Clinical trials: HR+ HER2 Breast Cancer
HR-positive, HER2-negative Breast Neoplasms
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant…
- Trial name
- NCT05365178
- Testing
- TQB3616 capsule, Fulvestrant injection
- Where
- 88 sites in China
- Volunteers
- 432 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HER2+/HR+ Breast Cancer
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant
This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant.
- Trial name
- NCT04224272
- Testing
- ZW25 (Zanidatamab), Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 51 people
- Sponsor
- Jazz Pharmaceuticals
Breast Cancer
Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer
Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly…
- Trial name
- NCT05063136
- Testing
- Capecitabine+endocrine therapy
- Where
- China
- Volunteers
- 1,979 people
- Sponsor
- Henan Cancer Hospital
Advanced Breast Cancer, Metastatic Breast Cancer
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma
- Trial name
- NCT05191004
- Testing
- NUV-422, Fulvestrant
- Where
- 5 sites in United States
- Sponsor
- Nuvation Bio Inc.
Solid Tumor, Microsatellite Instability-High (MSI-H) Solid Tumors
A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors
The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.
- Conditions
- Solid Tumor, Microsatellite Instability-High (MSI-H) Solid Tumors, Cutaneous Melanoma, Pancreatic Cancer
- Trial name
- PACT (NCT02791334)
- Testing
- LY3300054, Ramucirumab, Abemaciclib
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 164 people
- Sponsor
- Eli Lilly and Company
Breast Cancer Female, HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor…
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer
- Trial name
- NCT04088110
- Testing
- Pyrotinib, Trastuzumab, Aromatase Inhibitors
- Where
- China
- Volunteers
- 77 people
- Sponsor
- Fuzhou General Hospital
Advanced Breast Cancer, Female Breast Cancer
This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c in Combination With Fluvestrant ± Goseraline Versus Placebo Combined With Fulvestrant ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer.
This is a multicenter, randomized, double-blind, placebo-controlled Phase iii clinical study evaluating the efficacy and safety of FCN- 437c in combination with fluvestrant ± goseraline versus placebo in combination with…
- Trial name
- NCT05438810
- Testing
- FCN-437c,Fulvestrant,Goserelin acetate
- Where
- China
- Volunteers
- 312 people
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC
The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally…
- Trial name
- PRECIOUS (NCT04937660)
- Where
- 12 sites in Egypt, Jordan and 3 more
- Volunteers
- 185 people
- Sponsor
- Pfizer
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative…
- Trial name
- CAPItello-292 (NCT04862663)
- Testing
- Capivasertib, Fulvestrant, Palbociclib
- Where
- 225 sites in United States, Argentina and 21 more
- Volunteers
- 893 people
- Sponsor
- AstraZeneca
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Advanced HR+ HER2 Negative Breast Carcinoma
H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study
This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ advanced breast cancer; exploring potential…
- Trial name
- NCT05167643
- Testing
- Enituzumab injection+Abesili tablets+Anastrozole tablets
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Metastatic Breast Cancer
Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer
HR+/HER2+（Human epidermal growth factor receptor 2 positive and hormone receptor positive）metastatic breast cancer is a special subtype of HER2+breast cancer.
- Trial name
- NCT04034589
- Testing
- Pyrotinib combined with fulvestrant
- Where
- 2 sites in China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib.
- Trial name
- NCT05966584
- Testing
- Benralizumab, fulvestrant or AIs) and PI3K inhibition (alpelisib)
- Where
- 7 sites in United States
- Volunteers
- 1 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
PIK3CA Mutations, Advanced Solid Tumors, Adult
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of…
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer
- Trial name
- NCT07383506
- Testing
- CGT6297
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Cogent Biosciences, Inc.
HR+ / HER2- Advanced Breast Cancer
A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.
Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer
- Trial name
- NCT07557004
- Testing
- SH3765+Fulvestrant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
Breast Cancer
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer
Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The…
- Trial name
- NCT06000033
- Testing
- Disitamab Vedotin+Anlotinib
- Volunteers
- 35 people
- Sponsor
- Qilu Hospital of Shandong University
Breast Cancer
Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer
To investigate the efficacy and safety of Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR+/HER2+ Metastatic Breast Cancer
- Trial name
- NCT05574881
- Testing
- Dalpiciclib, Fulvestrant, Pertuzumab
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Fudan University
Breast Cancer
Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -
This is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial.
- Trial name
- DxCARTES (NCT03819010)
- Testing
- Pre treatment Recurrence Score:18-25 Letrozole + Palbociclib, Pre treatment Recurrence Score:26-100 Letrozole + Palbociclib
- Where
- 18 sites in Portugal, Spain
- Volunteers
- 66 people
- Sponsor
- MedSIR
Locally Advanced Breast Cancer, Hormone Receptor Positive，HER2-negative Breast Cancer
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy
Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection
- Trial name
- NCT05809024
- Testing
- letrozole
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Yongsheng Wang