Clinical trials: HER2 Negative Breast Cancer
Breast Cancer
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy…
- Trial name
- NCT06086340
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Pfizer
Breast Cancer
Study of SKB103 in HER2-negative Breast Cancer
This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer.
- Trial name
- NCT07774624
- Testing
- SKB103 monotherapy
- Volunteers
- 140 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Neoplasms
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
The primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant.
- Trial name
- NCT04544189
- Testing
- Alpelisib, Fulvestrant
- Where
- 24 sites in China
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Estrogen Receptor Negative, Head and Neck Squamous Cell Carcinoma
Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction
This phase I trial studies the side effects and best dose of talazoparib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or…
- Conditions
- Estrogen Receptor Negative, Head and Neck Squamous Cell Carcinoma, HER2/Neu Negative, Hormone-Resistant Prostate Cancer
- Trial name
- NCT02567396
- Testing
- Laboratory Biomarker Analysis, Pharmacological Study, Talazoparib
- Sponsor
- National Cancer Institute (NCI)
HER2-positive Breast Cancer, Breast Cancer
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer, Breast Cancer Stage, Recurrent Breast Cancer
- Trial name
- T-DM1 (NCT03530696)
- Testing
- Palbociclib, T-DM1
- Where
- 16 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Arizona
Advanced Breast Cancer
Trial to Evaluate Efficacy and Safety of Pembrolizumab and Gemcitabine in HER2-negative ABC
Study Design and Treatment: This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with HER2-negative ABC…
- Trial name
- PANGEA (NCT03025880)
- Testing
- Pembrolizumab, Gemcitabine
- Where
- 9 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Spanish Breast Cancer Research Group
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04481113
- Testing
- Abemaciclib, Niraparib Tosylate Monohydrate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- OHSU Knight Cancer Institute
Breast Cancer
An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
This is a single-arm, open-label, exploratory clinical study
- Trial name
- NCT06613373
- Testing
- Dalpiciclib
- Volunteers
- 30 people
- Sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
Breast Cancer Female
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement.
- Trial name
- CARMEN (NCT07242118)
- Testing
- SABR
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Breast Cancer
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast…
- Trial name
- NCT06954961
- Testing
- D-0502, Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 640 people
- Sponsor
- InventisBio Co., Ltd
Breast Cancer
Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
The purpose of this research study is to : Determine how effective cisplatin or carboplatin is in slowing the time it takes for ER negative (estrogen-receptor-negative), PR negative (progesterone receptor-negative), HER2 negative…
- Trial name
- NCT00483223
- Testing
- Cisplatin, carboplatin
- Where
- 10 sites in United States
- Volunteers
- 86 people
- Sponsor
- Massachusetts General Hospital
Advanced Breast Cancer
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy.
- Trial name
- NCT06941142
- Testing
- Sirolimus (albumin - bound), Palbociclib tablet, Fulvestrant injection
- Volunteers
- 382 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Early Breast Cancer
Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.
The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A…
- Trial name
- EGC102 (NCT06884254)
- Testing
- EG1206A, Perjeta
- Where
- United States
- Sponsor
- EirGenix, Inc.
Female Breast Cancer
Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer
The study is a prospective multi-center randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of adjuvant endocrine therapy for operable ER-beta…
- Trial name
- AETNBC (NCT02089854)
- Testing
- Toremifene; Anastrozole
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Peking Union Medical College Hospital
Metastatic Breast Cancer, Recurrent Breast Cancer
Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer.
- Trial name
- NCT02390427
- Testing
- Taselisib, Trastuzumab emtansine, Pertuzumab
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Nancy Lin, MD
Breast Cancer Female, Hormone Receptor Positive Tumor
Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer
Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis.
- Trial name
- LALEAST (NCT03917082)
- Testing
- Tamoxifen Citrate
- Where
- Canada
- Volunteers
- 290 people
- Sponsor
- British Columbia Cancer Agency
Breast Cancer
Use of Sentinel Lymph Node Biopsy in Patients With Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation
The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery.
- Trial name
- NCT04854005
- Testing
- Breast surgery
- Where
- 10 sites in United States
- Volunteers
- 78 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer Female, Breast Cancer
Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients With rCR and pCR in the Breast After NAST
Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the…
- Trial name
- NCT04101851
- Testing
- omission of SLNB
- Where
- 40 sites in Austria, Germany and 2 more
- Volunteers
- 350 people
- Sponsor
- Toralf Reimer, MD PhD
HER2-negative Breast Cancer
Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases
This is a prospective, open-label, phase II platform trial. The purpose of this study is to test the safety and effectiveness of multi-mode thermal therapy combined with immunotherapy in patients with HER2-negative breast cancer…
- Trial name
- NCT07466927
- Testing
- SHR-A1811, SKB264, Pembrolizumab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fudan University
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