Clinical trials: HER2-positive Breast Cancer
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
Estrogen Receptor Negative, HER2 Positive Breast Carcinoma
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual…
- Conditions
- Estrogen Receptor Negative, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Invasive Breast Carcinoma
- Trial name
- NCT02945579
- Testing
- Undergo EBRT, Laboratory Biomarker Analysis, Quality-of-Life Assessment
- Where
- 8 sites in United States
- Volunteers
- 120 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, HER2-positive Breast Cancer
Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive BC
At present, the incidence rate of breast cancer has exceeded that of lung cancer, becoming the largest cancer in the world. HER2 overexpression breast cancer accounts for about 20%~30% of all breast cancer patients.
- Trial name
- NCT05918328
- Testing
- Albumin paclitaxel+trastuzumab+pyrrolitinib, Docetaxel+Carboplatin+trastuzumab+Parstuzumab
- Where
- China
- Volunteers
- 610 people
- Sponsor
- Henan Cancer Hospital
HER2-positive Breast Cancer
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not…
- Trial name
- HERO (NCT05705401)
- Testing
- Standard of Care Adjuvant Breast Radiation, Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
- Where
- 418 sites in United States, Puerto Rico
- Volunteers
- 1,300 people
- Sponsor
- NRG Oncology
Breast Cancer
Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer
The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive.
- Trial name
- NCT01325207
- Testing
- Trastuzumab
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Northwestern University
Breast Cancer
S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer
This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus…
- Trial name
- NCT02137837
- Testing
- Fulvestrant, Anastrozole, Everolimus
- Where
- 223 sites in United States
- Volunteers
- 37 people
- Sponsor
- SWOG Cancer Research Network
Metastatic Breast Cancer, Carcinomatous Meningitis
Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis
The purpose of this study is: Phase I: To determine the Trastuzumab maximum tolerated dose (MTD) when weekly administrated by intrathecal or intraventricular route to reach a intra CSF target concentration (30 µg/mL) near the…
- Trial name
- HIT (NCT01373710)
- Testing
- Trastuzumab
- Where
- 10 sites in France
- Volunteers
- 34 people
- Sponsor
- Institut Curie
Breast Neoplasms
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks…
- Trial name
- TP-II (NCT03272477)
- Testing
- Perjeta Injectable Product, Herceptin, Tamoxifen
- Where
- Germany
- Volunteers
- 257 people
- Sponsor
- Palleos Healthcare GmbH
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
Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Description of the choices for second line treatment, in the normal clinical practice of the centers adhering to the Hermione Network, in patients affected by advanced HR+/HER2- breast cancer who progressed after CDK4/6i in…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
- Trial name
- HERMIONE-13 (NCT05173103)
- Where
- 29 sites in Italy
- Volunteers
- 254 people
- Sponsor
- University of Milano Bicocca
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Breast Cancer, HER2-positive Breast Cancer
BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer
Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care
- Trial name
- BRE-10 (NCT06441890)
- Testing
- Paclitaxel, Nab-paclitaxel, Docetaxel
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Illinois Chicago
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer
This randomized phase II trial studies how well olaparib with or without atezolizumab work in treating patients with non-HER2-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), that cannot…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable Breast Carcinoma, Metastatic Breast Carcinoma
- Trial name
- NCT02849496
- Testing
- Atezolizumab, Biopsy Procedure, Biospecimen Collection
- Where
- 58 sites in United States
- Volunteers
- 89 people
- Sponsor
- National Cancer Institute (NCI)
HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence.
- Trial name
- NCT04622319
- Testing
- DS-8201a, T-DM1
- Where
- 482 sites in United States, Argentina and 29 more
- Volunteers
- 1,600 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
HR-positive, HER2-negative Breast Neoplasms
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant…
- Trial name
- NCT05365178
- Testing
- TQB3616 capsule, Fulvestrant injection
- Where
- 88 sites in China
- Volunteers
- 432 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve…
- Trial name
- PEONY (NCT02586025)
- Testing
- FEC Chemotherapy, Surgery, Docetaxel
- Where
- 23 sites in China, South Korea and 2 more
- Volunteers
- 329 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Hormone-receptor Positive Breast Cancer
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for…
- Trial name
- NCT04872985
- Testing
- Pyrotinib, Epirubicin, Doxorubicin Hydrochloride Liposome Injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Metastatic Breast Cancer
Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer
To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced…
- Trial name
- BOOSTER (NCT01989780)
- Testing
- Paclitaxel, Bevacizumab, Letrozole
- Where
- Japan
- Volunteers
- 160 people
- Sponsor
- Japan Breast Cancer Research Group
Breast Cancer
Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer
The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
- Trial name
- Lilac (NCT01901146)
- Testing
- ABP 980, Trastuzumab, Paclitaxel
- Where
- 98 sites in Belarus, Brazil and 16 more
- Volunteers
- 725 people
- Sponsor
- Amgen
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