Clinical trials: HER2+ Metastatic Breast Cancer (MBC)
Metastatic Breast Cancer
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)].
- Trial name
- VERU-024 (NCT05065411)
- Testing
- Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
- Where
- 30 sites in United States
- Volunteers
- 5 people
- Sponsor
- Veru Inc.
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Breast Cancer, Metastatic
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive…
- Trial name
- ASPEN-09-03 (NCT07007559)
- Testing
- Evorpacept (ALX148), Trastuzumab, Paclitaxel
- Where
- 60 sites in United States, Canada and 6 more
- Volunteers
- 120 people
- Sponsor
- ALX Oncology Inc.
Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel…
- Trial name
- NCT02051751
- Testing
- BYL719, Paclitaxel
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab. The secondary objectives are safety and pharmacokinetic interaction
- Trial name
- NCT00386685
- Testing
- larotaxel (XRP9881), trastuzumab
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Sanofi
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
HER 2 Negative Breast Cancer
A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates
This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer.
- Trial name
- MBC-EA (NCT07520760)
- Testing
- Eribulin in Combination with Anlotinib
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Sun Yat-sen University
HER2 Positive Metastatic Breast Cancer
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received…
- Trial name
- NCT04398108
- Testing
- Margetuximab Margetuximab-IV
- Where
- 3 sites in China
- Volunteers
- 16 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Metastatic Breast Cancer, Metastatic Solid Cancer
HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment.
- Trial name
- HERMIA (NCT06369831)
- Testing
- 68Ga-NOTA-ABSCINT-HER2 PET/CT
- Where
- 7 sites in Austria, Belgium
- Volunteers
- 60 people
- Sponsor
- Abscint NV/SA
Metastatic Breast Cancer, Advanced Breast Cancer
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and…
- Trial name
- ICARUS BREAST (NCT04965766)
- Testing
- U3-1402
- Where
- 11 sites in France
- Volunteers
- 139 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Metastatic Breast Cancer
Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC
The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally…
- Trial name
- PRECIOUS (NCT04937660)
- Where
- 12 sites in Egypt, Jordan and 3 more
- Volunteers
- 185 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified…
- Trial name
- NCT03238196
- Testing
- Erdafitinib, Palbociclib, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Breast Neoplasms, Malignant Tumor of the Breast
Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer
This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or capecitabine) plus trastuzumab vs chemotherapy…
- Trial name
- NCT02229149
- Testing
- Trastuzumab, Pertuzumab, Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- US Oncology Research
Metastatic Breast Cancer in the Brain
Efficacy of Pyrotinib Plus Capecitabine in HER2-positive MBC With Active Brain Metastases That Have Failed ADCs
To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs
- Trial name
- NCT06475443
- Testing
- pyrotinib plus capecitabine
- Volunteers
- 32 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer, Breast Cancer Metastatic
A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2-expressing Metastatic Breast Cancer.
The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without [adjuvant], in patients with human epidermal growth factor receptor 2 (HER2)…
- Trial name
- NCT06746688
- Testing
- ES2B-C001, ISA 51 VD
- Where
- 3 sites in Austria
- Volunteers
- 40 people
- Sponsor
- ExpreS2ion Biotechnologies
Breast Cancer Metastatic
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination…
- Trial name
- NCT05155566
- Where
- 2 sites in Argentina, United Kingdom
- Volunteers
- 847 people
- Sponsor
- Pfizer
Breast Neoplasms
Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy
Post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.
- Trial name
- DD-CMM (NCT02403869)
- Where
- 29 sites in Spain
- Volunteers
- 149 people
- Sponsor
- Celgene
Locally Advance Breast Cancer (LABC), Metastatic Breast Cancer (MBC)
A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab
This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2+ breast cancer.
- Trial name
- NCT01471847
- Testing
- BEZ235 + Trastuzumab Phase l/Phase ll), Lapatinib + Capecitabine (Phase II)
- Where
- 3 sites in Spain, United Kingdom
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B)…
- Conditions
- Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Breast Cancer
- Trial name
- NCT06784193
- Testing
- OP-3136, Fulvestrant, Palazestrant
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 180 people
- Sponsor
- Olema Pharmaceuticals, Inc.