
- Sponsor
- Eli Lilly and Company
Healthy, Breast Cancer
Validation of a Tear-based Screening Assay for Breast Cancer
This study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms.
- Conditions
- Healthy, Breast Cancer, Breast Cancer Female, Health Care Utilization
- Trial name
- NCT04928014
- Testing
- Schirmer Strip
- Where
- United States
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Namida Lab
Advanced Solid Tumor, Unresectable Solid Tumor
A Beta-only IL-2 ImmunoTherapY Study
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a…
- Conditions
- Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer
- Trial name
- ABILITY-1 (NCT05086692)
- Testing
- MDNA11, Pembrolizumab (KEYTRUDA®)
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Medicenna Therapeutics, Inc.
Breast Cancer
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
- Trial name
- OlympiA (NCT02032823)
- Testing
- Olaparib
- Where
- 698 sites in United States, Argentina and 22 more
- Volunteers
- 1,837 people
- Sponsor
- AstraZeneca
Breast Fibroadenoma
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient).
- Trial name
- NCT03742401
- Testing
- Surgery, HIFU (Echopulse)
- Where
- 12 sites in France
- Volunteers
- 2 people
- Sponsor
- Theraclion
Triple Negative Breast Cancer
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC
The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H…
- Trial name
- NCT03562637
- Testing
- adagloxad simolenin combined with OBI-821, Globo H IHC Assay, Standard of care treatment
- Where
- 128 sites in United States, Australia and 11 more
- Volunteers
- 575 people
- Sponsor
- OBI Pharma, Inc
Early Hormone Receptor-positive Breast Cancer
Clinical High and Genomic Low Hormone Receptor-positive Early Breast Cancer Patients With or Without Adjuvant Chemotherapy
A prospective, randomized, comparative study to evaluate efficacy of anticancer chemotherapy in predicting prognosis and determining chemotherapy method in early Hormone Receptor-positive breast cancer patients with…
- Trial name
- NCT04278469
- Testing
- Chemotherapy Drugs, Cancer
- Where
- South Korea
- Volunteers
- 194 people
- Sponsor
- Gencurix, Inc.
Breast Cancer
Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients
This will be a multi-center, prospective, randomized, single-blinded, placebo-controlled phase II trial of trastuzumab + nelipepimut-S/GM-CSF versus trastuzumab + GM-CSF alone.
- Trial name
- HER3+ (NCT02297698)
- Testing
- NeuVax vaccine, Trastuzumab, GM-CSF
- Where
- 24 sites in United States
- Volunteers
- 100 people
- Sponsor
- Cancer Insight, LLC
Chemotherapy-Induced Neutropenia, Breast Cancer
Evaluation of Maxy-G34 in Breast Cancer Patients Treated With TAC (Docetaxel, Adriamycin, Cyclophosphamide) Chemotherapy
This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six…
- Trial name
- NCT00501332
- Testing
- Maxy-G34
- Where
- 15 sites in Poland, Romania and 2 more
- Volunteers
- 30 people
- Sponsor
- Maxygen Holdings Ltd.
Cancer Harboring BRAF Alterations, HGG
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive…
- Conditions
- Cancer Harboring BRAF Alterations, HGG, LGG, Solid Tumors
- Trial name
- NCT05503797
- Testing
- Plixorafenib
- Where
- 70 sites in United States, Australia and 10 more
- Volunteers
- 254 people
- Sponsor
- Fore Biotherapeutics
Neoplasms, Cancer
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early.
- Trial name
- NCT03085888
- Where
- 35 sites in United States
- Volunteers
- 99,481 people, healthy volunteers welcome
- Sponsor
- GRAIL, Inc.
Breast Cancer
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group.
- Trial name
- NCT00152191
- Testing
- UFT (uracil, tegafur), cyclophosphamide, methotrexate, and fluorouracil
- Where
- Japan
- Volunteers
- 1,300 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.