Clinical trials: HER2-Negative Breast Carcinoma
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Breast Neoplasms
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2)…
- Trial name
- NCT00246571
- Testing
- SU011248, Chemotherapy
- Where
- 113 sites in United States, Bulgaria and 10 more
- Volunteers
- 217 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Metastatic Triple Negative Breast Cancer
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and…
- Trial name
- NCT03330847
- Testing
- Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
- Where
- 141 sites in United States, Belgium and 13 more
- Volunteers
- 273 people
- Sponsor
- AstraZeneca
HR+/HER2- Advanced and/or Metastatic Breast Cancer
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
- Trial name
- NCT05044988
- Testing
- HS-10342
- Volunteers
- 20 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer
This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative…
- Trial name
- NCT00615940
- Testing
- WX-671
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 132 people
- Sponsor
- Heidelberg Pharma AG
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination.
- Trial name
- NCT02023359
- Testing
- Everolimus and exemestane
- Where
- 3 sites in Denmark
- Volunteers
- 7 people
- Sponsor
- Novartis Healthcare A/S
HR-positive,HER2-negative in Advanced Breast Cancer
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen…
- Trial name
- NCT05375461
- Testing
- TQB3616 capsules, Fluvestrin injection
- Where
- 2 sites in China
- Volunteers
- 293 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HER2-Negative Breast Cancer, Triple Negative Breast Cancer
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
This study is designed as an open-label randomized parallel two-arm multicenter efficacy, pharmacokinetics and safety study of intravenously administered eribulin versus intravenously administered vinorelbine in Chinese…
- Conditions
- HER2-Negative Breast Cancer, Triple Negative Breast Cancer, Breast Cancer, Cancer of Breast
- Trial name
- NCT02225470
- Testing
- E7389 (Eribulin Mesylate), Vinorelbine injection
- Where
- 35 sites in China
- Volunteers
- 530 people
- Sponsor
- Eisai Co., Ltd.
Triple Negative Breast Neoplasms
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
- Trial name
- BEGONIA (NCT03742102)
- Testing
- Durvalumab, Capivasertib, Oleclumab
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 243 people
- Sponsor
- AstraZeneca
Advanced/Metastatic HER2-negative Breast Cancer
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in…
- Trial name
- NCT06975371
- Testing
- No drug
- Where
- United States
- Volunteers
- 1,415 people
- Sponsor
- Daiichi Sankyo
Cancer
Observational Study on the Treatment of Patients With Metastatic Breast Cancer
This is a descriptive, retrospective, observational study to generate Real-World Evidence (RWE). This study will evaluate the treatment patterns and outcomes with metastatic or unresectable hormone receptor-positive breast cancer…
- Trial name
- REALNESS (NCT06676436)
- Where
- 4 sites in Brazil
- Volunteers
- 204 people
- Sponsor
- AstraZeneca
Breast Cancer
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal…
- Trial name
- NCT02561832
- Testing
- Olaparib, Carboplatin, Anthracycline
- Where
- 7 sites in United States, Spain
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with…
- Trial name
- NCT06428396
- Testing
- Belzutifan, Fulvestrant, Everolimus
- Where
- 41 sites in United States, Argentina and 7 more
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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.
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.
Breast Cancer
Study of XL147 (SAR245408) or XL765 (SAR245409) in Combination With Letrozole in Subjects With Breast Cancer
Phase 1 of this study will evaluate the maximum tolerated dose (MTD) of XL147 when given in combination with letrozole (Femara) and of XL765 when given in combination with letrozole.
- Trial name
- NCT01082068
- Testing
- XL147 (SAR245408), XL765 (SAR245409), letrozole (Femara)
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 72 people
- Sponsor
- Sanofi