Clinical trials: HER2-positive Breast Cancer
Metastatic Breast Cancer, ER Positive Breast Cancer
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor…
- Conditions
- Metastatic Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TIRESIAS (NCT04660435)
- Testing
- Thymidine kinase activity
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Sandro Pitigliani
Breast Cancer
Dose-confirmation Study of ASLAN001 Combined With Weekly Paclitaxel and Carboplatin in Advanced Solid Tumours, Followed by a Study in Patients With Stage I-III HER2 Positive Breast Cancer
The current standard of care for stage I-III HER2-positive breast cancer is adjuvant chemotherapy combined with 1 year of adjuvant trastuzumab.
- Trial name
- NCT02396108
- Testing
- Paclitaxel + Carboplatin + ASLAN001
- Where
- Singapore
- Volunteers
- 55 people
- Sponsor
- National University Hospital, Singapore
Breast Cancer
NSABP Biospecimen Discovery Project
This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA…
- Trial name
- NCT01850628
- Testing
- Paclitaxel, trastuzumab, pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- NSABP Foundation Inc
Breast Neoplasms, Malignant Neoplasm of Breast
Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer
This is a Phase I/II, open-label dose-escalation study designed to evaluate the maximum tolerated dose (MTD) and dose-limiting side effects of ibrutinib (560 or 840 or 420 mg daily oral dose), given in combination with…
- Trial name
- NCT03379428
- Testing
- Trastuzumab, Ibrutinib 560 mg, Ibrutinib 840 mg
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- US Oncology Research
HER2-positive Metastatic Breast Cancer
Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.
Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
- Trial name
- NCT05230810
- Testing
- Alpelisib, Tucatinib, Fulvestrant
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Criterium, Inc.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma
- Trial name
- NCT05464810
- Testing
- Letrozole, Simvastatin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory University
Breast Cancer, Breast Neoplasm
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when…
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive
- Trial name
- RESPONSE (NCT05020860)
- Testing
- Paclitaxel, Carboplatin, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 185 people
- Sponsor
- Baylor Breast Care Center
HER2-positive Breast Cancer, Neoplasms
Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer
Non-randomized, open label, translational research study in women with early HER2-positive invasive breast carcinoma eligible for neoadjuvant treatment.
- Conditions
- HER2-positive Breast Cancer, Neoplasms, Breast Cancer
- Trial name
- BiOnHER (NCT05912062)
- Testing
- Trastuzumab (neoadjuvant), Pertuzumab (neoadjuvant), Paclitaxel (neoadjuvant)
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- Institut Català d'Oncologia
Breast Cancer, Brain Metastases
Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer
This is an open-label, non-randomised, phase II study to evaluate the efficacy of neratinib in combination with SOC systemic therapy on CNS metastasis both as for secondary prevention (cohort 1), primary treatment (cohort 2) and…
- Trial name
- NeraBrain (NCT04856475)
- Testing
- Neratinib
- Sponsor
- Jules Bordet Institute
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer, Solid Tumors
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2).
- Trial name
- NCT05262400
- Testing
- PF-07220060 + PF-07104091 combination dose escalation, PF-07104091 + PF-07220060 + fulvestrant dose expansion, PF-07104091 + PF-07220060 + letrozole dose expansion
- Where
- 44 sites in United States, Argentina and 7 more
- Volunteers
- 235 people
- Sponsor
- Pfizer
Advanced Breast Cancer, Metastatic Breast Cancer
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
- Trial name
- DB-Guide (NCT07683754)
- Testing
- Trastuzumab deruxtecan, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
Pegylated Liposomal Doxorubicin Plus Albumin-Bound Paclitaxel and Trastuzumab in HER-2 Positive Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of pegylated liposomal doxorubicin（PLD）plus Albumin-Bound Paclitaxel and trastuzumab as neoadjuvant therapy in HER-2 positive breast cancer.
- Trial name
- NCT03994107
- Testing
- Pegylated Liposomal Doxorubicin, Albumin-bound paclitaxel, Trastuzumab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Peking Union Medical College
Breast Cancer Invasive
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2…
- Trial name
- CORINNE-PI (NCT05910398)
- Testing
- pyrotinib
- Where
- China
- Volunteers
- 488 people
- Sponsor
- RenJi Hospital
HER2-positive Breast Cancer
Omission of Radiation in Patients With Her-2 Positive Breast Cancer
The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.
- Trial name
- NCT03460067
- Testing
- Omission of Radiation
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Kansas Medical Center
Invasive Breast Cancer, HER2-positive Breast Cancer
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in…
- Conditions
- Invasive Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
- Trial name
- fREEDOM (NCT06328465)
- Testing
- Diffusion whole body MRI
- Where
- Italy
- Volunteers
- 145 people
- Sponsor
- European Institute of Oncology
Breast Cancer
Breast Cancer Study of Preoperative Pembrolizumab + Radiation
This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the…
- Trial name
- NCT03366844
- Testing
- Pembrolizumab, RT Boost
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Stephen Shiao
Breast Cancer
Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or…
- Trial name
- NCT00712881
- Testing
- Liposomal doxorubicin hydrochloride, Cyclophosphamide, Trastuzumab
- Where
- 22 sites in Austria, Belgium and 4 more
- Volunteers
- 126 people
- Sponsor
- Cephalon, Inc.
Early-Stage Breast Carcinoma, HER-2 Positive Breast Cancer
Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer
The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B).
- Trial name
- PREDIX HER2 (NCT02568839)
- Testing
- docetaxel + trastuzumab sc + pertuzumab, trastuzumab emtansin
- Where
- 7 sites in Sweden
- Volunteers
- 202 people
- Sponsor
- Thomas Hatschek
Metastatic Breast Cancer
Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors.
- Trial name
- NCT04963595
- Testing
- Pyrotinib, Vinorelbine, Inetetamab
- Volunteers
- 100 people
- Sponsor
- Zhiyong Yu
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