Clinical trials: HER2+ Breast Cancer
HER2-low Breast Cancer
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
- Trial name
- NCT06957886
- Testing
- BL-M07D1, Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel
- Where
- 2 sites in China
- Volunteers
- 566 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer
To investigate the efficacy and safety of Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR+/HER2+ Metastatic Breast Cancer
- Trial name
- NCT05574881
- Testing
- Dalpiciclib, Fulvestrant, Pertuzumab
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Fudan University
Triple Negative Breast Cancer, Endometrial Cancer
ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
Background: The new drug ONC201 have been shown to kill breast cancer and endometrial cancer cells in the laboratory. The exact mechanism of action is not completely clear yet, but the ONC201 destroys the mitochondria inside the…
- Conditions
- Triple Negative Breast Cancer, Endometrial Cancer, Hormone Receptor Positive, HER2 Negative Breast Cancer
- Trial name
- NCT03394027
- Testing
- ONC201
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer
This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2
- Trial name
- NCT00615602
- Testing
- Docetaxel, Trastuzumab, Epirubicin
- Where
- 10 sites in Greece
- Volunteers
- 489 people
- Sponsor
- Hellenic Oncology Research Group
Breast Cancer
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds.
- Trial name
- NCT00191451
- Testing
- Gemcitabine, Carboplatin, Herceptin
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer.
- Trial name
- OVELIA (NCT04906395)
- Testing
- TOL2506, Tamoxifen, Letrozole Tablets
- Where
- 59 sites in United States, Argentina and 5 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Breast Cancer
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- VIKTORIA-1 (NCT05501886)
- Testing
- Gedatolisib, Palbociclib, Fulvestrant
- Where
- 235 sites in United States, Argentina and 21 more
- Volunteers
- 701 people
- Sponsor
- Celcuity Inc
Breast Cancer
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor…
- Trial name
- NCT05950945
- Testing
- Trastuzumab Deruxtecan
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 250 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver…
- Trial name
- NCT00014430
- Testing
- trastuzumab, vinorelbine ditartrate
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
HER2-positive Breast Cancer, Adjuvant Therapy
Efficacy and Safety of Adjuvant Docetaxel and Trastuzumab in Stage I HER2-positive Breast Cancer
Among women with stage I HER2-positive breast cancer, adjuvant weekly paclitaxel plus trastuzumab (PH, qw×12) is one of the standard therapies.
- Trial name
- NCT05189067
- Testing
- Paclitaxel, Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 190 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, HR+/HER2-negative Breast Cancer
A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer
The clinical efficacy of fulvestrant and/or palbociclib in the population of patients with metastatic lesions harboring ESR1 mutations was reported.
- Conditions
- Breast Cancer, HR+/HER2-negative Breast Cancer, Metastasis
- Trial name
- PALPETBIO (NCT03560856)
- Testing
- Fulvestrant + palbociclib
- Volunteers
- 54 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Breast Cancer
Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer
This is an open label, phase III study evaluating the efficacy and safety of Pyrotinib in Combination With Trastuzumab and paclitaxel in patients HER2 Positive and lymph node negative invasive Breast Cancer
- Trial name
- NCT05841381
- Testing
- Pyrotinib, Trastuzumab, Paclitaxel
- Volunteers
- 876 people
- Sponsor
- Fudan University
Metastatic Breast Cancer
Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic Breast Cancer Patients
GIM22-ERICA is a clinical trial investigating the efficacy of two different strategies in HER2 negative MBC treatment. The study will include MBC patients with histologically documented HER2 negative disease, who have progressed…
- Trial name
- NCT05833919
- Testing
- Eribulin Mesylate, Capecitabine
- Where
- 25 sites in Italy
- Volunteers
- 122 people
- Sponsor
- Consorzio Oncotech
Breast Cancer, CDK4/6 Inhibitor
Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4/6 Inhibitors and Hormone Therapy
This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4/6i, to improve patients' quality of life and…
- Trial name
- VIRTUOSA (NCT07190651)
- Testing
- Home questionnaire
- Volunteers
- 50 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Breast Neoplasms, Breast Cancer
Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer
This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective…
- Trial name
- NCT00284180
- Testing
- Vinflunine, Trastuzumab
- Where
- 10 sites in United States
- Volunteers
- 32 people
- Sponsor
- SCRI Development Innovations, LLC
Breast Cancer
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive…
- Trial name
- APHINITY (NCT01358877)
- Testing
- 5-Fluorouracil, Carboplatin, Cyclophosphamide
- Where
- 546 sites in United States, Argentina and 40 more
- Volunteers
- 4,804 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, HER2-positive Breast Cancer
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT07459673
- Testing
- Personalis NeXT Personal, Natera Signatera, fam-trastuzumab deruxtecan-nxki (T-DXd)
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Memorial Sloan Kettering Cancer 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
A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases
This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain…
- Conditions
- Breast Cancer, Brain Metastases, Radiotherapy
- Trial name
- NCT06088056
- Testing
- Combination use of SRT with T-DXd
- Where
- China
- Volunteers
- 17 people
- Sponsor
- Fudan University
Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer
Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer
This is a prospective Single-arm Study to Investigate the Efficacy and Safety of Neoadjuvant treatment with trastuzumab and pyrotinib plus palbociclib and fulvestrant in HER2-positive, ER-positive breast cancer.
- Trial name
- NeoTPPF (NCT05076695)
- Testing
- Palbociclib, trastuzumab, pyrotinib
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Fudan University
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