Clinical trials: Hormone Receptor Positive，HER2-negative Breast Cancer
Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy…
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer, Stage IIA Breast Cancer
- Trial name
- NCT01293032
- Testing
- Neoadjuvant Therapy, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis
- Where
- 8 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- Virginia Commonwealth University
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Breast Cancer
Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer
This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer. Palbociclib is a drug that may stop cancer cells from growing.
- Trial name
- NCT02040857
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- 10 sites in United States
- Volunteers
- 162 people
- Sponsor
- Dana-Farber Cancer Institute
HER2 Negative Breast Cancer Not Immediately Operated
Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)
Women aged 70 years or older, newly diagnosed for locally advanced unilateral breast cancer, with a histological diagnosis of invasive mammary carcinoma, positive hormone receptors, HER2 status Negative, not immediately operable…
- Trial name
- CALHYS (NCT05664893)
- Testing
- Ribociclib Oral Tablet
- Where
- France
- Sponsor
- Centre Antoine Lacassagne
Breast Cancer
Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery
RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of letrozole on the tumor on a molecular level…
- Trial name
- NCT00651976
- Testing
- letrozole, Blood Collection, biopsy/lumpectomy/mastectomy
- Where
- 5 sites in United States
- Volunteers
- 213 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Breast Cancer, HER 2 Negative Breast Cancer
Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment.
- Conditions
- Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
- Trial name
- NCT07102940
- Testing
- Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v), Dose dense Adriamycin-cyclophosphamide (AC) i.v
- Volunteers
- 50 people
- Sponsor
- George Washington University
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
- Trial name
- MONARCH 1 (NCT02102490)
- Testing
- Abemaciclib
- Where
- 36 sites in United States, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression.
- Trial name
- NCT02291913
- Testing
- Everolimus, Exemestane, Tamoxifen
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- SCRI Development Innovations, LLC
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07391774
- Testing
- Anastrozole, Biospecimen Collection, Bone Scan
- Where
- 258 sites in United States, Puerto Rico
- Volunteers
- 1,978 people
- Sponsor
- National Cancer Institute (NCI)
HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms
A Safety Study of SGN-LIV1A in Breast Cancer Patients
This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
- Conditions
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms
- Trial name
- NCT01969643
- Testing
- ladiratuzumab vedotin, Trastuzumab
- Where
- 38 sites in United States
- Volunteers
- 290 people
- Sponsor
- Seagen Inc.
Breast Cancer Recurrent
Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer
POLAR is a phase III clinical trial, which will test the safety and efficacy of an investigational combination of drugs to learn whether the combination of drugs works for a specific cancer.
- Trial name
- POLAR (NCT03820830)
- Testing
- Palbociclib 125mg, Standard endocrine therapy
- Where
- 53 sites in Austria, France and 4 more
- Volunteers
- 405 people
- Sponsor
- ETOP IBCSG Partners Foundation
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
Breast Cancer, Advanced HR+/HER2- Breast Cancer
Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable…
- Conditions
- Breast Cancer, Advanced HR+/HER2- Breast Cancer, Advanced Triple-Negative Breast Cancer
- Trial name
- SATROPIN (NCT07367178)
- Testing
- Sacituzumab Govitecan (SG), Atropine, G-CSF (Granulocyte colony-stimulating factor)
- Volunteers
- 30 people
- Sponsor
- MedSIR
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
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.
Breast Cancer
Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer
This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks).
- Trial name
- MAPPER (NCT06361940)
- Testing
- Aromatase inhibitors or tamoxifen
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- Medical College of Wisconsin
Metastatic Breast Cancer, Triple Negative Breast Cancer
Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer
This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- NCT04134884
- Testing
- Talazoparib, ASTX727
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- Kathy Miller
Breast Cancer
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast…
- Trial name
- NCT05132790
- Testing
- SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily, SBRT
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shengjing Hospital
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)