Clinical trials: HER2 Negative Breast Neoplasms
Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT07261631
- Testing
- 68Ga-NNS309, 177Lu-DFC413
- Where
- 9 sites in United States, Canada and 5 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
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
Early-stage Breast Cancer
Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in…
- Trial name
- ROSE (NCT05377684)
- Where
- 22 sites in Italy
- Volunteers
- 450 people
- Sponsor
- Ipsen
Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms
A Study of SGN-STNV in Advanced Solid Tumors
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are.
- Conditions
- Carcinoma, Non-Small Cell Lung, HER2 Negative Breast Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
- Trial name
- NCT04665921
- Testing
- SGN-STNV
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 111 people
- Sponsor
- Seagen Inc.
Breast Neoplasms
Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer
The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone…
- Trial name
- NCT02258464
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Background hormonal therapy
- Where
- 71 sites in United States, Austria and 18 more
- Volunteers
- 99 people
- Sponsor
- Bayer
Healthy Subjects
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.
- Trial name
- NCT05551897
- Testing
- Camizestrant, Itraconazole
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
- Trial name
- NCT06227117
- Testing
- Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin
- Where
- 5 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
HR-positive, HER2-negative Advanced Breast Cancer
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
- Trial name
- NCT06950086
- Testing
- TYK-00540
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- TYK Medicines, Inc
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.
- Trial name
- NCT04355520
- Testing
- TQ-B3525, Fulvestrant injection
- Where
- 4 sites in China
- Volunteers
- 42 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk…
- Trial name
- CheckMate 7FL (NCT04109066)
- Testing
- nivolumab, paclitaxel (PTX), anthracycline
- Where
- 240 sites in United States, Argentina and 30 more
- Volunteers
- 521 people
- Sponsor
- Bristol-Myers Squibb
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.
NSCLC, SCLC
Study of Oral MRT-2359 in Selected Cancer Patients
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer…
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL
- Trial name
- NCT05546268
- Testing
- Oral MRT-2359
- Where
- 17 sites in United States
- Volunteers
- 174 people
- Sponsor
- Monte Rosa Therapeutics, Inc
Metastatic Breast Cancer
Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer
This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).
- Trial name
- ESTROTIMP (NCT05486182)
- Testing
- 18F Fluoroestradiol Radiopharmaceutical with PET/CT
- Where
- 11 sites in France
- Volunteers
- 153 people
- Sponsor
- GE Healthcare
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.
Breast Cancer
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
- Trial name
- CONTESSA (NCT03326674)
- Testing
- Tesetaxel and Capecitabine, Capecitabine
- Where
- 207 sites in United States, Australia and 17 more
- Volunteers
- 685 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Cancer
A Phase 2 Trial of Standard Chemotherapy, With or Without BSI-201, in Patients With Triple Negative Metastatic Breast Cancer
The purpose of this clinical trial was to determine whether combining iniparib (BSI-201) with standard chemotherapy in estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor…
- Trial name
- NCT00540358
- Testing
- gemcitabine/carboplatin, iniparib
- Where
- 18 sites in United States
- Volunteers
- 123 people
- Sponsor
- Sanofi
Metastatic Breast Cancer, ER-positive Breast Cancer
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05508906
- Testing
- Palazestrant, Ribociclib, Alpelisib
- Where
- 16 sites in United States, Australia
- Volunteers
- 190 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Post Menopausal Breast Cancer
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer…
- Trial name
- EVEREXES (NCT03176238)
- Testing
- everolimus, exemestane
- Where
- 55 sites in Australia, India and 11 more
- Volunteers
- 235 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer Metastatic, Advanced Breast Cancer
Safety and Pharmacokinetics of ODM-209
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
- Conditions
- Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer
- Trial name
- STESIDES (NCT03878823)
- Testing
- ODM-209
- Where
- 4 sites in Denmark, Finland and 1 more
- Volunteers
- 38 people
- Sponsor
- Orion Corporation, Orion Pharma
Breast Cancer
A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line…
- Trial name
- NCT00929240
- Testing
- bevacizumab [Avastin], capecitabine [Xeloda]
- Where
- 63 sites in Brazil, China and 9 more
- Volunteers
- 287 people
- Sponsor
- Hoffmann-La Roche