Clinical trials: HER2-positive Breast Cancer
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
HER-2 Positive Breast Cancer
Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast Cancer
The purpose of the investigators study is to compare the efficacy and safety of combining trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy in Chinese HER2-positive breast cancer…
- Trial name
- NCT01428414
- Testing
- Trastuzumab, Paclitaxel, Epirubicin
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Zhimin Shao
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
This stage IV trial examines how a mutation in HSD3B1 (1245C) gene affects treatment of stage I-III breast cancer. This trial may help researchers determine if mutations in HSD3B1 decreases the efficacy of aromatase inhibitor…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Adenocarcinoma
- Trial name
- NCT05183828
- Testing
- Biospecimen Collection, Letrozole, Questionnaire Administration
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Washington
Breast Cancer, Metastatic Cancer
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05205200
- Testing
- SHR-1316, SHR6390, Nab paclitaxel
- Where
- China
- Volunteers
- 338 people
- Sponsor
- Fudan University
Breast Cancer
Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab
Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity.
- Trial name
- NCT00130507
- Testing
- Vinorelbine, Capecitabine, Trastuzumab
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation…
- Trial name
- DESCENT (NCT07153757)
- Testing
- Endocrine Therapy of Physician's Choice
- Where
- China
- Volunteers
- 2,934 people
- Sponsor
- Fudan University
HER2-positive Breast Cancer
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib.
- Trial name
- NCT04220203
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer
Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).
- Trial name
- NCT03424473
- Testing
- Tucatinib
- Sponsor
- Seagen Inc.
Human Epithelial Receptor (HER)-2 Positive Breast Cancer
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy.
- Trial name
- NCT01764022
- Testing
- Trastuzumab, Paclitaxel
- Where
- 36 sites in Belarus, India and 2 more
- Volunteers
- 225 people
- Sponsor
- Biocad
Breast Cancer, Breast Cancer Female
HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer.
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Cancer, Male, Invasive Breast Cancer
- Trial name
- NCT03387553
- Testing
- Dendritic Cell Vaccine (DC1), Neoadjuvant Chemotherapy, Curative Surgery
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage…
- Trial name
- NCT04629846
- Testing
- Trastuzumab, QL1209, Pertuzumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
HER2 Positive Breast Cancer
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer.
- Trial name
- HER2CLIMB-05 (NCT05132582)
- Testing
- Tucatinib, Trastuzumab, Pertuzumab
- Where
- 307 sites in United States, Australia and 21 more
- Volunteers
- 654 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Advanced Breast Cancer, Advanced Breast Carcinoma
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50).
- Conditions
- Advanced Breast Cancer, Advanced Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma
- Trial name
- PONTIAC (NCT06486883)
- Testing
- Trastuzumab deruxtecan (T-DXd, DS-8201a), CDK4/6i plus ET
- Where
- 79 sites in Austria, Belgium and 8 more
- Volunteers
- 200 people
- Sponsor
- MedSIR
Breast Cancer
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
- Trial name
- NCT05549505
- Testing
- ARV-471, Anastrozole, Surgical resection of breast tumor
- Where
- 49 sites in United States, Georgia and 2 more
- Volunteers
- 152 people
- Sponsor
- Arvinas Inc.
Breast Cancer
A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole.
- Trial name
- VICTORIANE (NCT02730091)
- Testing
- Letrozole, Anastrozole, Vinorelbine
- Where
- France
- Volunteers
- 98 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Breast Neoplasms
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.
- Trial name
- NCT04568902
- Testing
- H3B-6545, Antihistamine
- Where
- 2 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Eisai Co., Ltd.
Metastatic Breast Cancer, Recurrent Breast Cancer
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy.
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer, Advanced Malignancies
- Trial name
- NCT06202261
- Testing
- TQB2930 for injection, Paclitaxel for injection (albumin-bound), TQB3616 capsule
- Where
- 2 sites in China
- Volunteers
- 154 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Adenocarcinoma, HER2 Positive Breast Carcinoma
Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is…
- Conditions
- Breast Adenocarcinoma, HER2 Positive Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- Trial name
- NCT00005970
- Testing
- Aromatase Inhibition Therapy, Cyclophosphamide, Doxorubicin Hydrochloride
- Where
- 157 sites in United States, Canada and 2 more
- Volunteers
- 3,436 people
- Sponsor
- National Cancer Institute (NCI)
HR+/HER2- Early Breast Cancer
A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer
The purpose of this clinical trial is to evaluate the efficacy and safety of Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide for HRD-positive, HR+/HER2- early breast cancer.
- Trial name
- NCT07162051
- Testing
- Fuzaparib, standard chemotherapy
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Xijing Hospital
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