Clinical trials: Metastatic HER2+ Advanced Breast Cancer, open to volunteers
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and…
- Trial name
- ELENI (NCT07563595)
- Testing
- Elacestrant, Standard of care (Investigator Choice)
- Where
- 3 sites in Germany
- Volunteers
- 500 people
- Sponsor
- iOMEDICO AG
Breast Cancer
Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in…
- Trial name
- REPARP (NCT05378204)
- Testing
- Main study:, Sub-study:
- Where
- 25 sites in France
- Volunteers
- 120 people
- Sponsor
- Institut Claudius Regaud
Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer
It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.
- Trial name
- NCT05430399
- Testing
- utidelone, docetaxel
- Where
- 2 sites in China
- Volunteers
- 349 people
- Sponsor
- Sun Yat-sen University
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic).
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT04090567
- Testing
- Cediranib, Ceralasertib, Olaparib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 13 sites in United States
- Volunteers
- 260 people
- Sponsor
- Pfizer
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT06179303
- Testing
- Abemaciclib, Anastrozole, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.
- Trial name
- NCT06929325
- Testing
- Sirolimus for Injection (Albumin-bound), Fulvestrant Injection
- Where
- China
- Volunteers
- 312 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Advanced Metastatic Breast Cancer
Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
- Trial name
- LEGO (NCT06706557)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- European Institute of Oncology
Solid Tumors (Phase 1), HNSCC
MTX-531-001 Phase 1 Study in Advanced Solid Tumors
This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors.
- Conditions
- Solid Tumors (Phase 1), HNSCC, Endometrial Cancer, Her2-negative Metastatic Breast Cancer
- Trial name
- NCT07874880
- Testing
- MTX-531
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- MEKanistic Therapeutics, Inc.
Breast Cancer Stage IV
HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan
This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2…
- Trial name
- ACROSS-TROP2 (NCT06236269)
- Testing
- Sacituzumab Govitecan
- Where
- 10 sites in Spain
- Volunteers
- 50 people
- Sponsor
- SOLTI Breast Cancer Research Group
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
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
Breast Cancer
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer…
- Trial name
- NCT07648914
- Testing
- BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel
- Where
- China
- Volunteers
- 446 people
- Sponsor
- Sichuan Baili Pharmaceutical 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 Metastatic Breast Cancer, First-line Treatment
Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial
The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of…
- Trial name
- NCT06278870
- Testing
- disitamab vedotin, Pyrotinib, trastuzumab
- Where
- China
- Volunteers
- 312 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Epithelial Tumors, Malignant
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
- Trial name
- MYE Symphony (NCT05969041)
- Testing
- MT-302 (A)
- Where
- 6 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Myeloid Therapeutics
HER2-negative Breast Cancer, Metastatic Breast Cancer
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced…
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Metaplastic Breast Carcinoma, TNBC - Triple-Negative Breast Cancer
- Trial name
- NCT05660083
- Testing
- L-NMMA
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- The Methodist Hospital Research Institute