Clinical trials: HER2 Low Breast Cancer
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8
Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- LoTam (NCT06671912)
- Testing
- Anastrozole, Letrozole, Exemestane
- Where
- 732 sites in United States, Puerto Rico
- Volunteers
- 1,556 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer
To find a recommended dose of valemetostat that can be given in combination with trastuzumab deruxtecan to patients with low/ultra-low HER2-expressing metastatic breast cancer.
- Trial name
- NCT05633979
- Testing
- Trastuzumab deruxtecan, Valemetostat
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- M.D. Anderson Cancer Center
Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer.
- Trial name
- NCT07497386
- Testing
- Trastuzumab Rezetecan for Injection, Trastuzumab Deruxtecan for Injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
Breast Neoplasms, Triple Negative Breast Neoplasms
Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer
Breast cancer is the most common cancer in women worldwide. Its molecular classification, based on hormone receptors (estrogen and progesterone), HER2 and Ki-67, defines subtypes with different prognoses and treatments.
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HER2-Positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- Trial name
- NCT07856225
- Testing
- CDK4/6 Inhibitors, Anti-HER2 Therapy, Standard Breast Cancer Treatment
- Where
- Colombia
- Volunteers
- 370 people
- Sponsor
- Fundación Santa Fe de Bogota
Breast Cancer, Metastatic Breast Cancer
T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases
TUXEDO-4 is an international, multicentric, single arm, phase II study aiming to gather additional solid evidence of Trastuzumab-Deruxtecan (T-DXd) activity in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-low…
- Trial name
- TUXEDO-4 (NCT06048718)
- Testing
- Trastuzumab-Deruxtecan (T-DXd)
- Where
- 13 sites in Austria, Spain
- Volunteers
- 28 people
- Sponsor
- MedSIR
Breast Cancer With Brain Metastasis, HER2-low Expressing Breast Cancer
T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis
A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Bevicizumab in HER2-low breast cancer with brain metastasis.
- Trial name
- THUMB (NCT07150208)
- Testing
- Bevacizumab (Bev), Trastuzumab Deruxtecan (T-DXd)
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fudan University
Metastatic Breast Cancer
Low -Dose-bevacizumab and Pemetrexed Versus TPC in Metastatic HER2-negative Breast Cancer Patients
This is a single-center, open, randomized, controlled phase 2 clinical trial designed to compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast cancer patients after failure of taxanes and…
- Trial name
- NCT02829008
- Testing
- low-dose-bevacizumab/pemetrexed, Treatment of physician's choice
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Cancer
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
- Trial name
- NCT06227117
- Testing
- Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin
- Where
- 5 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Breast Cancer
Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil
A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE<10%) metastatic HER2-Low breast cancer.
- Trial name
- NCT06231693
- Testing
- Trastuzumab deruxtecan
- Where
- 2 sites in Brazil
- Volunteers
- 2 people
- Sponsor
- AstraZeneca
Lobular Breast Carcinoma
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
The NAPOLI Study is a retrospective multicenter observational study designed to characterize hormone receptor-negative/low invasive lobular carcinoma of the breast.
- Trial name
- NAPOLI (NCT07613151)
- Testing
- Upfront Breast Surgery, Adjuvant Radiotherapy, Endocrine Therapy
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Istituto Oncologico Veneto IRCCS
Breast Cancer
Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer
A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia
- Trial name
- EXPLORE (NCT06727227)
- Testing
- trastuzumab deruxtecan
- Where
- 14 sites in Bulgaria, Slovenia
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis.
- Trial name
- NCT07203729
- Testing
- Trastuzumab Rezetecan, Chemotherapy of Physician's Choice
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Cancer, Gastric Cancer
IKS014 in Advanced Solid Tumors That Express HER2
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate…
- Conditions
- Breast Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- Trial name
- NCT05872295
- Testing
- IKS014
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 165 people
- Sponsor
- Iksuda Therapeutics Ltd.
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
HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC
To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-low advanced breast cancer patients treated with ADC
- Trial name
- NCT05834699
- Testing
- HER2 expression of circulating tumor cells
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Beijing 302 Hospital
Advanced Breast Cancer
A Study of RC48-ADC in Subjects With Advanced Breast Cancer
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression
- Trial name
- NCT03052634
- Testing
- RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive), RC48-ADC 2.5 mg/kg (HER2 Positive)
- Where
- 7 sites in China
- Volunteers
- 112 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Breast Cancer
Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative…
- Trial name
- NCT06656624
- Testing
- Ribociclib combined with AI±OFS, physician's choice of chemotherapy sequential Ribociclib combined with AI±OFS
- Where
- China
- Volunteers
- 190 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4…
- Conditions
- Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms
- Trial name
- NCT04561362
- Testing
- BT8009, Pembrolizumab
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 329 people
- Sponsor
- BicycleTx Limited