Clinical trials: HER2-positive Breast Cancer
Breast Cancer, Brain Metastases
Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases
Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor…
- Conditions
- Breast Cancer, Brain Metastases, HER2-positive Breast Cancer
- Trial name
- NCT04582968
- Testing
- Pyrotinib Plus Capecitabine combined with brain radiotherapy
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Fudan University
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT03939897
- Testing
- Abemaciclib, Biopsy Procedure, Biospecimen Collection
- Where
- 14 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer
Level of HER2-neu Gene Amplification an Response to Trastuzumab
Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with…
- Trial name
- NCT00874146
- Testing
- Fluorescent in-situ hybridization (FISH)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Istituto Clinico Humanitas
Breast Cancer, Chemotherapy Effect
Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks
According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases.
- Trial name
- NCT05212454
- Testing
- Capecitabine
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Metastatic Breast Cancer, Advanced Breast Cancer
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and…
- Trial name
- ICARUS BREAST (NCT04965766)
- Testing
- U3-1402
- Where
- 11 sites in France
- Volunteers
- 139 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
HER2-positive Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.
- Trial name
- BREnnA (NCT07413939)
- Testing
- RO7771950, Tucatinib, Trastuzumab
- Where
- 206 sites in United States, Argentina and 23 more
- Volunteers
- 650 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Early-stage Breast Cancer
Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer
The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer.
- Trial name
- DEFINITIVE (NCT06446882)
- Testing
- Personalized treatment according to molecular diagnosis with HER2DX, Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
- Where
- 29 sites in Austria, France and 3 more
- Volunteers
- 304 people
- Sponsor
- Fundacio Clinic Barcelona
Breast Cancer, Breast Neoplasms
Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic…
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Tumors, Cancer
- Trial name
- NCT00807859
- Testing
- AMG 386 30 mg/kg, Paclitaxel and Trastuzumab, AMG 386 30 mg/kg, Capecitabine and Lapatinib, AMG 386 10 mgkg, Paclitaxel and Trastuzumab
- Where
- 23 sites in United States, Belgium and 1 more
- Volunteers
- 65 people
- Sponsor
- Amgen
HER2-Positive Breast Cancer
TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer
This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant…
- Trial name
- NCT04094896
- Testing
- TCHP
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Guangdong Provincial People's Hospital
HER2-positive Breast Cancer, ER-Negative Breast Cancer
De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade
DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4…
- Conditions
- HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer
- Trial name
- Decrescendo (NCT04675827)
- Testing
- Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
- Where
- 85 sites in Australia, Belgium and 4 more
- Volunteers
- 139 people
- Sponsor
- Jules Bordet Institute
Breast Cancer
Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer
This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer.
- Trial name
- NCT07305246
- Testing
- SHR-A1811, Letrozole, TAC/AC-T
- Volunteers
- 120 people
- Sponsor
- First Hospital of China Medical University
Breast Cancer
Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00769470
- Testing
- trastuzumab, carboplatin, docetaxel
- Where
- 15 sites in United States
- Volunteers
- 18 people
- Sponsor
- Translational Oncology Research International
Breast Cancer, HER2-positive Breast Cancer
Radiation Omission in Patients With HER2 Overexpressing Tumors With Pathologic Complete Response
The purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel…
- Trial name
- NCT05371860
- Testing
- Omit breast radiation
- Where
- United States
- Sponsor
- Armando Giuliano
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast, Breast Diseases
- Trial name
- MAGNETIC1 (NCT05814224)
- Testing
- Liquid biopsy and CT scan
- Where
- 7 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
HER2-positive Breast Cancer
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel.
- Trial name
- NCT04034823
- Testing
- KN035, Trastuzumab, Docetaxel
- Volunteers
- 59 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without…
- Trial name
- NCT01480674
- Testing
- Trastuzumab
- Where
- 78 sites in France
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
HR-positive, HER2-negative Advanced Breast Cancer
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced…
- Trial name
- NCT04796623
- Testing
- TQB3616 capsules, Fulvestrant injection
- Where
- 17 sites in China
- Volunteers
- 122 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by…
- Conditions
- Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer
- Trial name
- NCT00194779
- Testing
- doxorubicin hydrochloride, cyclophosphamide, paclitaxel
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Washington
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