Clinical trials: HER2 Negative Breast Cancer
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 Neoplasms
Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
RATIONALE: Patients with HER2-negative breast cancer not responding to initial neoadjuvant chemotherapy might have lower chances for a pathologic complete response (pCR) at definitive surgery, indicating worse prognosis.
- Trial name
- NCT06121570
- Testing
- Sentinel Lymph Node Biopsy (SLNB), Doxorubicin, Epirubicin
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer, ER-Negative Breast Cancer
De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade
DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4…
- Conditions
- HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer
- Trial name
- Decrescendo (NCT04675827)
- Testing
- Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
- Where
- 85 sites in Australia, Belgium and 4 more
- Volunteers
- 139 people
- Sponsor
- Jules Bordet Institute
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast, Breast Diseases
- Trial name
- MAGNETIC1 (NCT05814224)
- Testing
- Liquid biopsy and CT scan
- Where
- 7 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
HER2-negative Breast Cancer, Metastatic Breast Cancer
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.
The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1).
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- RADIOLA (NCT05340413)
- Testing
- Olaparib
- Where
- 5 sites in Spain
- Volunteers
- 65 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Cancer
Neoadjuvant Paclitaxel Versus BIBF 1120 Priming Followed by BIBF 1120 Plus Paclitaxel in Early HER-2 Negative Breast Cancer With Proteomic and Dynamic Imaging Correlates
The investigators plan to study the efficacy of the combination of weekly paclitaxel + BIBF 1120 in early breast cancer using a neoadjuvant schedule and a randomized phase-II trial design, comparing the efficacy vs.
- Trial name
- NCT01484080
- Testing
- BIBF + Paclitaxel, Paclitaxel
- Where
- 3 sites in Spain
- Volunteers
- 140 people
- Sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 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.
Stage II Breast Cancer, Stage III Breast Cancer
Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
Molecular expression in breast cancer (BC) defines special fenotypes with different prognostic and predictive features.Since the addition of trastuzumab and lapatinib to chemotherapy, HER2 overexpressing tumors have become the…
- Trial name
- NCT01431196
- Testing
- Autologous dendritic cell vaccination
- Where
- Spain
- Volunteers
- 29 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
HR-positive, HER2-negative Advanced Breast Cancer
A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer
This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced…
- Trial name
- NCT04796623
- Testing
- TQB3616 capsules, Fulvestrant injection
- Where
- 17 sites in China
- Volunteers
- 122 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by…
- Conditions
- Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer, Progesterone Receptor-negative Breast Cancer
- Trial name
- NCT00194779
- Testing
- doxorubicin hydrochloride, cyclophosphamide, paclitaxel
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Washington
Breast Cancer
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a…
- Trial name
- NCT02593227
- Testing
- Low dose FRα vaccine, Cyclophosphamide, High dose FRα vaccine
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Marker Therapeutics, Inc.
Breast Cancer
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- VIKTORIA-1 (NCT05501886)
- Testing
- Gedatolisib, Palbociclib, Fulvestrant
- Where
- 235 sites in United States, Argentina and 21 more
- Volunteers
- 701 people
- Sponsor
- Celcuity Inc
Metastatic Breast Cancer
Observation of Medical Treatments in MBC HER2-negative Patients
While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors.
- Trial name
- AMBRA (NCT02365831)
- Testing
- Observation of treatment management
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Consorzio Oncotech
Metastatic Breast Cancer
Phase II Study of Carboplatin and Bevacizumab (Avastin) for ER Neg, PR Neg, and HER2/Neu Neg Metastatic Breast Cancer
The purpose of this study is to determine the progression free survival (PFS) of metastatic ER, PR and HER2/neu negative breast cancers to the combination of carboplatin and bevacizumab (Avastin®) therapy.
- Trial name
- NCT00517361
- Testing
- carboplatin, bevacizumab
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Chicago
Metastatic Breast Cancer
Phase II Trial of Doxil, Carboplatin, Bevacizumab in Triple Negative Untreated Metastatic Breast Cancer
The purpose of this research study is to look at the effectiveness of a combination of doxil, carboplatin and bevacizumab on metastatic breast cancer.
- Trial name
- NCT00608972
- Testing
- Doxil, Carboplatin, Bevacizumab
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- Rutgers, The State University of New Jersey
Breast Adenocarcinoma, HER2/Neu Negative
Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer
This randomized phase III trial studies how well eribulin mesylate or paclitaxel work as first- or second-line therapy in treating patients with stage IIIC-IV breast cancer that has come back.
- Conditions
- Breast Adenocarcinoma, HER2/Neu Negative, Invasive Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7
- Trial name
- NCT02037529
- Testing
- Eribulin Mesylate, Laboratory Biomarker Analysis, Paclitaxel
- Where
- 39 sites in United States
- Volunteers
- 201 people
- Sponsor
- Academic and Community Cancer Research United
Tubular Breast Cancer, Mucinous Breast Cancer
Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .
- Conditions
- Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of Breast
- Trial name
- NCT03201861
- Testing
- Paclitaxel, Cisplatin, EC to docetaxel or paclitaxel
- Where
- China
- Volunteers
- 762 people
- Sponsor
- RenJi Hospital
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
Premenopausal Breast Cancer
Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer
This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor…
- Trial name
- PEER (NCT02990845)
- Testing
- Pembrolizumab/ Exemestane/ Leuprolide
- Where
- Taiwan
- Volunteers
- 16 people
- Sponsor
- National Taiwan University Hospital
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