Clinical trials: Stage I Breast Cancer
- Condition Stage I Breast Cancer
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Breast Cancer
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and…
- Trial name
- NCT01111825
- Testing
- Temsirolimus, Neratinib
- Where
- 12 sites in United States, Denmark and 4 more
- Volunteers
- 99 people
- Sponsor
- Puma Biotechnology, Inc.
Progressive Metastatic Malignancies
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug.
- Trial name
- NCT00496860
- Testing
- ALT-801
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Altor BioScience
Metastatic Breast Cancer
Phase I Combination w/ Epirubicin
Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment.
- Trial name
- NCT00322374
- Testing
- Ixabepilone, Epirubicin
- Where
- 2 sites in France, Italy
- Volunteers
- 42 people
- Sponsor
- R-Pharm
Breast Cancer
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2…
- Trial name
- NCT03916744
- Testing
- Giredestrant, Surgery
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 75 people
- Sponsor
- Genentech, Inc.
Advanced Solid Tumors
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors.
- Trial name
- NCT02460224
- Testing
- LAG525, PDR001
- Where
- 24 sites in United States, Australia and 10 more
- Volunteers
- 490 people
- Sponsor
- Novartis Pharmaceuticals
Bone Pain in Stage I - III Breast Cancer
NOLAN: Naproxen or Loratadine and Neulasta
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic…
- Trial name
- NOLAN (NCT01712009)
- Testing
- Naproxen, Loratadine, Pegfilgrastim
- Where
- 83 sites in United States
- Volunteers
- 600 people
- Sponsor
- Amgen
Metastatic Breast Cancer, HER2+ Breast Cancer
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.
- Trial name
- NCT01132664
- Testing
- BKM120, Trastuzumab, Capecitabine
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax
The study will be a multi-center, prospective, randomized, single-blinded, placebo-controlled Phase II trial of Herceptin + NeuVax(TM) vaccine (E75 peptide/granulocyte macrophage-colony stimulating factor) (GM-CSF) versus…
- Trial name
- NCT01570036
- Testing
- Herceptin, NeuVax vaccine, GM-CSF
- Where
- 29 sites in United States
- Volunteers
- 275 people
- Sponsor
- George E. Peoples
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Healthy Participants
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.
- Trial name
- NCT05045638
- Testing
- Rosuvastatin, Sotorasib
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Breast Cancer
Post Market Study Using the Xoft Axxent System
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Trial name
- NCT01017549
- Testing
- Electronic brachytherapy (Axxent System)
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Xoft, Inc.
Advanced or Metastatic Breast Cancer, ER+ve Advanced or Metastatic Breast Cancer
Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients
The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer.
- Trial name
- BEECH (NCT01625286)
- Testing
- AZD5363 when combined with weekly paclitaxel., AZD5363when combined with weekly paclitaxel.
- Where
- 41 sites in Bulgaria, Canada and 9 more
- Volunteers
- 148 people
- Sponsor
- AstraZeneca
Breast Cancer, Gastric Cancer
A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)
This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design…
- Trial name
- TRAXHER2 (NCT01702558)
- Testing
- Capecitabine, Trastuzumab emtansine (T-DM1)
- Where
- 40 sites in Argentina, Brazil and 10 more
- Volunteers
- 182 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Assess the Pharmacokinetics and Safety of Different Forms and Formulations of AZD9496 in Healthy Subjects
This is a phase 1 open label single centre study of AZD9496 administered orally in healthy volunteers. The study design involves single administration of different forms, formulations and doses of AZD9496.
- Trial name
- PK (NCT02780713)
- Testing
- AZD9496 (Reference), AZD9496 Variant A, AZD9496 Variant B
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic…
- Trial name
- NCT00568022
- Testing
- Ixabepilone, Capecitabine
- Where
- 4 sites in Japan
- Volunteers
- 9 people
- Sponsor
- R-Pharm
Metastatic Cancer
Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer
During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type.
- Trial name
- MODULATE (NCT03009058)
- Testing
- IMM-101, Gemcitabine, Nab-paclitaxel
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 2 people
- Sponsor
- Immodulon Therapeutics Ltd
Ovarian, Breast
A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and…
- Conditions
- Ovarian, Breast, SCLC, Gastric Cancers
- Trial name
- MEDIOLA (NCT02734004)
- Testing
- Olaparib, MEDI4736, Bevacizumab
- Where
- 47 sites in United States, France and 5 more
- Volunteers
- 264 people
- Sponsor
- AstraZeneca
Breastcancer, Breast Neoplasm
SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions.
- Trial name
- NCT03066947
- Testing
- SV-BR-1-GM, Cyclophosphamide, Interferon-alpha-2b
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- BriaCell Therapeutics Corporation
HER2-normal
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
- Trial name
- NCT01328249
- Testing
- eribulin mesylate
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.