Clinical trials: HER2 Positive Breast Cancer
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
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line…
- Trial name
- CLEOPATRA (NCT00567190)
- Testing
- Pertuzumab, Trastuzumab, Docetaxel
- Where
- 322 sites in United States, Argentina and 24 more
- Volunteers
- 808 people
- Sponsor
- Genentech, Inc.
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
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
Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma
Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of alpha-TEA when given together with trastuzumab and to see how well they work for the treatment of HER2+ breast cancer that does not respond to treatment (refractory)…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Metastatic Breast Carcinoma, Refractory Breast Carcinoma
- Trial name
- NCT04120246
- Testing
- Alpha-tocopheryloxyacetic Acid, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Veana Therapeutics
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
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
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
- Trial name
- ExteNET (NCT00878709)
- Testing
- neratinib
- Where
- 494 sites in United States, Australia and 38 more
- Volunteers
- 2,840 people
- Sponsor
- Puma Biotechnology, Inc.
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.
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
This single-arm, multicenter, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with whole brain radiotherapy on brain metastases in patients with HER-2 positive breast cancer.
- Trial name
- NCT01363986
- Testing
- trastuzumab [Herceptin]
- Where
- 16 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Recurrent / Metastatic Breast Cancer
Effect of Montmorillonite Power or Loperamide on the Pharmacokinetics of Pyrotinib in Healthy Subjects
The study will assess the effect of anti-diarrhea drug Montmorillonite Power or Loperamide on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects.
- Trial name
- NCT05252546
- Testing
- pyrotinib tablet, Montmorillonite Power, Loperamide
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
HER2 + Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously…
- Trial name
- NCT07824869
- Testing
- HLX22, Trastuzumab, Capecitabine
- Volunteers
- 90 people
- Sponsor
- Shanghai Henlius Biotech
HER2 Positive Solid Tumors
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies
- Trial name
- NCT04460456
- Testing
- SBT6050, pembrolizumab, Cemiplimab
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 58 people
- Sponsor
- Silverback Therapeutics
Breast Cancer
A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Trial name
- NCT07358377
- Testing
- HRS-6209 Capsules and fulvestrant injection
- Where
- 6 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Atridia Pty Ltd.
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early…
- Trial name
- NCT00964704
- Testing
- bevacizumab [Avastin], capecitabine [Xeloda], docetaxel
- Sponsor
- Hoffmann-La Roche
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
HER2 Positive Metastatic Breast Cancers
A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine…
- Trial name
- NCT02025192
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Seagen Inc.