Clinical trials: HER2 Positive Breast Carcinoma
Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma
Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer
This is a single-center, open-label, randomized phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant Culmerciclib combined with aromatase inhibitor versus aromatase-inhibitor monotherapy in patients…
- Conditions
- Hormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma, Early-Stage Breast Cancer
- Trial name
- NCT07796880
- Testing
- Culmerciclib, Aromatase Inhibitor (AI)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer
Fasting on Newly Diagnosed Breast Cancer
This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of…
- Trial name
- STEFNE (NCT02379585)
- Testing
- Doxorubicin, cyclophosphamide, paclitaxel
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Western Regional Medical Center
Early-stage Breast Cancer, HER2 Positive Breast Cancer
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus…
- Conditions
- Early-stage Breast Cancer, HER2 Positive Breast Cancer, Hormone Receptor Positive
- Trial name
- DIANER (NCT05252988)
- Testing
- Neratinib, Loperamide, Colesevelam
- Where
- 55 sites in Spain
- Volunteers
- 177 people
- Sponsor
- Spanish Breast Cancer Research Group
Metastatic Breast Cancer, HER2 Negative Primary Tumor
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab …
- Trial name
- NCT01975142
- Testing
- Trastuzumab - Emtansine
- Where
- 10 sites in France
- Volunteers
- 155 people
- Sponsor
- Institut Curie
Advanced Breast Cancer
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative…
- Trial name
- NCT06656624
- Testing
- Ribociclib combined with AI±OFS, physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS
- Where
- China
- Volunteers
- 190 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
HR-positive,HER2-negative in Advanced Breast Cancer
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen…
- Trial name
- NCT05375461
- Testing
- TQB3616 capsules, Fluvestrin injection
- Where
- 2 sites in China
- Volunteers
- 293 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HER2 Positive Breast Cancer, Left Ventricular Function Systolic Dysfunction
Cardiac Safety Study in Patients With HER2 + Breast Cancer
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer.
- Trial name
- SAFE-HEaRt (NCT01904903)
- Testing
- Trastuzumab, Pertuzumab, Ado Trastuzumab Emtansine
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Medstar Health Research Institute
Breast Neoplasms
Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer
This is a real world study to evaluate the efficacy and safety of inetetamb combined with pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab progression in HER2-positive metastatic breast cancer.
- Trial name
- NCT05764941
- Testing
- Inetetamab, Pyrotinib, Vinorelbine
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, ER Positive Breast Cancer
Role of the Immune Environment in Response to Therapy in Breast Cancer
This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers.
- Conditions
- Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
- Trial name
- NCT05396612
- Testing
- Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Fludzoparib" and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast Cancer
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets.
- Trial name
- NCT06255392
- Testing
- Fluzoparib, Apatinib Mesylate, Capecitabine tablets
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors, HER2-positive Breast Cancer
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in participants with HER2-positive advanced solid tumors with or without…
- Trial name
- NCT05593094
- Testing
- ZN-A-1041, ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b, ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 210 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of…
- Trial name
- NCT03062007
- Testing
- BI-CON-02
- Where
- 6 sites in Russia
- Volunteers
- 6 people
- Sponsor
- Biointegrator LLC
Metastatic Breast Cancer
A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
- Trial name
- NCT07071337
- Testing
- SKB264, Nab-paclitaxel, Paclitaxel
- Where
- 2 sites in China
- Volunteers
- 430 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Stage IV (Metastatic) Breast Cancer
A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors
SoGreat is an open-label, single-arm, modular, two-stage, Phase Ib/II study. SoGreat (Part 1) is an open-label, modular, Phase Ib study.
- Trial name
- SoGreat (NCT07163481)
- Testing
- Sacituzumab Govitecan + Fulvestrant, Sacituzumab Govitecan + Anastrozole / Exemestane
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Hunan Cancer Hospital
Breast Cancer
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of…
- Trial name
- NCT04460911
- Where
- United States
- Volunteers
- 317 people
- Sponsor
- Pfizer
ErbB2-Positive Stage I-III Breast Cancer
Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic erbB2-positive breast cancer.
- Trial name
- NCT01309607
- Testing
- paclitaxel/carboplatin/lapatinib
- Where
- Singapore
- Volunteers
- 34 people
- Sponsor
- National University Hospital, Singapore
Breast Cancer, Gastric Cancer
IKS014 in Advanced Solid Tumors That Express HER2
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate…
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- Trial name
- NCT05872295
- Testing
- IKS014
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 165 people
- Sponsor
- Iksuda Therapeutics Ltd.
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors
This phase Ib trial studies the side effects and best dose of ALRN-6924 when given together with paclitaxel in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery.
- Conditions
- Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT03725436
- Testing
- MDM2/MDMX Inhibitor ALRN-6924, Paclitaxel
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- M.D. Anderson Cancer Center
Carcinoma, Ductal, Breast
Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer
The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer.
- Trial name
- NCT01891357
- Testing
- Biopsy before and after three weeks of study treatment, paclitaxel, lapatinib
- Where
- 10 sites in Germany
- Volunteers
- 64 people
- Sponsor
- Women's Cancer Study Group GmbH
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