Clinical trials: Locally Advanced Breast Carcinoma, 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 Cancer, Solid Tumor
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in…
- Trial name
- NCT06609187
- Testing
- GNC-077
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Locally Advanced or Metastatic Solid Tumors, PTEN Loss or Low Expression
A Single-arm, Open-label, Multicenter, Phase Ib/II Clinical Trial of CVL237 Tablets in Combination With Serplulimab Injection for the Treatment of Advanced Solid Tumors With PTEN Loss or Low Expression
This is a single-arm, open-label, multicenter, Phase Ib/II clinical trial of CVL237 tablets in combination with serplulimab injection for the treatment of advanced solid tumors with PTEN loss or low expression
- Trial name
- NCT07446049
- Testing
- CVL237 tablets
- Volunteers
- 180 people
- Sponsor
- Convalife (Shanghai) Co., Ltd.
Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available, If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT
FDG PET-CT in Advanced Breast Cancer
This study is a prospective cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer receiving first-line systemic…
- Trial name
- PET-000 (NCT07173868)
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
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
Early and Locally Advanced Breast Cancer
ABCSG 61 / TEODOR : Neoadjuvant TrEatment Optimization Driven by Circulating Tumor DNA and endOcrine Responsiveness
The goal of this performance study is to learn if treatment with neoadjuvant endocrine therapy compared to chemotherapy has comparable efficacy, but better quality of life outcomes in endocrine responsive participants with early…
- Trial name
- TEODOR (NCT07084558)
- Testing
- blood sample for Signatera (TM) test, biopsy for Ki-67 assessment, FFPE tumor sample for Signatera (TM) test (archived)
- Where
- 14 sites in Austria
- Volunteers
- 350 people
- Sponsor
- Austrian Breast & Colorectal Cancer Study Group
Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
- Trial name
- Morpheus-panBC (NCT03424005)
- Testing
- Capecitabine, Atezolizumab, Ipatasertib
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 1,132 people
- Sponsor
- Hoffmann-La Roche
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.
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.
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, 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 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.
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Trial name
- NCT04771520
- Testing
- Avapritinib
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- M.D. Anderson Cancer Center
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
Breast Cancer
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles.
- Trial name
- NCT07416253
- Testing
- Trastuzumab rezetecan, Trastuzumab deruxtecan
- Volunteers
- 68 people
- Sponsor
- Henan Cancer Hospital
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