Clinical trials: Hormone Receptor-positive Breast Cancer
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage,Female Breast Cancer
Phase III Study :SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
- Trial name
- NCT04842617
- Testing
- SHR6390
- Where
- China
- Volunteers
- 5,274 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Hormone Receptor Positive Tumor
Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line
This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, HER 2 Negative Breast Cancer
- Trial name
- RIBBIT (NCT03462251)
- Testing
- Ribociclib and aromatase inhibitor or fulvestrant, Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab
- Where
- 27 sites in Germany
- Volunteers
- 41 people
- Sponsor
- iOMEDICO AG
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who…
- Trial name
- NCT01225172
- Testing
- BMS-754807, letrozole
- Where
- 21 sites in United States
- Volunteers
- 77 people
- Sponsor
- Bristol-Myers Squibb
Early Breast Cancer
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals
Progesterone Receptor Positive Tumor: Max 1 Line of Prior Chemotherapy, no Prior Hormone Therapy
Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers
This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma.
- Trial name
- NCT02052128
- Testing
- onapristone
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Arno Therapeutics
Metastatic Breast Cancer
A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
- Trial name
- NCT07071337
- Testing
- SKB264, Nab-paclitaxel, Paclitaxel
- Where
- 2 sites in China
- Volunteers
- 430 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer (Locally Advanced or Metastatic)
A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to compare the objective response rates (ORR) of different doses of BL0175 in patients with postmenopausal hormone receptor (HR)-positive, human epidermal growth factor receptor 2…
- Trial name
- NCT07658183
- Testing
- BL0175 Injection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Best-Link Bioscience, LLC
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 254 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated…
- Trial name
- reaINAVO (NCT07347600)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 32 sites in China
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio Inc.
Advanced Cancer, Gastric Cancer
Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer
This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients…
- Conditions
- Advanced Cancer, Gastric Cancer, Breast Cancer, Pancreatic Cancer
- Trial name
- GEN602 (NCT03775525)
- Testing
- GZ17-6.02, Capecitabine
- Where
- 4 sites in United States
- Volunteers
- 127 people
- Sponsor
- Genzada Pharmaceuticals USA, Inc.
Postmenopause, Breast Cancer
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line).
- Trial name
- ACT-FASTER: (NCT01171417)
- Where
- 92 sites in Germany
- Volunteers
- 570 people
- Sponsor
- AstraZeneca
Stomatitis, Oral Mucositis
Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention or treatment of everolimus-associated stomatitis…
- Conditions
- Stomatitis, Oral Mucositis, Neoplasm of the Breast, Malignant Tumor of Breast
- Trial name
- NCT02229136
- Testing
- Miracle Mouthwash Plus Hydrocortisone, Prednisolone
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- US Oncology Research
Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4…
- Conditions
- Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms
- Trial name
- NCT04561362
- Testing
- BT8009, Pembrolizumab
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 329 people
- Sponsor
- BicycleTx Limited
Neoplasms, Breast Neoplasms
Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC
- Conditions
- Neoplasms, Breast Neoplasms, Breast Neoplasms, Triple-Negative, Breast Cancer
- Trial name
- NCT04596150
- Testing
- CX-2009, CX-072
- Where
- 42 sites in United States, South Korea and 1 more
- Volunteers
- 125 people
- Sponsor
- CytomX Therapeutics
Breast Cancer
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I…
- Trial name
- NCT02088684
- Testing
- LEE011, BYL719, fulvestrant
- Where
- 11 sites in United States, France and 6 more
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast…
- Trial name
- NCT00417885
- Testing
- exemestane, sunitinib malate
- Where
- 3 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- Pfizer