Clinical trials: HER2-positive Advanced Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated…
- Trial name
- reaINAVO (NCT07347600)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 32 sites in China
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Advanced Breast Cancer
PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin
The multicenter, two-cohort, non-comparative, open-label, phase II clinical trial SABINA aims to analyze the safety and efficacy of MEN1611 in monotherapy and in combination with eribulin, a non-taxane chemotherapy agent, in…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- SABINA (NCT05810870)
- Testing
- MEN1611, Eribulin
- Where
- 13 sites in Spain
- Volunteers
- 14 people
- Sponsor
- MedSIR
Metastatic Breast Cancer
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing…
- Trial name
- MACS2096 (NCT01626222)
- Testing
- Exemestane, Everolimus (RAD001)
- Where
- 84 sites in Germany
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer
Novel Double Target Therapy Combined With Chemotherapy in First-line Treatment of HER2+ Breast Cancer, MA-BC-II-038
The purpose of this study was to evaluate the efficacy and safety of pyrotinib combined with trastuzumab and albumin paclitaxel in first-line treatment of HER2-positive advanced or metastatic breast cancer.
- Trial name
- NCT05429294
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 209 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Breast Cancer, Brain Metastases
Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases
This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive/HER2-negative advanced breast cancer…
- Conditions
- Breast Cancer, Brain Metastases, HR+/HER2- Breast Cancer
- Trial name
- NCT07539753
- Testing
- Dalpiciclib, Endocrine Therapy of Physician's Choice, Brain Radiotherapy
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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.
Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer
Trastuzumab Rezetecan Followed by Pyrotinib, Fulvestrant, and Dalpiciclib in HR-Positive, HER2-Positive Advanced Breast Cancer
The purpose of this clinical trial is to evaluate whether, in patients with hormone receptor-positive (HR-positive) and HER2-positive advanced breast cancer whose disease has progressed after trastuzumab-based therapy, switching…
- Conditions
- Metastatic Breast Cancer (MBC), HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07892274
- Testing
- Fulvestrant, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 226 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant…
- Trial name
- NCT03588091
- Testing
- Pyrotinib, Trastuzumab, Docetaxel
- Where
- 17 sites in China
- Volunteers
- 355 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer.
- Trial name
- NCT07797218
- Testing
- Docetaxel, Pyrotinib, Trastuzumab (Herceptin)
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Breast Cancer
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05080842
- Testing
- AC682
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Accutar Biotechnology Inc
Breast Neoplasms
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
The primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant.
- Trial name
- NCT04544189
- Testing
- Alpelisib, Fulvestrant
- Where
- 24 sites in China
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
HR-positive,HER2-negative Breast Cancer
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer.
- Trial name
- NCT06705127
- Testing
- TORIPALIMAB INJECTION(JS001 ), Stereotactic Body Radiation Therapy (SBRT)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
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+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
A Study of PF-06873600 in People With Cancer
The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.
- Trial name
- NCT03519178
- Testing
- PF-06873600, Endocrine Therapy 1, Endocrine Therapy 2
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 155 people
- Sponsor
- Pfizer
Breast Cancer
The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer
This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) Group B: Trastuzumab + Vinorelbine…
- Trial name
- NCT03414658
- Testing
- Vinorelbine, Trastuzumab, Avelumab
- Where
- 17 sites in United States
- Volunteers
- 100 people
- Sponsor
- Adrienne G. Waks
HER2-positive Breast Cancer
A Trial of Eribulin in Combination With HP Neoadjuvant Therapy in Patients With for HER2-Positive BC
To evaluate the pathology complete response rate (pathology Complete Response, pCR) of eribulin combined with trastuzumab + pertuzumab in neoadjuvant therapy for HER-2 positive early or locally advanced breast cancer.
- Trial name
- NCT05945368
- Testing
- Eribulin mesylate injection、Pertuzumab、Trastuzumab
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer, Locally Advanced Breast Cancer
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic…
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Neoadjuvant Chemotherapy, HER2-positive Breast Cancer
- Trial name
- NCT06220214
- Testing
- CEDM, CEDBT, Omnipaque 350mgI/mL Solution for Injection
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alison Stopeck
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 Cancer, HER2-low-expressing Breast Cancer
Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial
This is a single-arm, prospective, non-randomized, single-center, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib combined with epirubicin and cyclophosphamide followed by docetaxel in HR…
- Conditions
- Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy
- Trial name
- NCT05165225
- Testing
- Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.